Trials / Recruiting
RecruitingNCT05923008
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-11-14
- Primary completion
- 2024-11-30
- Completion
- 2026-10-31
- First posted
- 2023-06-28
- Last updated
- 2023-11-29
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05923008. Inclusion in this directory is not an endorsement.