Cadonilimab treatment for advanced colorectal cancer that hasn't responded to other therapies

Cadonilimab (bispecific Anti-PD-1/CTLA-4 Antibody) for PD-1/PD-L1 Blockade-refractory, Microsatellite Instability-high (MSI-H) or Mismatch Repair-deficient (dMMR), Advanced Colorectal Cancer: a Single Group, Multicenter, Phase 2 Trial

This study is testing if a new treatment called Cadonilimab can help people with advanced colorectal cancer that hasn't worked with other therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: pembrolizumab, nivolumab, ipilimumab, Cadonilimab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05426005 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Cadonilimab in patients with advanced colorectal cancer that is mismatch repair-deficient (dMMR) and microsatellite instability-high (MSI-H), specifically those who have not responded to previous PD-1 or PD-L1 blockade therapies. The study aims to enroll patients with stage IV colorectal cancer and assess their response to the treatment based on established criteria. Participants will be monitored for progression-free survival and overall response rates to determine the effectiveness of Cadonilimab compared to existing treatment options.

Who should consider this trial

Good fit: Ideal candidates include individuals with stage IV colorectal cancer that is dMMR/MSI-H and have previously failed PD-1 or PD-L1 therapies.

Not a fit: Patients who have not been diagnosed with dMMR/MSI-H colorectal cancer or those who have not previously received PD-1 or PD-L1 therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have exhausted other immunotherapy options.

How similar studies have performed: Other studies have shown promising results with PD-1/PD-L1 blockade therapies in similar patient populations, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
5. Subjects with stage IV colorectal cancer must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
6. Previous treatment with an anti-PD-1 or PD-L1 monoclonal antibody for advanced or metastatic colorectal cancer has failed. Treatment failure was defined as: disease progression or unacceptable toxicity during treatment or within 6 months after the last treatment.
7. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.

Exclusion Criteria:

1. Previously received anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody.
2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
3. Heart failure grade III/IV (NYHA-classification).
4. Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
5. Subjects with known allergy to the study drugs or to any of its excipients.
6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
7. Breast- feeding or pregnant women.
8. Lack of effective contraception.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yanhong Deng, M.D.

Conditions Colorectal Cancer Stage IV; Mismatch Repair-deficient; Microsatellite Instability-high; PD-1; CTLA-4; Immunotherapy