BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Metastatic Colorectal Carcinoma, Neuropathy

In brief

The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive the total and planned doses of mFOLFOX7. All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be open label and will enroll participants at increasing dose levels of BXQ-350 in order to determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the established Stage 1 dose or placebo.

Key facts

Study ID

NCT05322590

Run by

Bexion Pharmaceuticals, Inc.

People needed

195

Starts

2023-01-09

Expected to finish

2029-04-01

Last updated by the study team

2024-12-20

Who can join

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

You may qualify if…

• Participants who meet the following criteria will be considered eligible to participate in the clinical study:
• Age ≥ 18 years of age at the time of signing the informed consent.
• Participants have newly diagnosed Stage IV metastatic adenocarcinoma of the colon / rectum.
• Have measurable disease at baseline based on RECIST 1.1 as determined by the local site Investigator / radiology assessment.
• Have a life expectancy > 3 months.
• Have ECOG Performance Status of 0 or 1.
• Participants unable to walk because of paralysis, but who can sit without assistance/restraint and control a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Have acceptable liver function defined as:
• Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) for the study site; in participants with known Gilbert Syndrome, total bilirubin ≤ 3 x ULN, with direct bilirubin ≤ 1.5 x ULN).
• Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed).
• Serum albumin ≥ 3 g/ dL.
• Have acceptable renal function defined as:
• Creatinine clearance ≥ 50 mL/minute calculated using the Cockcroft-Gault formula (Cockcroft 1976): CCr = {((140 - age) x weight kg) / (72 x SCr)} x 0.85 (if female).
• Urine dipstick protein < 1 + (30 - 70 mg/dL), urine protein/creatinine ratio of < 1, OR 24 hour urine protein < 1g/24 hours.
• Have acceptable bone marrow function defined as:
• Absolute neutrophil count ≥ 1,500 cells / mm3.
• Platelet count ≥ 100,000 cells / mm3 (unsupported, no transfusion within 7 days of enrollment).
• Hemoglobin > 9.0 g/dL (unsupported, no transfusion within 7 days of enrollment).
• Have acceptable coagulation parameters (anti-coagulation allowed) defined as:
• International normalized ratio ≤ 2 x ULN unless on anticoagulation or prothrombin time within normal limits.
• Activated partial thromboplastin time within normal limits.
• Have a negative serum pregnancy test result at screening (females of childbearing potential [FCBP] only). Not applicable to participants who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or who are post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. FCBP whose partner(s) are non-sterilized males and non-sterilized male participants whose sexual partner(s) are FCBP must abstain from heterosexual activity or agree to use an acceptable method of contraception according to the following guidelines:
• The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the entire period of risk associated with study interventions and the preferred and usual lifestyle of the participant. Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods), the rhythm method, and withdrawal are not acceptable methods of contraception.
• Non-sterilized Male Participants:

You may not qualify if…

• Participants must not meet any of the following criteria:
• Have locally confirmed DNA-mismatch repair deficient or microsatellite instability (MSI) status - high Stage IV colorectal cancer.
• Participants with brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases and are off steroids for at least 7 days.
• Have a concurrent malignancy or have had another malignancy within the past 5 years prior to screening that is expected to alter life expectancy or may interfere with disease assessment.
• Have Type 1 or 2 diabetes mellitus.
• Have Reversible Posterior Leukoencephalopathy.
• Have a history of or evidence of active gastrointestinal perforation or gastrointestinal fistula.
• Have a family history of a genetic / familial neuropathy.
• Have pre-existing clinical neuropathy ≥ Grade 2 per CTCAE v5.0 from any cause.
• Have had major surgery other than a minor outpatient procedure within 28 days prior to randomization or have not recovered from major side effects of the surgery if more than 4 weeks have elapsed since surgery.
• Have poorly controlled hypertension despite the use of antihypertensive agents defined as blood pressure > 150/90 mmHg on at least 2 repeated determinations on separate days during screening period.
• Have a history of cardiac dysfunction including:
• Myocardial infarction within 6 months prior to initiation of screening.
• History of documented congestive heart failure (New York Heart Association functional classification III-IV) within 6 months prior to initiation of screening
• Active cardiomyopathy.
• Electrocardiogram with QTc > 470 milliseconds at screening.
• Have uncontrolled severe infections (acute or chronic) including HIV, Hepatitis B or C
• Have active poor wound healing (delayed healing, wound infection or fistula).
• Have evidence of active, clinically significant bleeding (e.g., gastrointestinal bleeding, hemoptysis, or gross hematuria) at screening. No bleeding diathesis, hemorrhage, or arterial/ venous thrombotic events within 6 months prior to initiation of screening, including transient ischemic attack, cerebrovascular accident, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction. Patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) or any other arterial thrombotic event are also ineligible.
• Are breast feeding or pregnant, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test.
• Have other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate the participant's participation in the clinical study or obscure proper assessment of safety and toxicity of the prescribed regimen.
• Have received prior treatment with any investigational drug within 4 weeks (28 days) prior to randomization.
• Have received prior treatment with neurotoxic chemotherapy including but not limited to oxaliplatin, cisplatin, a taxane, or a vinca alkaloid.
• Have received prior treatment with any anti-VEGF agent.
• Are receiving any agent for the treatment, prevention, or with known/hypothesized efficacy for peripheral neuropathy; including but not limited to gabapentin, pregabalin, venlafaxine, duloxetine, amitriptyline, nortriptyline, or anti-neuropathic pain topical cream.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC Irvine Health — Orange, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics — Miami, Florida, United States
• The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
• University of Louisville, James Graham Brown Cancer Center — Louisville, Kentucky, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Stony Brook Cancer Center — Stony Brook, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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