CompletedPhase 1/2

The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334.

China28 participantsStarted 2023-08-09

Plain-language summary

This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
✓. Male or female subjects ≥ 18 years old;
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
✓. Anticipated life expectancy of ≥ 12 weeks;
✓. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；

Exclusion criteria

✕. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
✕. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
✕. History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
✕. Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
✕. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;

What they're measuring

Number of patients with treatment-related adverse events

Timeframe: Up to 60 days post last dose

Percentage of subjects woth Dose-Limitine toxicities(DLTs)

Timeframe: Up to 28 days following first dose

Trial details

NCT IDNCT05774873

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-20

View on ClinicalTrials.gov More Advanced Solid Tumors trials