A Study of IBI363 in Subjects With Advanced Melanoma

May 14, 2025 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma

This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute, Beijing, China,
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
    • Henan
      • Zhengzhou, Henan, China, 450044
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
    • Hunan
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330052
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
    • Yunan
      • Kunming, Yunan, China, 650118
        • Recruiting
        • Yunan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.
  2. At least one measurable lesion (target lesion) per RECIST v1.1.
  3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  4. Life expectancy of 3 months or more.
  5. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

Exclusion Criteria:

  1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
  2. Active or symptomatic central nervous system metastasis.
  3. At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin<90 g/L; Absolute neutrophil count (ANC)<1.5 × 109/L; Platelet count<100 × 109/L.
  4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin>1.5 × ULN; AST or ALT>3 × ULN; If it is tumor liver metastasis, AST or ALT>5.0 × ULN; Serum creatinine>1.5 × ULN or CCr<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin<30 g/L.
  5. At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).
  6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.
  7. Uncontrolled bleeding or known tendency to bleed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI363
Biological: IBI363
IBI363 monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AE（Adverse event）
Time Frame: 2 years
2 years
ORR（Objective response rate）
Time Frame: 2 years
2 years
DoR（duration of response）
Time Frame: 2 years
2 years
PFS (progression free survival)
Time Frame: 2 years
2 years
DCR (disease control rate)
Time Frame: 2 years
2 years
TTR (time to response)
Time Frame: 2 years
2 years
TTP (time to progression)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
OS（overall survival）
Time Frame: 2 years
2 years
PK concentration: IBI363 serum concentration
Time Frame: 2 years
2 years
ADA (Anti-drug antibody)
Time Frame: 2 years
2 years
Nab (Neutralizing antibody)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

June 6, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

October 7, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI363A201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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