Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.

Study Overview

• Status: Recruiting
• Conditions: Triple-negative Breast Cancer; Cadonilimab
• Intervention / Treatment: Drug: Cadonilimab

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jie Xiong, PhD; Phone Number: +86-15927611872; Email: xxiongjie2000@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Jie Xiong; Phone Number: +8615927611872; Email: xxiongjie2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recurrent or metastatic TNBC patients;
• TNBC defined by immunohistochemistry as ER<1%, PR<1%, Her2=0~1+, or 2+ while HER2 Fish test shows no amplification；
• Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC；When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment；
• ages 18 to 75 years at the time of signing the informed consent form (ICF);
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1);
• acceptable renal and liver function;

Exclusion Criteria:

• They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)；
• Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases；
• Patients with an active autoimmune disease that requires systemic treatment in the past two years；
• A known history of primary immunodeficiency；
• Pregnant or lactating women；
• Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm	Drug: Cadonilimab; Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.; Other Names: physician's choice of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.	From the time of informed consent signed through 90 days after the last dose of drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Overall survival	Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.	Up to 2 years
Disease control rate	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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Study Chair: Yanxia Zhao, PhD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: chemotherapy; triple negative breast cancer; Cadonilimab
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: Sophia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No