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New treatment option for Colorectal Cancer (Diagnosis)
Official title A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
ClinicalTrials.gov ID: NCT07244705
What this study is testing
What is ABT-301?
ABT-301 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colorectal cancer (diagnosis).
Also referred to as MPT0E028, Imofinostat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participant must submit an archival formalin-fixed, paraffin-embedded tumor specimen collected within 5 years before screening. If archival specimens...
- Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or nonMSI-H by polymerase chain reaction (PCR) (Appendix 13).
You likely can't join if
- History of leptomeningeal disease.
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
- Participants with the following conditions are eligible for the study: autoimmune-related hypothyroidism on thyroid-replacement hormone are eligible...
- Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis...
- Active tuberculosis.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Must be present outside the CNS.
- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
- There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study intervention.
- The participant has not undergone stereotactic radiotherapy within seven days prior to initiation of study intervention, whole brain radiotherapy within 14 days prior to initiation of study intervention, neurosurgical...
- The participant has no ongoing requirement for corticosteroids as therapy for CNS disease. NOTE: Anticonvulsant therapy at a stable dose is permitted. Asymptomatic participants with CNS metastases newly detected at...
- Uncontrolled tumor-related pain:
- Participants requiring pain medication must be on a stable regimen at study entry.
- Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should recover from the effects of radiation...
- Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- Treatment with any investigational therapy within 28 days prior to initiation of study intervention.
- Treatment with the following pharmaceutical or herbal agents within 14 days prior to initiation of study intervention:
- Known to be moderate or strong inhibitors or inducers of CYP3A4 (Appendix 9).
- Known to be sensitive or narrow therapeutic index substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 (Appendix 10). \- Prior treatment with any immunotherapy agent, including CD137 agonists or immune checkpoint blockade...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within two weeks...
- Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.
- Metastatic disease that involves major airways or blood vessels or centrally located mediastinal tumor masses (\<30 mm from the carina) of large volume.
- History of intra-abdominal inflammatory process within 6 months prior to initiation of study intervention, including but not limited to peptic ulcer disease, diverticulitis, or colitis.
- Curative radiotherapy within 28 days and abdominal/pelvic radiotherapy within 60 days prior to initiation of study intervention, except palliative radiotherapy to bone lesions within seven days prior to initiation of...
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study intervention, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury...
- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID). NOTE: Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed. If the Investigator has...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Liverpool, New South Wales, Australia
- Macquarie Park, New South Wales, Australia
- Randwick, New South Wales, Australia
- Greenslopes, Queensland, Australia
- Woodville South, South Australia, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- Nedlands, Western Australia, Australia
- Kaohsiung City, Taiwan
- New Taipei City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liverpool, New South Wales, Australia; Macquarie Park, New South Wales, Australia; Randwick, New South Wales, Australia; Greenslopes, Queensland, Australia; Woodville South, South Australia, Australia; Clayton, Victoria, Australia and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.