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Trial Title:
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06349408
Condition:
Locally Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI3001
Description:
The provisional dose levels are planned to be evaluated, but it is possible for
additional and/or intermediate dose levels to be added during the study.
IBI3001 is proposed to be administered by intravenous infusion (IV)
Arm group label:
Open-label: IBI3001 monotherapy
Summary:
This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of
IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors.
It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase
2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy,
safety and tolerability of IBI3001 at its RP2D.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Male or female participants ≥ 18 years old;
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
Criteria for Phase 1 only:
1. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1.
2. Has a documented (histologically- or cytologically-proven), unresectable, locally
advanced or metastatic solid tumor that is refractory to or intolerable with
standard treatment.
Key Exclusion Criteria:
1. Progressed or refractory to an antibody drug conjugate that consists of a
topoisomerase I inhibitor;
2. Plan to receive other antitumor therapy during the study excluding palliative
radiotherapy for the purpose of symptom (like pain) relief that must also not have
an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first
administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically
significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring
intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wollongong Public
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Contact:
Last name:
Daniel Brungs
Email:
Daniel.brungs@health.nsw.gov.au
Start date:
May 30, 2024
Completion date:
May 30, 2027
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/NCT06349408
