Actively Recruiting
Study of ABT-301 With Tislelizumab and Bevacizumab in pMMR/Non-MSI-H Locally Advanced or Metastatic Colorectal Cancer
Led by Anbogen Therapeutics, Inc. · Updated on 2025-11-24
66
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Anbogen Therapeutics, Inc.
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and best dosing of a drug called ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with a type of colorectal cancer called proficient mismatch repair (pMMR)/non-microsatellite instability-high (non-MSI-H) colorectal cancer. This study aims to find the highest safe dose of ABT-301 and the recommended dose for future studies while evaluating its effects in advanced or metastatic cases. Participants will take ABT-301 orally either once or twice daily in 21-day treatment cycles. Alongside ABT-301, participants will receive tislelizumab (200 mg) and bevacizumab (7.5 mg/kg) via intravenous infusion on the first day of each 21-day cycle. The study has two parts: a dose-escalation phase to identify safe dosing levels and a dose-optimization phase to further evaluate two selected doses for safety and activity against the cancer. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring safety and side effects, and pharmacokinetic and pharmacodynamic evaluations. These assessments occur from screening through treatment and up to 90 days after the last dose or until disease progression or death, lasting up to 28 months. The study monitors overall survival, progression-free survival, and duration of response to treatment.
CONDITIONS
Brief 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...
- Age 18 years or older at time of informed consent
- Diagnosed with pMMR/non-MSI-H advanced or recurrent colorectal cancer with at least one measurable lesion
- Received two or more prior systemic therapies including chemotherapy and possibly biologic agents
- Provided tumor tissue specimen collected within five years before screening
- Tumor identified as pMMR by immunohistochemistry or non-MSI-H by PCR
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function within 7 days prior to first dose
- Resolved acute treatment-related toxicities to Grade 1 or less (with some exceptions)
- Negative tests for Hepatitis B surface antigen, Hepatitis C antibody, and HIV antibody, with controlled HBV or HCV allowed
- Use of effective contraception consistent with local regulations during and after study
- Capable of giving signed informed consent
You will not qualify if you...
- History of leptomeningeal disease
- Active or history of autoimmune diseases or immune deficiencies, except some controlled conditions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease within three months prior to study
- Major surgery within 4 to 60 days before study start
- History of malignancy other than CRC within five years, except certain low-risk cancers
- Severe infection within four weeks prior to study
- Allergic reactions to chimeric or humanized antibodies
- Positive pregnancy test, breastfeeding, or planning pregnancy during study
- Symptomatic untreated or progressing CNS metastases
- Uncontrolled tumor-related pain or effusions needing frequent drainage
- Treatment with investigational therapy within 28 days prior to study
- Recent use of certain medications affecting CYP enzymes or immunotherapies
- Use of systemic immunosuppressive medications within two weeks prior to study
- Uncontrolled hypertension or vascular diseases within six months
- History of bleeding disorders or recent use of certain anticoagulants
- Core biopsy or minor surgery within three days before study
- History of gastrointestinal complications within six months prior to study
- Serious wounds, ulcers, or untreated fractures
- Metastatic disease involving major airways or blood vessels
- Recent radiotherapy or traumatic injury
- Chronic daily NSAID treatment
- Unable to swallow oral medications or have gastrointestinal conditions affecting absorption of ABT-301
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 months
Participants receive ABT-301 orally in 21-day cycles combined with tislelizumab and bevacizumab administered through intravenous infusions on Day 1 of each cycle. This treatment continues until disease progression or death, whichever occurs first, for up to 28 months.
IV infusions on Day 1 of every 21-day cycle and daily oral capsules throughout each cycle
Duration - 90 days
Participants are monitored for safety and tolerability for 90 days after the last dose of study treatment.
Approximately 3 post-treatment visits
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
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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