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

NCT06178601 | Recruiting Phase 2

• 1 other identifier: AK104-RC48 UC 01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• DCR

  Up to 2 years

• PFS

  Up to approximately 30 months

• OS

  Up to approximately 40 months

Study Arms (1)

RC48-ADC plus cadonilimab（AK104）

EXPERIMENTAL

RC48-ADC plus cadonilimab（AK104）

Drug: RC48-ADC; Drug: AK104

Interventions

RC48-ADC DRUG

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

RC48-ADC plus cadonilimab（AK104）

AK104 DRUG

AK104（6.0 mg/kg，intravenous (IV) infusion，Q2W）combined with RC48-ADC

RC48-ADC plus cadonilimab（AK104）

Eligibility Criteria

• Age: 18 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (2)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wang Xin Doctor

CONTACT

+86(010)87787170; WXCAMS@126.com

Study Design

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

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: August 3, 2023
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2026
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

CN (2)