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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05458219




Registration number
NCT05458219
Ethics application status
Date submitted
11/07/2022
Date registered
14/07/2022

Titles & IDs
Public title
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Scientific title
A Phase 1a/b, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI343A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI343

Experimental: Single arm - Phase 1a Dose Escalation: IBI343 will be administered intravenously (IV) at different dose levels following accelerated titration for the first 2 dose levels and traditional 3+3 dose escalation design for following levels.

Phase 1a Dose Expansion: IBI343 will be administered at dose levels which is equal or lower than MTD. Each dose level contains no more than 30 subjects (including subjects in dose escalation)

Phase 1b Dose Extension: IBI343 will be administered at RP2D.


Treatment: Drugs: IBI343
IBI343 will be administered intravenously (IV) on Day 1 of every 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events(AEs), treatment emergent adverse event (TEAEs) ,serious adverse events (SAEs)
Timepoint [1] 0 0
Up to 90 days after the last administration
Primary outcome [2] 0 0
Dose-limiting Toxicity (DLT)
Timepoint [2] 0 0
21 days after the first dose of IBI343
Secondary outcome [1] 0 0
maximum concentration (Cmax)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
area under the curve (AUC)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
clearance rate (CL)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
half-life (t1/2)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Anti-drug antibody(ADA) of IBI343
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Objective response rate (ORR)
Timepoint [6] 0 0
Through study completion, up to 2 years
Secondary outcome [7] 0 0
time to response (TTR)
Timepoint [7] 0 0
Through study completion, up to 2 years
Secondary outcome [8] 0 0
duration of response (DoR)
Timepoint [8] 0 0
Through study completion, up to 2 years
Secondary outcome [9] 0 0
disease control rate (DCR)
Timepoint [9] 0 0
Through study completion, up to 2 years
Secondary outcome [10] 0 0
progression-free survival (PFS)
Timepoint [10] 0 0
Through study completion, up to 2 years
Secondary outcome [11] 0 0
Overall survival (OS)
Timepoint [11] 0 0
through study completion, an average of 1 year
Secondary outcome [12] 0 0
apparent volume of distribution (V)
Timepoint [12] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
1. Male or female subjects, age = 18 years.
2. Phase 1a Dose Escalation: Subjects with a documented (histologically- or cytologically-proven) locally advanced unresectable or metastatic solid tumor malignancy for which standard treatment does not exist, is no longer effective, or is not acceptable to the subject.

Phase 1a Dose Expansion and Phase 1b Dose Extension: Subjects with pathologically documented locally advanced unresectable or metastatic gastric/gastro-esophageal junction adenocarcinoma or pancreatic ductal adenocarcinoma with Claudin 18.2 expression.
3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. Adequate bone marrow and organ function.
5. Subjects both male and female, who are either not of childbearing potential or who agree to use two highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with a pathologically documented lung cancer.
2. Subjects received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is greater.
3. Subjects plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study.
4. Potent cytochrome P450 3A4 (CYP3A4) and/or P450 1A2 (CYP1A2) inhibitors within 2 weeks or 5 half-lives (whichever is longer) before first administration of the study drug.
5. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) or baseline prior to first administration of the study drug.
6. Known symptomatic central nervous system (CNS) metastases.
7. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging at screening period
8. Uncontrolled diseases including:

* Uncontrolled infection requiring systematic antibiotics, antivirals or antifungals within 4 weeks prior to first administration of the study drug;
* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
* HBsAg positive and/or HBcAb positive with HBV DNA titer = 10^4 copies/mL or =2000 IU/mL or higher than lower limit of detection)
* HCV Ab positive with HCV RNA>10^3 copies/mL).
* Active syphilis infection or latent syphilis requiring treatment;
* QTc interval > 480 ms
* SBP=160mmHg or DBP=100mmHg
9. History of any arterial thromboembolic event within 6 months prior to the first administration of study drug, including myocardial infarction, unstable angina pectoris, pulmonary embolism, cerebrovascular stroke or transient ischemic attack, etc
10. Risk of intestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, or a history of abdominal cancer) or a history of inflammatory bowel disease or extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.

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
Single group
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
26/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 0 0
4217 - Benowa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shijie Liu
Address 0 0
Country 0 0
Phone 0 0
+86 18701121959
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05458219