🏛️ Verified NIH Record • Updated 2024-12-16

A Study of IBI363 in Subjects with Advanced Solid Malignancies (NCT06281678)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

🩺 Plain-English Summary (8th-Grade Level)

This 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (6 items).

Location: University of California, San Francisco (UCSF) — San Francisco, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Inadequate bone marrow and organ function;
  • Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
  • Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
  • Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
  • Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (9 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
  • Michigan Hematology & Oncology Consultants - MedOnc Troy — Troy, Michigan
  • MD Anderson Cancer Center-University of Texas — Houston, Texas
  • Oncology Consultants P.A. — Houston, Texas
  • Fred Hutchinson Cancer Center — Seattle, Washington

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗