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

Carcinoma Clinical Trial

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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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917158
• Other study ID #: 2022DZKY-106-02
• Status: Recruiting
• Phase: Phase 2
• Start date: November 23, 2022
• Est. completion date: December 2028

Study information

• Verified date: June 2023
• Source: Jinling Hospital, China
• Contact: Le Qu, M.D.
• Phone: 15720625951
• Email: septsoul[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Upper Tract Urothelial Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	5-year Disease-free survival	5 years
Secondary	Overall survival (OS)	5-year Overall Survival	Patients followed-up for 5 years
Secondary	Metastasis free survival (MFS)	5-year Metastasis free survival	Patients are followed up for 5 years