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 — DRUG
    Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
  • Sintilimab — DRUG
    Anti-PD-1 Monoclonal Antibody
  • Bevacizumab biosimilar — DRUG
    Recombinant humanized anti-VEGF monoclonal antibody
  • Limertinib — DRUG
    Third-generation EGFR-TKI
  • Osimertinib — DRUG
    Third-generation EGFR-TKI
  • Carboplatin — DRUG
    Second-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

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