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/ct2/show/NCT05774873




Registration number
NCT05774873
Ethics application status
Date submitted
8/02/2023
Date registered
20/03/2023
Date last updated
28/11/2023

Titles & IDs
Public title
IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI334A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI334 D
Treatment: Drugs - IBI334 C
Treatment: Drugs - IBI334 A
Treatment: Drugs - IBI334 B
Treatment: Drugs - IBI334 F
Treatment: Drugs - IBI334 E

Experimental: IBI334 E -

Experimental: IBI334 D -

Experimental: IBI334 C -

Experimental: IBI334 A -

Experimental: IBI334 F -

Experimental: IBI334 B -


Treatment: Drugs: IBI334 D
Subjects will receive IBI334 D once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Treatment: Drugs: IBI334 C
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Treatment: Drugs: IBI334 A
Subjects will receive IBI334 A once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Treatment: Drugs: IBI334 B
Subjects will receive IBI334 B once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Treatment: Drugs: IBI334 F
Subjects will receive IBI334 F once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Treatment: Drugs: IBI334 E
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with treatment-related adverse events
Timepoint [1] 0 0
Up to 60 days post last dose
Primary outcome [2] 0 0
Percentage of subjects woth Dose-Limitine toxicities(DLTs)
Timepoint [2] 0 0
Up to 28 days following first dose
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 60 days post last dose
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
Up to 60 days post last dose
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
Up to 60 days post last dose
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
Up to 60 days post last dose
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Up to 60 days post last dose
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
Up to 60 days post last dose

Eligibility
Key inclusion criteria
1. Male or female subjects = 18 years old;

2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

3. Anticipated life expectancy of = 12 weeks;

4. Adequate bone marrow and organ function;

Criteria for dose escalation phase only:

5. Has a documented (histologically- or cytologically-proven), unresectable, locally
advanced or metastatic solid tumor that is refractory to or intolerable with standard
treatment, or for which no standard treatment is available (mainly focused on
non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype
colorectal cancer);

6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1;

Criteria for dose expansion phase only:

7. Has a documented (histologically- or cytologically-proven), unresectable, locally
advanced or metastatic non-small-cell lung cancer, head and neck squamous cell
carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with
standard treatment, or for which no standard treatment is available;

8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participate in any other interventional clinical research except observational
(non-interventional) study or in the follow-up phase of the interventional study;

2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on
receiving any live vaccine during the study;

3. Received total pelvic radiotherapy;

4. Pyloric obstruction and/or persistent recurrent vomiting (= 3 times in 24 hours);

5. Uncontrolled diseases;

6. History of endotracheal or gastrointestinal stent implantation;

7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer,
carcinoma in situ or non-invasive tumor that were cured);

8. Women who are pregnant, have positive results in pregnancy test or are lactating;

9. Not eligible to participate in this study at the discretion of the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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/Phase 2
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
9/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Waratah
Recruitment postcode(s) [1] 0 0
2145 - Waratah

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study to evaluate the safety and tolerability of IBI334 and
determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05774873
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
Emilia Tan
Address 0 0
Country 0 0
Phone 0 0
0512-69566088
Fax 0 0
Email 0 0
lili.tan@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05774873