A Study of IBI363 in Subjects With Advanced Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081920
• Other study ID #: CIBI363A201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Haiyun Zuo
• Phone: 0512-69566088
• Email: haiyun.zuo[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2026
• Est. primary completion date: June 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• IBI363
IBI363 monotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE(Adverse event)		2 years
Primary	ORR(Objective response rate)		2 years
Primary	DoR(duration of response)		2 years
Primary	PFS (progression free survival)		2 years
Primary	DCR (disease control rate)		2 years
Primary	TTR (time to response)		2 years
Primary	TTP (time to progression)		2 years
Secondary	OS(overall survival)		2 years
Secondary	PK concentration: IBI363 serum concentration		2 years
Secondary	ADA (Anti-drug antibody)		2 years
Secondary	Nab (Neutralizing antibody)		2 years