RecruitingPhase 2NCT06281678
Official study title

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIBI363

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Innovent Biologics (Suzhou) Co. Ltd.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Interventions being studied
Drug: IBI363
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 3 months;

Reasons someone may not be able to joinExclusion criteria

1. Inadequate bone marrow and organ function; 2. 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 3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study; 4. 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; 5. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California, San Francisco (UCSF)San Francisco, California
  • Ocala Oncology CenterOcala, Florida
  • BRCR Medical CenterPlantation, Florida
  • University of Kansas Medical Center (KUMC)Fairway, Kansas
  • Michigan Hematology & Oncology Consultants - MedOnc DearbornDearborn, Michigan
  • Michigan Hematology & Oncology Consultants - MedOnc TroyTroy, Michigan
  • MD Anderson Cancer Center-University of TexasHouston, Texas
  • Oncology Consultants P.A.Houston, Texas
  • Fred Hutchinson Cancer CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2024. Always confirm current availability with the study team.

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