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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04553692
Registration number
NCT04553692
Ethics application status
Date submitted
4/09/2020
Date registered
17/09/2020
Date last updated
22/08/2024
Titles & IDs
Public title
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
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Scientific title
An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) as a Single Agent and in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
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Secondary ID [1]
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IGM-8444-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
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Colorectal Cancer
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Non Hodgkin Lymphoma
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Sarcoma
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Chondrosarcoma
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Small Lymphocytic Lymphoma
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Chronic Lymphocytic Leukemia
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Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Bone
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Aplitabart (IGM-8444)
Treatment: Drugs - FOLFIRI
Treatment: Drugs - Bevacizumab (and approved biosimilars)
Treatment: Drugs - Birinapant
Treatment: Drugs - Venetoclax
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Azacitidine
Experimental: Ph1a: Aplitabart Single Agent Alternate Dosing Escalation - Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.
Experimental: Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion - Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.
Experimental: Ph1a: Aplitabart + Birinapant Escalation and Expansion - Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously.
Experimental: Ph1a: Aplitabart + Venetoclax Escalation and Expansion - Aplitabart will be administered intravenously in combination with Venetoclax.
Experimental: Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion - Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine.
Experimental: Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion - Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine.
Experimental: Ph1b: Aplitabart + FOLFIRI + Bevacizumab - Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab
Experimental: Ph1b: FOLFIRI + Bevacizumab - Standard of Care FOLFIRI + bevacizumab will be administered intravenously
Treatment: Drugs: Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Treatment: Drugs: FOLFIRI
Chemotherapy Regimen
Treatment: Drugs: Bevacizumab (and approved biosimilars)
Targeted Therapy
Treatment: Drugs: Birinapant
SMAC-mimetic Investigational Drug
Treatment: Drugs: Venetoclax
Targeted Therapy
Treatment: Drugs: Gemcitabine
Chemotherapy
Treatment: Drugs: Docetaxel
Chemotherapy
Treatment: Drugs: Azacitidine
Chemotherapy
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
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Assessment method [1]
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Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
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Timepoint [1]
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From Cycle 1 Day 1 through 28 days after the final dose of study drug
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Primary outcome [2]
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Ph1a: To identify the recommended expansion dose for aplitabart as single agent, with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel
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Assessment method [2]
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Relationship between aplitabart dose and safety, PK, activity, and endpoints.
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Timepoint [2]
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4 weeks
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Primary outcome [3]
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Ph1b: Progression-Free Survival (PFS)
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Assessment method [3]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
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Timepoint [3]
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Study duration of approximately 36 months
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Secondary outcome [1]
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Ph1a and Ph1b: Area Under the Curve (AUC) of aplitabart
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Assessment method [1]
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Area Under the Curve (AUC) of aplitabart as a single agent and in combination with the anticancer agents listed above.
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Timepoint [1]
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At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
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Secondary outcome [2]
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Ph1a and Ph1b: Clearance (CL) of aplitabart
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Assessment method [2]
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Clearance (CL) of aplitabart as a single agent and in combination with the anticancer agents listed above.
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Timepoint [2]
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At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
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Secondary outcome [3]
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Ph1a and Ph1b: Volume of distribution (V) of aplitabart
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Assessment method [3]
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Volume of distribution (V) of aplitabart as a single agent and in combination with the anticancer agents listed above.
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Timepoint [3]
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At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
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Secondary outcome [4]
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Ph1a and Ph1b: Maximum Concentration (c-max) of aplitabart
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Assessment method [4]
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Maximum Concentration of aplitabart as a single agent and in combination with the anticancer agents listed above.
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Timepoint [4]
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At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 6 months
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Secondary outcome [5]
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Ph1a and Ph1b: Immunogenicity
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Assessment method [5]
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Immunogenicity as assessed by detection of anti-drug antibodies (ADAs) to aplitabart
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Timepoint [5]
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through end of treatment at approximately 6 months
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Secondary outcome [6]
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Ph1a and Ph1b: Objective Response Rate (ORR)
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Assessment method [6]
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Preliminary efficacy of objective response rate (ORR)
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Timepoint [6]
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Study duration of approximately 36 months
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Secondary outcome [7]
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Ph1a and Ph1b: Duration of Response (DoR)
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Assessment method [7]
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Preliminary efficacy of duration of response (DoR)
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Timepoint [7]
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Study duration of approximately 36 months
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Secondary outcome [8]
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Ph1a: Progression-Free Survival (PFS)
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Assessment method [8]
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PFS is defined as the time from first dose (Ph1a) to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
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Timepoint [8]
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Study duration of approximately 36 months
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Secondary outcome [9]
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Ph1a and Ph1b: Overall Survival (OS)
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Assessment method [9]
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OS is defined as the time from first dose (Ph1a) or randomization (Ph1b) to death due to any cause
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Timepoint [9]
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Study duration of approximately 36 months
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Secondary outcome [10]
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Ph1b: Adverse events of aplitabart + FOLFIRI + bevacizumab
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Assessment method [10]
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Incidence of treatment-related AEs graded according to the NCI Common Technology Criteria for Adverse Events (CTCAE) v5.0
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Timepoint [10]
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From Cycle 1 Day 1 through 28 days after the final dose of study drug
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Eligibility
Key inclusion criteria
Key
* Age = 18 years at time of signing ICF
* ECOG Performance Status of 0 or 1
* Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
* Adequate hepatic and renal function and adequate bone marrow reserve function.
* For combination cohorts, participants must be eligible to receive the chemotherapy or targeted agent.
* Ph1a only: No more than three prior therapeutic regimens.
* Ph1b only: Must be FOLFIRI naïve participants and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting - OR - FOLFIRI naïve participants that only received adjuvant therapy who progressed within six months after completing adjuvant therapy, and are confirmed to have locally advanced/metastatic disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Inability to comply with study and follow-up procedures.
* Prior DR5 agonist therapy.
* Concomitant use of agents well-known to cause liver toxicity.
* Concomitant use of anti-cancer agents
* Palliative radiation to bone metastases within 2 weeks prior to Day 1.
* Major surgical procedure within 4 weeks prior to Day 1.
* Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible.
* Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment
* Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment.
* Ph1b: Participants who have previously received FOLFIRI treatment in the adjuvant, advanced, or metastatic disease setting
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
272
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Westmead - Westmead
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Recruitment hospital [2]
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Southern Medical Day Care Centre - Wollongong
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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Napean Cancer Care - Kingswood
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Recruitment hospital [5]
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Tasman Health - Southport
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Recruitment hospital [6]
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Queen Elizabeth Hospital - Woodville South
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3052 - Melbourne
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Recruitment postcode(s) [4]
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2747 - Kingswood
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Recruitment postcode(s) [5]
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QLD 4215 - Southport
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Recruitment postcode(s) [6]
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5011 - Woodville South
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Country [5]
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United States of America
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Florida
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United States of America
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Indiana
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Kentucky
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United States of America
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Ohio
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Oklahoma
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Oregon
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Tennessee
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Texas
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Virginia
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Washington
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France
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Bordeaux
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France
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Dijon
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France
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Paris
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France
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Saint-Herblain
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France
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Villejuif
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Korea, Republic of
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Gangnam-gu
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Soeul
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Spain
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Barcelona
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Country [30]
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Spain
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State/province [30]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
IGM Biosciences, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.
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Trial website
https://clinicaltrials.gov/study/NCT04553692
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Humke, MD, PhD
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Address
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IGM Biosciences
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Phone
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Email
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Contact person for public queries
Name
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Clinical Trials
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Address
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Phone
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(877) 544-6728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04553692
Download to PDF