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Trial Title:
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05923008
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:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI130
Description:
Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal
of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum
of 24 months of treatment, whichever occurs first.
Arm group label:
IBI130
Summary:
This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes
a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to
enroll 20~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of
IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects
will be enrolled for phase 2.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects with 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;
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 4 weeks or 5 half-lives of the
anti-tumor regimens before the first administration of study drug, whichever is
shorter;
3. 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. Received live vaccines within 4 weeks prior to first administration of the study
drug or plan on receiving any live vaccine during the study;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sunshine Coast University
Address:
City:
Birtinya
Zip:
4575
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Michelle Morris
Phone:
07 53906057
Email:
morrismi2@ramsayhealth.com.au
Start date:
November 14, 2023
Completion date:
October 31, 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/NCT05923008
