NCT05135715 is a Phase 2 clinical trial of RC48-ADC in Melanoma, Stage II, sponsored by RemeGen Co., Ltd..

Who is sponsoring NCT05135715?

NCT05135715 is sponsored by RemeGen Co., Ltd..

What drugs are being tested in NCT05135715?

Interventions in NCT05135715: RC48-ADC.

What condition does NCT05135715 study?

NCT05135715 studies Melanoma, Stage II, HER2-positive, Advanced Melanoma.

Is NCT05135715 still recruiting?

NCT05135715 is currently status unknown. Last updated 20 February 2024.

Last reviewed 2024-02-20 · How we verify

NCT05135715

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2 Last updated 20 February 2024

What this trial tests

Phase 2 trial testing RC48-ADC in Melanoma, Stage II in 50 participants. Status unknown.

Timeline

19 April 2022

Primary endpoint
30 December 2024

30 December 2025

Quick facts

Lead sponsor	RemeGen Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	19 April 2022
Primary completion	30 December 2024
Estimated completion	30 December 2025
Sites	4 locations across China

Drugs / interventions tested

RC48-ADC — full drug profile →

Conditions studied

Melanoma, Stage II — all drugs for Melanoma, Stage II →
HER2-positive — all drugs for HER2-positive →
Advanced Melanoma — all drugs for Advanced Melanoma →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Melanoma, Stage II or HER2-positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The future of targeted kinase inhibitors in melanoma.
Caksa S, Baqai U, Aplin AE. · · 2022 · cited 25× · PMID 35513054 · DOI 10.1016/j.pharmthera.2022.108200
Multiple Myeloma: Possible Cure from the Sea.
Capalbo A, Lauritano C. · · 2022 · cited 5× · PMID 35740630 · DOI 10.3390/cancers14122965

Verify or expand the search:

Other trials of RC48-ADC

Trials testing the same drug.

NCT06074484 — A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown
NCT06178601 — A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic U · Phase 2 · unknown
NCT05514158 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 · Phase 1 · unknown
NCT05302284 — A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma · Phase 3 · recruiting
NCT05297552 — A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown

Other recruiting trials for Melanoma, Stage II

Currently open trials in the same condition.

NCT07206017 — Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous M · NA · recruiting
NCT06551064 — Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients · Phase 1 · active not recruiting
NCT04990726 — Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy Wi · active not recruiting

Other RemeGen Co., Ltd. trials

Trials by the same sponsor.

NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05135715 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by RemeGen Co., Ltd.
Last refreshed: 20 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05135715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing