A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:

An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178601
• Other study ID #: AK104-RC48 UC 01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: December 2023
• Source: Shanxi Province Cancer Hospital
• Contact: Wang Xin Doctor
• Phone: +86(010)87787170
• Email: WXCAMS[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of RC48-ADC combined with AK104 in HER2-expression locally advanced or metastatic urothelial carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Voluntary agreement to provide written informed consent.

• Male or female, Age = 18 years.

• Predicted survival = 6 month.

• Histologically and/or cytologically confirmed locally advanced or metastatic urothelial carcinoma (including urothelial carcinoma originating in the renal pelvis, ureter, bladder, or urethra).

• Pior not received systemic therapy, and can not tolerant cisplatin or refuse chemotherapy.

• HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Have at least one evaluable lesion (RECIST 1.1 criteria)

• Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.

• Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

• Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

• Has received other antitumor therapy before planned start of trial treatment.

• Previously received allogeneic stem cell or parenchymal organ transplantation;

• Previously or currently suffering from congenital or acquired immunodeficiency diseases;

• known or suspected to have a history of allergies to similar drugs such as RC48-ADC and anti-PD-1, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug.

• Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.

• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.

• NYHA Class III or IV heart failure.

• Suffering from active infection requiring systemic treatment.

• Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;

• Required systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.

• 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.

• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the 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.

• Pregnancy or lactation.

• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• RC48-ADC
RC48-ADC (2.0 mg/kg,intravenous (IV) infusion,Q2W), combined with cadonilimab(AK104)
• AK104
AK104(6.0 mg/kg,intravenous (IV) infusion,Q2W)combined with RC48-ADC

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	??	Beijing
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Province Cancer Hospital	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR assessed by Investigator	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.	Up to 2 years
Secondary	DCR	The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =8 weeks) based on RECIST Version 1.1.	Up to 2 years
Secondary	PFS	Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to approximately 30 months
Secondary	OS	OS is the time from randomization to death due to any cause safety	Up to approximately 40 months