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/NCT06198426




Registration number
NCT06198426
Ethics application status
Date submitted
24/12/2023
Date registered
10/01/2024
Date last updated
11/01/2024

Titles & IDs
Public title
A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1/2, Multicenter, Open-label Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI3004A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3004

Experimental: IBI3004 -


Treatment: Drugs: IBI3004
IBI3004 will be administered. The Dose Limiting Toxicity (DLT) will be observed in the first treatment cycle. After completion of the DLT observation period, subjects will continue to receive IBI3004 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events (AEs)
Timepoint [1] 0 0
Up to 30 days post last dose
Secondary outcome [1] 0 0
Dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days post first dose

Eligibility
Key inclusion criteria
1. Subjects have the ability to understand and give written informed consent for
participation in this trial, including all evaluations and procedures as specified by
this protocol;

2. Male or female subjects = 18 years old. For Part 1, age =18 and =75 years old

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

4. Anticipated life expectancy of = 12 weeks;

5. Adequate bone marrow and organ function
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Enrolled in any other interventional clinical research except unless only involved in
an observational study (non-interventional) or in the follow-up phase of an
interventional study;

2. Received previous anti-tumor therapy: within 21 days of monoclonal antibodies or
cytotoxic therapy prior to the first dose of the study drug, or within 14 days of
small molecule targeted drugs prior to the first dose of the study drug. Received
palliative radiation therapy within 2 weeks prior to the first dose of the study drug,
or received radical radiation therapy within 4 weeks prior to the first dose of the
study drug;

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

4. Has adverse reactions resulting from previous antitumor therapies, which have not
resolved to Grade 0 or 1 toxicity according to NCI-Common Terminology Criteria for
Adverse Events (CTCAE) v5.0 (except for alopecia, fatigue, pigmentation and other
conditions with no safety risk according to investigator' discretion) or baseline
prior to the first dose of the study drug;

5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery
according to investigator' discretion, excluding needle biopsy) within 4 weeks prior
to the first dose of the study drug, or who are expected to undergo major surgery
during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2770 - Randwick

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, multicenter, dose escalation and expansion phase I /II study of
IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It
includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose
(MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian
Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size
is 46. One or more dose levels will be selected for dose expansion, each dose group will be
expanded to 30 subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06198426
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
Serena Dong
Address 0 0
Country 0 0
Phone 0 0
0512 69566088
Fax 0 0
Email 0 0
suhua.dong@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06198426