Metastatic Colorectal CarcinomaPhase 1/2ASISTNCT05322590
BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
A Phase 1/2 study testing BXQ-350 in people with Metastatic Colorectal Carcinoma and Neuropathy, run by Bexion Pharmaceuticals, Inc. at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma, Neuropathy
- What is being tested?
- BXQ-350
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 12 sitesUnited States
- Study dates
- 9 Jan 2023to Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Must use an acceptable method of contraception such as male condom plus spermicide during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (6 months after the last dose of study intervention) and refrain from sperm donation or banking throughout this period.
- Vasectomized males are considered fertile and should still use a male condom plus spermicide as indicated above.
- Even if the female partner is pregnant, male participants should still use a condom plus spermicide, as indicated above..
- Female partners (of childbearing potential) of male participants must also use a highly effective method of contraception during the entire period of risk associated with study interventions as described above.
- FCBP
- Must use a highly effective method of contraception and avoid breastfeeding during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (9 months after the last dose of study intervention) and refrain from egg donation or banking throughout this period.
- Non-sterilized male partners must also use a male condom plus spermicide during the entire period of risk associated with study interventions as described above.
- A highly effective method of contraception is defined as one that results in a low failure rate (less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective. The participants chosen method(s) must be confirmed as highly effective prior to study entry.
- Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- 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.
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- 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.
- Have a known sensitivity to the components of BXQ-350 (SapC and DOPS).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Gabrail Cancer Center Research
Canton, Ohio, 44718
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics
Miami, Florida, 33136
University Medical Center New Orleans
New Orleans, Louisiana, 70112
UC Irvine Health
Orange, California, 92868
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Stony Brook Cancer Center
Stony Brook, New York, 11794
About this study
Official title: A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma
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.
Read the detailed description
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a cell membrane phospholipid (clinical formulation BXQ-350).Due to the presumed mechanism of action of BXQ-350, Bexion anticipates that it may have an impact on ceramides, sphingosine-1-phosphate (S1P), and inflammatory cytokine levels. In addition, pre-clinical results demonstrated that BXQ-350 induced neurite generation and protection in vitro in the PC-12 and NS20Y cell lines and significantly decreased oxaliplatin-induced cold allodynia in a model of CIPN. Thus BXQ-350 may represent a new approach to deliver a neuropathy benefit.
The unique combination of BXQ-350 along with its proven safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the standard treatment of mCRC, but also to evaluate its ability to alleviate side effects related to oxaliplatin-induced sensory neurotoxicity.
- Conditions
- Metastatic Colorectal Carcinoma, Neuropathy
- Being tested
- BXQ-350, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXQ-350Drug
Also called SapC-DOPS
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible.
PlaceboOther
Placebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible (Stage 2 only)
| Study group | Role | What they receive |
|---|---|---|
| BXQ-350 | Experimental | BXQ-350 will be administered by IV infusion Receives: Drug: BXQ-350 |
| Placebo | Placebo comparator | Placebo (0.9% normal saline) will be administered by IV infusion (Stage 2 only) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose
To determine the recommended phase 2 dose of BXQ-350, when given with mFOLFOX7 and bevacizumab, according to the investigational product (IP) related dose limiting toxicities (DLTs).
Measured: 6 months
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
To determine the safety of BXQ-350 when given with mFOLFOX7 and bevacizumab, as evidenced by the incidence of treatment emergent adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 6 months
Objective Response Rate (ORR)
To determine the ORR of BXQ-350 when given with mFOLFOX7 and bevacizumab. ORR is defined as the percentage of participants with evidence of a complete or partial response as per the Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 6 months
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
To evaluate the Cmax of BXQ-350 in combination with mFOLFOX7 and bevacizumab.
Measured: 6 months
Overall Survival (OS)
To evaluate OS in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab. OS is defined as the time from the date of randomization until date of death due to any cause.
Measured: 6 months
Progression Free Survival (PFS)
To evaluate PFS in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab. PFS is defined as the time from the date of randomization until date of disease progression or death.
Measured: 6 months
Duration of Response (DoR)
To evaluate DoR in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab. DoR is defined as the time from documentation of disease response to disease progression according to RECIST.
Measured: 6 months
Disease Control Rate (DCR)
To evaluate DCR in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab. DCR is defined as the proportion of participants whose best overall response (BOR) was complete (CR), partial response (PR) and stable disease (SD) according to RECIST.
Measured: 6 months
Total Sensory Neuropathy
To evaluate chronic neuropathy symptoms in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab. Total sensory neuropathy scores will be obtained from the EORTC QLQ-CIPN20 questionnaire.
Measured: 6 months
CIPN Assessment
To evaluate acute CIPN symptoms in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab utilizing the CIPN Assessment Tool questionnaire.
Measured: 6 months
Post Oxaliplatin Assessment
To evaluate acute CIPN symptoms post oxaliplatin dosing in participants receiving BXQ-350 with mFOLFOX7 and bevacizumab utilizing the Post-oxaliplatin Symptom questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start9 Jan 2023
- Primary completionNov 2026 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrollment will proceed in 2 stages. In the Stage 1 (open label) safety run-in phase, participants are enrolled and treated in cohorts of 3 in order to reach a maximum tolerated dose (MTD) or recommended Phase 2 Dose (RP2D). After the MTD/RP2D is established, a cohort expansion of up to 30 participants will be conducted at the RP2D. Stage 1 enrollment was completed in November 2024. In Stage 2, eligible participants will be randomized in a 1:1 ratio to receive either BXQ-350 at the RP2D or placebo (0.9% normal saline) intravenously (IV) administered in combination with mFOLFOX7 and bevacizumab.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- Chief Scientific Officer, Study director, Bexion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322590
- Sponsor's protocol ID
- BXQ-350.AG
- Acronym
- ASIST
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT05322590
- Acronym / sponsor ID
- ASIST / BXQ-350.AG
- Conditions
- Metastatic Colorectal Carcinoma, Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Bexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, CTI Clinical Trial and Consulting Services
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a cell membrane phospholipid (clinical formulation BXQ-350).Due to the presumed mechanism of action of BXQ-350, Bexion anticipates that it may have an impact on ceramides, sphingosine-1-phosphate (S1P), and inflammatory cytokine levels. In addition, pre-clinical results demonstrated that BXQ-350 induced neurite generation and protection in vitro in the PC-12 and NS20Y cell lines and significantly decreased oxaliplatin-induced cold allodynia in a model of CIPN. Thus BXQ-350 may represent a new approach to deliver a neuropathy benefit.
The unique combination of BXQ-350 along with its proven safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the standard treatment of mCRC, but also to evaluate its ability to alleviate side effects related to oxaliplatin-induced sensory neurotoxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrollment will proceed in 2 stages. In the Stage 1 (open label) safety run-in phase, participants are enrolled and treated in cohorts of 3 in order to reach a maximum tolerated dose (MTD) or recommended Phase 2 Dose (RP2D). After the MTD/RP2D is established, a cohort expansion of up to 30 participants will be conducted at the RP2D. Stage 1 enrollment was completed in November 2024. In Stage 2, eligible participants will be randomized in a 1:1 ratio to receive either BXQ-350 at the RP2D or placebo (0.9% normal saline) intravenously (IV) administered in combination with mFOLFOX7 and bevacizumab.
| Arm | Type | Receives |
|---|---|---|
| BXQ-350 | Experimental | Drug: BXQ-350BXQ-350 will be administered by IV infusion |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (0.9% normal saline) will be administered by IV infusion (Stage 2 only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXQ-350Also: SapC-DOPSBXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible. | Drug | BXQ-350 |
| PlaceboPlacebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible (Stage 2 only) | Other | Placebo |
Primary outcome
Recommended Phase 2 Dose
Time frame: 6 months
To determine the recommended phase 2 dose of BXQ-350, when given with mFOLFOX7 and bevacizumab, according to the investigational product (IP) related dose limiting toxicities (DLTs).
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: 6 months
To determine the safety of BXQ-350 when given with mFOLFOX7 and bevacizumab, as evidenced by the incidence of treatment emergent adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Objective Response Rate (ORR)
Time frame: 6 months
To determine the ORR of BXQ-350 when given with mFOLFOX7 and bevacizumab. ORR is defined as the percentage of participants with evidence of a complete or partial response as per the Response Evaluation Criteria in Solid Tumors (RECIST).
8 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Progression Free Survival (PFS)
Time frame: 6 months
Duration of Response (DoR)
Time frame: 6 months
Disease Control Rate (DCR)
Time frame: 6 months
Total Sensory Neuropathy
Time frame: 6 months
CIPN Assessment
Time frame: 6 months
Post Oxaliplatin Assessment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Scientific Officer study director
Bexion Pharmaceuticals, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BXQ-350 in people with Metastatic Colorectal Carcinoma and Neuropathy, run by Bexion Pharmaceuticals, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.