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OncoMatch/Clinical Trials/NCT06281678

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Is NCT06281678 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies IBI363 for melanoma.

Phase 2RecruitingInnovent Biologics (Suzhou) Co. Ltd.NCT06281678Data as of Jun 2026

Treatment: IBI363This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

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Extracted eligibility criteria

Treatments studied

Other

IBI363

Cancer type

Melanoma

Non-Small Cell Lung Carcinoma

Colorectal Cancer

Renal Cell Carcinoma

Disease stage

Metastatic disease required

Advanced Solid Malignancies

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: chemotherapy

Exception: within 2 weeks or 5 plasma half-lives prior to first dose

Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives

Cannot have received: targeted small molecule therapy

Exception: within 2 weeks or 5 plasma half-lives prior to first dose

Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives

Cannot have received: nitrosoureas

Exception: within 6 weeks prior to first dose and during study

Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study

Cannot have received: mitomycin C (mitomycin C)

Exception: within 6 weeks prior to first dose and during study

Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study

Cannot have received: anti-cancer monoclonal antibody

Exception: within 4 weeks prior to first dose

Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, San Francisco (UCSF) · San Francisco, California
  • Ocala Oncology Center · Ocala, Florida
  • BRCR Medical Center · Plantation, Florida
  • University of Kansas Medical Center (KUMC) · Fairway, Kansas
  • Michigan Hematology & Oncology Consultants - MedOnc Dearborn · Dearborn, Michigan

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06281678 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, targeted small molecule therapy, nitrosoureas disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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