A Phase 1/2 Clinical Study to Evaluate the Safety and Tolerability of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBI130 IBI130 |
Drug: IBI130
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.
|
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) [Up to 30 days post last dose]
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Secondary Outcome Measures
- objective response rate (ORR) [Time from first dose to best response to treatment, assessed up to 3 years]
ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
- duration of response(DoR) [Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years]
For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
- overall survival (OS) [Time from first dose to death, assessed up to 3 years]
Time from the date of the first dose to death of the subject due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Male or female subjects ≥ 18 years old;
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
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Anticipated life expectancy of ≥ 12 weeks;
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Adequate bone marrow and organ function
Exclusion Criteria:
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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;
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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;
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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;
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Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunshine Coast University | Birtinya | Queensland | Australia | 4575 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI130A101