Actively Recruiting
A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
Led by Anbogen Therapeutics, Inc. · Updated on 2025-11-24
66
Participants Needed
15
Research Sites
139 weeks
Total Duration
On this page
Sponsors
A
Anbogen Therapeutics, Inc.
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older at the time of consent.
- Confirmed diagnosis of pMMR/non-MSI-H advanced or recurrent colorectal cancer with at least one measurable lesion.
- Have received at least two prior systemic therapies including chemotherapy and possibly biologic agents.
- Provide archival tumor tissue collected within 5 years before screening or a recent biopsy.
- Tumor tissues must be confirmed pMMR by IHC or non-MSI-H by PCR.
- ECOG Performance Status of 0 or 1.
- Adequate blood counts and organ function as specified by laboratory criteria within 7 days before first dose.
- Resolution of significant toxicities from prior treatments to Grade 1 or less, with exceptions for certain neuropathies and alopecia.
- Negative tests for Hepatitis B surface antigen, Hepatitis C antibody, and HIV antibody, with exceptions for controlled infections.
- Use of effective contraception according to local regulations for all participants or their partners.
- Males must use highly effective contraception during and for 90 days after study treatment.
- Females must not be pregnant or breastfeeding and meet specific sterilization or contraceptive criteria.
- Able to provide informed consent and comply with study requirements.
You will not qualify if you...
- History of leptomeningeal disease.
- Active or history of autoimmune disease or immune deficiency, with some exceptions for controlled hypothyroidism, diabetes, and certain skin conditions.
- History or evidence of pneumonitis or interstitial lung disease, except certain radiation-induced cases.
- Active tuberculosis.
- Significant cardiovascular disease within 3 months before study.
- Marked QT prolongation or risk factors for torsades de pointes.
- Major surgery within 4 weeks prior to study or planned during study.
- History of malignancy other than colorectal cancer within 5 years, with some low-risk exceptions.
- Severe infection within 4 weeks prior to study.
- Any condition that contraindicates investigational drug use or increases risk.
- History of severe allergic reactions to similar antibodies.
- Known hypersensitivity to study drugs or their components.
- Breastfeeding, pregnant, or planning pregnancy during or within 120 days after study.
- Untreated or progressing symptomatic CNS metastases, with strict criteria for asymptomatic treated lesions.
- Uncontrolled tumor-related pain or fluid accumulations requiring frequent drainage.
- Recent treatment with investigational therapy or certain medications affecting drug metabolism.
- Prior immunotherapy with disease progression.
- Use of systemic immunosuppressants within 2 weeks prior to study.
- Uncontrolled hypertension or significant vascular disease.
- History of significant bleeding disorders or recent use of certain anticoagulants.
- Recent minor surgical procedures within 3 days prior to first dose.
- History of serious gastrointestinal conditions or surgeries within 6 months.
- Serious wounds, ulcers, or fractures.
- Metastatic disease involving major airways or blood vessels.
- Recent radiotherapy within specified time frames.
- Chronic daily NSAID use, except occasional use for symptom relief.
- Inability to swallow oral medication or gastrointestinal conditions affecting absorption of ABT-301.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia, 2170
Not Yet Recruiting
2
Macquarie University Hospital (MUH)
Macquarie Park, New South Wales, Australia, 2109
Not Yet Recruiting
3
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
4
Greenslopes Private Hospital - Cyril Gilbert Cancer Centre
Greenslopes, Queensland, Australia, 4120
Not Yet Recruiting
5
The Queen Elizabeth Hospital (TQEH)
Woodville South, South Australia, Australia, 5011
Not Yet Recruiting
6
Monash University - Faculty of Medicine, Nursing and Health Sciences
Clayton, Victoria, Australia, 3800
Not Yet Recruiting
7
Austin Health - Cancer Clinical Trials Centre (CCTC)
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
8
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
9
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Not Yet Recruiting
10
E-Da Cancer Hospital
Kaohsiung City, Taiwan, 824
Not Yet Recruiting
11
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Not Yet Recruiting
12
Taipei Medical University Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 235
Not Yet Recruiting
13
National Cheng Kung University Hospital
Tainan, Taiwan, 701
Not Yet Recruiting
14
National Taiwan University Hospital - Cancer Center
Taipei, Taiwan, 100
Not Yet Recruiting
15
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Not Yet Recruiting
Research Team
R
Ryan Hua
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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