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A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression) | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT05135715•RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+3 more criteria

Locations (4)

Fujian cancer hospital

Fuzhou, Fujian, China

The First Hospital of Jilin University

Changchun, Jilin, China

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Key Dates

Start Date

April 19, 2022

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2025

Last Updated

February 20, 2024

Enrollment

ESTIMATED participants

Conditions

Melanoma, Stage IIHER2-positiveAdvanced Melanoma

Interventions

RC48-ADC

DRUG

Contacts

Jianming Fang, Ph.D

CONTACT

+8610-58075763 jianminfang@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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