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Trial Title:
A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06198426
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI3004
Description:
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.
Arm group label:
IBI3004
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.
Criteria for eligibility:
Criteria:
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Scientia Clinical Research Ltd
Address:
City:
Randwick
Zip:
2770
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Charlotte Lemech
Phone:
61 29385807
Email:
Charlotte.lemech@scientiaclinicalresearch.com.au
Start date:
August 19, 2024
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06198426
