A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

Jinling Hospital, China

Status and phase

Enrolling

Phase 2

Conditions

UTUC

Upper Tract Urothelial Carcinoma

Carcinoma

Treatments

Drug: RC48-ADC and JS001

Study type

Interventional

Funder types

Other

Identifiers

NCT05917158

2022DZKY-106-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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 pN0-2 M0 or pTany N1-2 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 90 days of radical nephro-ureterectomy if allocated
ECOG(Eastern Cooperative Oncology Group) performance is 0~2.
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.