A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)

Advanced Melanoma Clinical Trial

Official title:

A Single-arm, Multicentre, Open Phase Ⅱa Clinical Study of RC48-ADC in the Treatment of HER2 Variant (Mutation, Amplification, Overexpression) Advanced Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135715
• Other study ID #: RC48-C020
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: RemeGen Co., Ltd.
• Contact: Jianming Fang, Ph.D
• Phone: +8610-58075763
• Email: jianminfang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.

Description:

This study is a phase IIa multicentre,single-arm, open-label, clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2- positive advanced melanoma. HER2 mutation is defined as the presence of HER2 gene mutations in primary or metastatic tumour tissue as detected by immunohistochemistry (IHC). HER2 gene mutation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Voluntary agreement to provide written informed consent.

• Male or female, Age = 18 years.

• Predicted survival = 12 weeks.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• All female subjects will be considered to be of child-bearing potential unless participants are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.

• Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

• Adequate organ function.

• All subjects must be histologically confirmed, non-resectable stage III or metastatic melanoma, except for patients with uveal or ocular melanoma.

• The subject has experienced disease progression or intolerance after receiving standard treatment in the past; Patients with disease progression within 6 months after receiving neoadjuvant or adjuvant chemotherapy regimens can be included in the clinical study.

• The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.

• According to the RECIST 1.1 standard, there is at least one measurable lesion.

Exclusion Criteria:

• Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.

• History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.

• Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.

• Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.

• History of major surgery within 4 weeks of planned start of trial treatment.

• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.

• Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).

• Pregnancy or lactation.

• Currently known active infection with HIV or tuberculosis.

• Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.

• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

• History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.

• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Related Conditions & MeSH terms

• Advanced Melanoma
• HER2-positive
• Melanoma
• Melanoma, Stage II

Intervention

Drug:
• RC48-ADC
2.0 mg/kg IV every 2 weeks

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Fujian cancer hospital	Fuzhou	Fujian
China	Zhejiang cancer hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective remission rate (ORR)	The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.	within approximately 3 years
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.	within approximately 3 years
Secondary	Duration of relief (DOR)	DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.	within approximately 3 years
Secondary	Disease control rate (DCR)	Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.	within approximately 3 years
Secondary	Overall survival (OS)	Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.	within approximately 3 years