A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer (Diagnosis), Colorectal Cancer Metastatic, Colorectal Cancer (CRC), Immunotherapy

In brief

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg/kg IV infusion Q3W, in participants with pMMR/non-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301. Participants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg/kg IV Q3W will be given in both parts of the study.

Key facts

Study ID

NCT07244705

Run by

Anbogen Therapeutics, Inc.

People needed

66

Starts

2025-11-01

Expected to finish

2028-07-01

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥18 years at the time of signing the informed consent.
• Participant with pMMR/non-MSI-H advanced/recurrent histologically confirmed CRC with at least one measurable lesion, per RECIST version 1.1.
• Participant must have received ≥2 lines of prior systemic therapy (including but not limited to chemotherapeutic agents of 5-fluorouracil, oxaliplatin, irinotecan; participant may or may not have received biologic agents such as cetuximab, panitumumab, aflibercept, ramucirumab, bevacizumab; tyrosine kinase inhibitors of regorafenib, fruquintinib).
• NOTE: Participants with BRAF V600E, HER2 amplification/ mutation, KRAS G12C mutation, NTRK gene fusion, RET fusion, may or may not have received relevant targeted therapy and failed.
• Participant must submit an archival formalin-fixed, paraffin-embedded tumor specimen collected within 5 years before screening. If archival specimens are unavailable, alternative samples, such as colon endoscopy biopsy, are acceptable.
• NOTE: For participants who consent to join the exploratory biomarker study, a fresh biopsy sample is required during the screening and treatment periods. Exceptions may be granted if tumor tissue cannot be obtained due to specific circumstances.
• Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or nonMSI-H by polymerase chain reaction (PCR) (Appendix 13).
• ECOG Performance Status of 0 or 1.
• Adequate hematologic and end-organ function, defined by laboratory data obtained within 7 days prior to the first dose of study intervention:
• Absolute neutrophil count ≥1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor support.
• Lymphocyte count >0.5 × 109/L (500/µL).
• Platelet count >100 × 109/L (100,000/μL), without transfusion.
• Hemoglobin >90 g/L (9 g/dL), participants may be transfused to meet this criterion.
• AST, ALT, and ALP <2.5 × ULN (must be ≤5 × ULN for participants with liver metastases).
• Total serum bilirubin <1.5 × ULN (<3 × ULN in the presence of documented Gilbert's syndrome [unconjugated hyperbilirubinemia] or liver metastases at baseline).
• Creatinine clearance >60 mL/min.
• Serum albumin ≥30 g/L (3 g/dL).
• International normalized ratio (INR) or activated partial thromboplastic time (aPTT) <1.5 × ULN.
• Urine dipstick for proteinuria ≤2+ (within seven days prior to the first dose of study intervention).
• 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.
• Participant must have a negative test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• NOTE: Participants with active hepatitis B virus (HBV) infection are eligible for the study if the following applies: HBV deoxyribonucleic acid (DNA) <500 IU/mL within 28 days prior to initiation of study intervention, and anti-HBV treatment (per local standard of care, e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study. Participants with positive hepatitis C virus (HCV) test are eligible for the study if they complete their antiviral therapy prior to study entry.
• Contraceptive use by participants or participant partners must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• NOTE: The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
• Male Participants:

You may not qualify if…

• History of leptomeningeal disease.
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, or ankylosing spondylitis.
• EXCEPTIONS:
• Participants with the following conditions are eligible for the study: autoimmune-related hypothyroidism on thyroid-replacement hormone are eligible for the study. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: 1. Rash must cover <10% of body surface area 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids 3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
• 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.
• EXCEPTIONS:
• o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• 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.
• NOTE: Participants are not eligible for the study if they have or are
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds).
• A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Using concomitant medications that prolong the QT/QTc interval. - Major surgical procedure, other than for diagnosis, within four weeks prior to initiation of study intervention, or anticipation of need for a major surgical procedure during the study.
• History of malignancy other than CRC within five years prior to screening.
• EXCEPTIONS:
• o Participants with malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer, are eligible for the study.
• Severe infection within four weeks prior to initiation of study intervention, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• 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.
• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tislelizumab or bevacizumab formulation.
• Participant is breastfeeding, has a positive serum pregnancy test at the Screening Visit, or is planning to become pregnant during the study intervention or within at least 120 days after the last dose of study intervention.
• Symptomatic, untreated, or actively progressing CNS metastases.
• NOTE: Asymptomatic participants with treated CNS lesions are eligible, provided that all of the following criteria are met:
• Measurable disease, per RECIST version 1.1.

Where it is running

• Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
• Macquarie University Hospital (MUH) — Macquarie Park, New South Wales, Australia
• Greenslopes Private Hospital - Cyril Gilbert Cancer Centre — Greenslopes, Queensland, Australia
• The Queen Elizabeth Hospital (TQEH) — Woodville South, South Australia, Australia
• Monash University - Faculty of Medicine, Nursing and Health Sciences — Clayton, Victoria, Australia
• Austin Health - Cancer Clinical Trials Centre (CCTC) — Heidelberg, Victoria, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
• E-Da Cancer Hospital — Kaohsiung City, Taiwan
• Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
• Taipei Medical University Shuang Ho Hospital, Ministry of Health and Welfare — New Taipei City, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan University Hospital - Cancer Center — Taipei, Taiwan
• Liverpool Cancer Therapy Centre — Liverpool, New South Wales, Australia
• Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan

Full record on ClinicalTrials.gov

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