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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05135715
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

RemeGen Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jun Guo, Ph.D
Principal Investigator Affiliation Peking University Cancer Hospital & Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Stage II, HER2-positive, Advanced Melanoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: RC48-ADC

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).

Interventions

Drug: - RC48-ADC

2.0 mg/kg IV every 2 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fujian cancer hospital, Fuzhou, Fujian, China

Status

Recruiting

Address

Fujian cancer hospital

Fuzhou, Fujian,

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin,

Site Contact

Ti Wu, M.D

[email protected]

+8610-58075763

Zhejiang cancer hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Zhejiang cancer hospital

Hangzhou, Zhejiang,

Site Contact

Meiyu Fang, M.D

[email protected]

+8610-58075763

Beijing Cancer Hospital, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, ,

Site Contact

Jun Guo

[email protected]

+8610-58075763

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