Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05205109




Registration number
NCT05205109
Ethics application status
Date submitted
11/01/2022
Date registered
24/01/2022
Date last updated
30/04/2024

Titles & IDs
Public title
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
Scientific title
A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
KEYNOTE-E73
Secondary ID [2] 0 0
ATG-037-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATG-037
Treatment: Drugs - KEYTRUDA ®( Pembrolizumab)

Experimental: ATG-037+Keytruda(Pembrolizumab, MK-3475) - Part I: Dose Escalation Phase of ATG-037 Monotherapy PartII: Dose Escalation Phase and Dose Expansion Phase of ATG-037 in Upfront Combination with Keytruda(Pembrolizumab, MK-3475)


Treatment: Drugs: ATG-037
Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days.

Part II: ATG-037 will be administered orally BID for every day from C1D1.

Treatment: Drugs: KEYTRUDA ®( Pembrolizumab)
Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with Keytruda ®(Pembrolizumab) 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years).

Part II: Keytruda ®(Pembrolizumab) will be administered from C1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events and server adverse events
Timepoint [1] 0 0
One year after last patient first dose
Primary outcome [2] 0 0
DLT
Timepoint [2] 0 0
Up to 21 Days
Primary outcome [3] 0 0
MTD
Timepoint [3] 0 0
Up to 21 Days
Primary outcome [4] 0 0
RP2D
Timepoint [4] 0 0
Up to 21 Days
Secondary outcome [1] 0 0
Plasma concentration of ATG-037 and derived PK parameters
Timepoint [1] 0 0
One year after last patient first dose
Secondary outcome [2] 0 0
Inhibition of CD73 enzymatic activity in plasma
Timepoint [2] 0 0
One year after last patient first dose
Secondary outcome [3] 0 0
ORR as per RECIST v1.1 and DOR, DCR, PFS, OS evaluated by the investigators
Timepoint [3] 0 0
One year after last patient first dose

Eligibility
Key inclusion criteria
1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
2. Aged at least 18 years as of the date of consent.
3. Histological or cytological confirmation of a solid tumor that has relapsed from or refractory to standard therapies.
4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. Estimated life expectancy of a minimum of 12 weeks.
6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD>6 months).
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.
9. Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.
10. Subjects should have adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.
2. Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.
3. Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).
4. Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.
5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids.
6. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures =7 days.
7. Except for alopecia, platinum-induced peripheral neurotoxicity (=Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.
8. Subjects receiving unstable or increasing doses of corticosteroids.
9. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension defined as a blood pressure (BP) =160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Sydney
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment hospital [4] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [5] 0 0
One Clinical Research Pty Ltd - Mount Pleasant
Recruitment postcode(s) [1] 0 0
2298 - Sydney
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
WA6153 - Mount Pleasant
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Chongqing
Country [2] 0 0
China
State/province [2] 0 0
Guangdong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antengene Therapeutics Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ganessan Kichenadasse, MD
Address 0 0
Southern Oncology Clinical Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sunny He
Address 0 0
Country 0 0
Phone 0 0
187 2152 1865
Fax 0 0
Email 0 0
[email protected]
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/NCT05205109