Condition

Mismatch Repair-proficient (pMMR)/Microsatellite Stable (MSS) Locally Advanced or Metastatic Colorectal Cancer (mCRC)

Purpose of the study

To evaluate the safety, efficacy, and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab and bevacizumab once every three weeks.

Official Title

An Open-label, Multicenter, Phase 1/2 Study Exploring the Safety and Efficacy of ABT-301 in Combination With Tislelizumab and Bevacizumab in Participants with Mismatch Repair-proficient (pMMR)/Microsatellite Stable (MSS) Locally Advanced or Metastatic Colorectal Cancer (mCRC).

Who is eligible to participate?

Inclusion Criteria

• Participant with pMMR/non-MSI-H advanced/recurrent histologically confirmed colorectal cancer with at least one measurable lesion, per RECIST version 1.1.
• Participant must have received ≥2 lines of prior systemic therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤1 prior to study entry, with the exception of Grade ≤2 chemotherapy-related peripheral neuropathy or any Grade alopecia.
• Contraceptive use by participants or participant partners must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant is capable of giving signed informed consent.

Exclusion Criteria

• History of leptomeningeal disease.
• Active or history of autoimmune disease or immune deficiency.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
• Active tuberculosis.
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within three months prior to initiation of study intervention, unstable arrhythmia, or unstable angina.
• History of malignancy other than colorectal cancer within five years prior to screening.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications. ·
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. ·
• Treatment with any investigational therapy within 28 days prior to initiation of study intervention.
• Participant cannot swallow oral medications or have a GI illness that may clinically significantly affect the absorption of ABT-301 (e.g., chronic diarrhea with malabsorption).

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane