A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.
Eligibility criteria
Qualifiers
Sign the written informed consent form and be able to comply with the visit arrangements and related procedures specified in the protocol.
Aged >= 18 years and <= 75 years, regardless of gender.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Expected survival time >= 3 months.
Disqualifiers
Documented sarcoma, mucinous carcinoma, undifferentiated carcinoma, or a combination thereof;
Confirmed low-grade or borderline tumors, or contains the above components.
Previously received IL-2/IL-15 cytokine therapy. Except for the use of IL-2/IL-15 as an adjuvant component of adoptive cell therapy or as an immunomodulatory therapy for immunocompromised subjects.
Have received small-molecule targeted therapy or oral chemotherapy within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug; have received intravenous infusion of chemotherapy drugs within 3 weeks before the first dose of the study drug; have received Chinese herbal medicines with anti-tumor indications within 2 weeks before the first dose of the study drug;
Trial design
Treatments tested in this trial
- IBI363+IBI305
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov