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

NCT05135715 | Unknown Phase 2 DMC

• 1 other identifier: RC48-C020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Melanoma, Stage II; HER2-positive; Advanced Melanoma

Keywords

RC48-ADC; HER2-positive melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  within approximately 3 years

• Duration of relief (DOR)

  within approximately 3 years

• Disease control rate (DCR)

  within approximately 3 years

• Overall survival (OS)

  within approximately 3 years

Study Arms (1)

RC48-ADC

EXPERIMENTAL

Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Drug: RC48-ADC

Interventions

RC48-ADC DRUG

2.0 mg/kg IV every 2 weeks

Also known as: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection

RC48-ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (4)

Fujian cancer hospital

Fuzhou, Fujian, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Injections

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jun Guo, Ph.D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianming Fang, Ph.D

CONTACT

+8610-58075763; jianminfang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: April 19, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: February 20, 2024

Record last verified: 2023-11

Locations

CN (4)