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Recruiting NCT06281678

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Phase II Interventional Melanoma Non-small Cell Lung Cancer Colorectal Cancer Renal Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI363.
Who it may be relevant to
Registry conditions: Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

Overview

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.

Interventions

  • Drug IBI363
    IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.

Primary outcome measures

  • Objective response rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (2)
  • Adverse Event （AE） [Time frame: Up to 90 days post last dose]
  • Dose-limiting Toxicity （DLT） [Time frame: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.]

Eligibility criteria

Inclusion criteria

  • 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;
  • Male or female subjects ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • Anticipated life expectancy of ≥ 3 months;

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • University of California, San Francisco (UCSF) — San Francisco
  • Ocala Oncology Center — Ocala
  • BRCR Medical Center — Plantation
  • University of Kansas Medical Center (KUMC) — Fairway
  • Michigan Hematology & Oncology Consultants - MedOnc Dearborn — Dearborn
  • Michigan Hematology & Oncology Consultants - MedOnc Troy — Troy
  • MD Anderson Cancer Center-University of Texas — Houston
  • Oncology Consultants P.A. — Houston
  • … and 1 more center

Identifiers

NCT: NCT06281678 · CIBI363A202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗