A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

Sponsor

Jinling Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05917158

Collaborator

(none)

Enrollment

Location

Arm

72.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Upper Tract Urothelial Carcinoma UTUC	Drug: RC48-ADC and JS001	Phase 2

Detailed Description

This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)

Actual Study Start Date :

Nov 23, 2022

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RC48-ADC and JS001	Drug: RC48-ADC and JS001 Patients in group will receive 6 x 2 week cycles of JS001 (Toripalimab) 3mg/kg in combination with RC48-ADC (Disitamab Vedotin) 2mg/kg intravenously.

Arm

Intervention/Treatment

Experimental: RC48-ADC and JS001

Drug: RC48-ADC and JS001

Patients in group will receive 6 x 2 week cycles of JS001 (Toripalimab) 3mg/kg in combination with RC48-ADC (Disitamab Vedotin) 2mg/kg intravenously.

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [5 years]
5-year Disease-free survival

Secondary Outcome Measures

Overall survival (OS) [Patients followed-up for 5 years]
5-year Overall Survival
Metastasis free survival (MFS) [Patients are followed up for 5 years]
5-year Metastasis free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent
≥18 years of age
Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted.
Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected).
Pathological tissue immunohistochemistry HER2 2~3+
Fit and willing to receive adjuvant therapy with first cycle to be commenced within 30 days of radical nephro-ureterectomy if allocated
ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1.
Available for long-term follow-up

Exclusion Criteria:

Evidence of distant metastases
Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
Un-resected macroscopic nodal disease
Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
Significant co-morbid conditions that would interfere with administration of protocol treatment
Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qu Le, Associate chief urologist, Jinling Hospital, China

ClinicalTrials.gov Identifier:

NCT05917158

Other Study ID Numbers:

2022DZKY-106-02

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Transitional Cell

Study Results

No Results Posted as of Jun 23, 2023