A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

NCT03507166 | Completed Phase 2

• 1 other identifier: RC48-C005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.

Conditions

Urothelial Carcinoma; Advanced Cancer

Keywords

RC48-ADC; HER2

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate （ORR）

  Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

  up to 24 months

Secondary Outcomes (6)

• ORR of HER2-positive patients

  up to 24 months

• Progression Free Survival (PFS)

  up to 24 months

• Duration of Response (DOR)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

• Overall Survival(OS)

  up to 24 months

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 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 - 80 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 and \< 80 years.
• Predicted survival ≥ 12 weeks.
• Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
• Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
• Measurable disease according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
• Adequate organ function, evidenced by the following laboratory results:
• Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.
• All female subjects will be considered to be of child-bearing potential unless they 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.

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.
• History of receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
• 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.
• Currently known active infection with HIV or tuberculosis.
• 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.
• known central nervous system metastases.
• Pregnancy or lactation.
• 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 (2)

Beijing Cancer Hospital

Beijing, N/A = Not Applicable, 100078, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, N/A = Not Applicable, China

Location

Related Publications (2)

• Sheng X, Wang L, He Z, Shi Y, Luo H, Han W, Yao X, Shi B, Liu J, Hu C, Liu Z, Guo H, Yu G, Ji Z, Ying J, Ling Y, Yu S, Hu Y, Guo J, Fang J, Zhou A, Guo J. Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials. J Clin Oncol. 2024 Apr 20;42(12):1391-1402. doi: 10.1200/JCO.22.02912. Epub 2023 Nov 21.

  PMID: 37988648 DERIVED

• Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.

  PMID: 33109737 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Injections

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

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

Model Details: Drug: RC48-ADC

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 24, 2018
• Study Start: December 28, 2017
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)