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A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors

NCT07124793 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-15

No results posted yet for this study

Summary

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.

Conditions

  • EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer

Interventions

DRUG

IBI363+IBI305

Each treatment cycle lasts for 21 days (the first treatment cycle is 28 days). Subjects will receive IBI363 Q3W in combination with bevacizumab Q3W until 2 years of treatment, PD, intolerable toxicity, start of new anti-tumor treatment, withdrawal of informed consent, death, or study termination (whichever occurs first).

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-09-30
Completion
2028-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124793 on ClinicalTrials.gov