Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Study ID
- NCT07612137
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IBI3005 — DRUGBispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
- Sintilimab — DRUGAnti-PD-1 Monoclonal Antibody
- Bevacizumab biosimilar — DRUGRecombinant humanized anti-VEGF monoclonal antibody
- Limertinib — DRUGThird-generation EGFR-TKI
- Osimertinib — DRUGThird-generation EGFR-TKI
- Carboplatin — DRUGSecond-generation platinum-based chemotherapy drugs
Study Details
To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- May 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 282 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1:IBI3005+Sintilimab+ Carboplatin+IBI305
- Experimental: Cohort 2:IBI3005+Sintilimab+ Carboplatin
- Experimental: Cohort 3:IBI3005+Limertinib/Osimertinib
Primary Outcome Measure
Number of subjects with adverse events [ Time Frame: Up to 3 years ]
Central Contacts
- Yang Luo+86 21 3183 7200
- Yulong Zhang+86 21 3183 7200
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