Solid TumorPhase 1NCT06576037
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
A Phase 1 study testing CBP-1019, Oxaliplatin and Leucovorin in people with Solid Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CBP-1019, Oxaliplatin and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 1 Jun 2029
- Phase
- Phase 1
- 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
- Patients must have histologically or cytologically confirmed malignancy of epithelial origin other than ovarian cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients must have received at least one prior line of systemic standard therapy, and have either disease progression or intolerable toxicity after standard treatment.
- In the dose expansion, Regimen A will enroll patients with metastatic pancreatic cancer with concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 1), Regimen B will enroll patients with metastatic colorectal cancer concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 2), Regimen C will enroll patients with metastatic solid tumors of epithelial origin who have received prior anti-PD-(L)1 therapy (Cohort 3), and Regimen D will enroll patients with metastatic castration-resistant and taxane-treated prostate cancer (Cohort 4).
- Patients (with the exception of those with prostate cancer) must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with computed tomography (CT) scan,PET-CT, magnetic resonance imaging (MRI) scan, or calipers by clinical exam.
- Note: Prostate cancer patients must meet ≥1 of the following Prostate Cancer Clinical Trials Working Group 3 criteria [95]:
- Progression in measurable disease.
- Bone disease progression defined by the appearance of ≥2 new bone lesions.
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- Prostate-specific antigen (PSA) progression defined as ≥2 sequential rises in PSA obtained ≥1 week apart with a minimal starting value of ≥1 ng/mL. A PSA value ≥2 ng/mL is required at study entry.
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (Appendix 1).
- Must have adequate organ and marrow functions as defined below:
- Absolute neutrophil count (ANC) ≥1.5× 109/L: growth factor support is not allowed within 2 weeks of study treatment initiation.
- Hemoglobin ≥9 g/dL: packed RBC transfusion is allowed as long as there is no active bleeding.
- Platelets ≥100× 109/L: transfusion is not allowed within 2 weeks of study treatment initiation.
- Total bilirubin ≤1.5× upper limit of normal (ULN); or total bilirubin <3.0× ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert's syndrome.
- Alanine aminotransferase (ALT) and AST ≤2.5× the upper limit of the reference range, or ≤ 5× the upper limit of the reference range for patients with liver metastases.
- Serum albumin ≥3 g/dL.
- Urinalysis ≤1 proteinuria, or urine protein/creatinine ratio (UPCR) ≤1 mg/mg (≤113.2 mg/mmol), or 24-h urine protein ≤1 g (applies to bevacizumab-based regimen only).
- Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× ULN if not on therapeutic anticoagulation.
- Calculated creatinine clearance (CrCl) ≥50 mL/min by the Cockcroft-Gault method as below or 24-hour urine collection.
- CrCl = (140-age) × (weight/kg) x Fa / (72 × serum creatinine mg/dL). a where F= 0.85 for females and F=1 for males 9. Patients whose baseline pulse oximetry is at least 90% on room air.
- 10. Fridericia's corrected QT interval (QTcF =QT/∛(60/HR) ) ≤460 ms for males and ≤480 ms for females on electrocardiogram (ECG) conducted at rest during screening.
- Note: Patients with an atrioventricular pacemaker or other condition (e.g., right bundle branch block) that renders the QT measurement invalid are an exception and this criterion does not apply.
- 11. The effects of study drugs on the developing human fetus are unknown. For this reason and because Class II drugs as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, throughout the study treatment period, and for 6 months after study treatment completion (Refer to Pregnancy Assessment Policy MDACC Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- 12. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to study treatment initiation (Cycle 1 Day 1).
- 13. Men and women enrolled on this protocol must agree to use adequate contraception during the study treatment period and for 6 months after completion of study treatment.
- 14. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimens are eligible for this trial.
- Agree to provide baseline tumor specimens: archival tissue block, or 10 FFPE slides, or a pre-treatment biopsy.
- Patients must have adequate washout from prior therapy at the time of study treatment initiation: 3 weeks from any treatment specifically for systemic tumor control; 2 weeks from cytotoxic agents that were administered weekly; 6 weeks from nitrosoureas or mitomycin C; and 5 half-lives from targeted agents with half-lives and pharmacodynamic effects lasting <5 days.
Who cannot join
- Has received an investigational non-myelosuppressive agent within 14 days prior to study treatment initiation or an investigational myelosuppressive agent within 21 days prior to study treatment initiation.
- Uncontrolled intercurrent illness including but not limited to:
- Ongoing or active infection requiring IV antibiotics.
- Symptomatic congestive heart failure (New York Heart Association Class III or IV).
- History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months before study enrollment.
- Lesions invading or encasing any major blood vessels and cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation; uncontrolled hypertension defined as sustained blood pressure >140 mmHg systolic / >90 mmHg diastolic despite optimal antihypertensive treatment (applies to bevacizumab-based regimen only).
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- History or current evidence of uncontrolled ventricular arrhythmia.
- Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
- Clinically significant bleeding or active gastric or duodenal ulcer.
- Chronic diarrhea disease considered to be clinically significant by the investigator.
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the first dose of study treatment, or any GI disorders associated with a high risk of perforation or fistula formation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Note: Patients with a diagnosis of incidental subsegmental pulmonary embolism or deep vein thrombosis are allowed if stable, asymptomatic, and on a stable dose of anticoagulant for at least 1 week before the first dose of study treatment.
- Unresolved clinically significant Grade ≥1 toxicity from prior therapy. Note: Patients who were exposed to prior treatment with any of the combination regimens that experienced intolerable or severe toxicity, even if they recovered; or who required dose reduction of chemotherapy or enzalutamide in their standard of care therapies should be excluded.
- History of allergic reactions to the study drugs or any of their components.
- Has not recovered from a major surgical procedure or significant traumatic injury (i.e., still needing additional surgical or medical care for these issues): major surgical procedures ≤28 days prior to study entry or minor surgical procedures ≤7 days prior to study entry. No waiting period is required following port-a-cath or other central venous access placement. Patients must have complete wound healing from major or minor surgery before the first dose of study treatment.
- Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a therapeutic device for cancer control, then agreement with the investigator and the Sponsor is required to establish eligibility.
- Has received a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: Bacille Calmette-Guérin vaccine, measles, mumps, rabies, rubella, typhoid vaccine, varicella/zoster, and yellow fever. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed. COVID-19 vaccines including killed virus are allowed.
- Symptomatic primary tumors or metastasis in the brain and/or central nervous system (CNS) that are uncontrolled with antiepileptics and/or require prednisone >10 mg/day or equivalent.
- Note: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, new, or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of study treatment.
- Evidence of leptomeningeal or lymphangitic carcinomatosis.
- Patients with a history of stem cell or solid organ transplantation.
- Breastfeeding or pregnant.
- Known history of positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Patients with a history of positive HIV test result who meet all the following eligibility criteria may be enrolled:
- Have a T cell (CD4+) count ≥350 cells/μL.
- No history of opportunistic infections or other malignancies.
- Have an HIV viral load less than 400 copies/mL.
- In the opinion of the investigator, their antiretroviral therapy or other HIV treatments will not interfere with the activity of the investigational product or cause any confusion with the assessment of the investigational drug toxicities.
- Patients with a history of positive HBV or HCV test result must have:
- Negative viral load test (HBV DNA or HCV RNA) at screening.
- Ability to take oral medications without medical history of malabsorption or other chronic GI disease, or other conditions that may hamper compliance and/or absorption of the study agent (applies to enzalutamide-based regimen only).
- Concurrent immunosuppressive therapy or steroid therapy (>10 mg/day prednisone or equivalent) (applies to pembrolizumab-based regimen only).
- History of autoimmune disease including but not limited to inflammatory bowel disease, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis that required systemic therapy in the past 2 years (applies to pembrolizumab-based regimen only).
- Note: Patients with vitiligo, resolved childhood asthma/atopy, hypothyroidism on stable hormone replacement, controlled asthma, type I diabetes, Graves' disease, or Hashimoto's disease are not excluded.
- History of Grade ≥2 immune related reactions (i.e., uveitis, etc.) that prompted prior immune checkpoint inhibitor therapy discontinuation (applies to pembrolizumab-based regimen only).
- Note: Patients with adequately treated skin rash other than Steven-Johnson syndrome, toxic epidermal necrolysis, or other severe forms of dermatitis and patients on replacement therapy for endocrinopathies are not excluded (applies to pembrolizumab-based regimen only).
- History of interstitial lung disease or (non-infectious) pneumonitis that required steroids or current pneumonitis (applies to pembrolizumab-based regimen only).
- History of Grade ≥3 allergic reaction to treatment with a monoclonal antibody (applies to bevacizumab-based and pembrolizumab-based regimens only).
- Patients who experienced oxaliplatin-related Grade 3 peripheral neuropathy or any grade neuropathy that triggered oxaliplatin discontinuation (applies to FOLFOX-based regimens only).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Siqing Fu, MD,PHD, 713-792-4318, siqingfu@mdanderson.org
Siqing Fu, MD,PHD
About this study
An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.
Read the detailed description
Primary Objectives:
To determine the safety and tolerability of CBP-1019 combinations (Regimen A: CBP-1019 plus FOLFOX; Regimen B: CBP-1019 plus FOLFOX with bevacizumab; Regimen C: CBP-1019 plus pembrolizumab; and Regimen D: CBP-1019 plus enzalutamide) in metastatic solid tumors of epithelial origin.
To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin.
Secondary Objective:
To evaluate other indicators of the antitumor activity of CBP-1019 combinations.
Exploratory Objectives:
To explore potential biomarkers associated with response/resistance and major clinical outcomes (toxicity and antitumor activities) through molecular profiling at the DNA, RNA and protein levels.
To explore patient-reported outcomes (PROs).
- Conditions
- Solid Tumor
- Being tested
- CBP-1019, Oxaliplatin, Leucovorin, 5-FLUOROURACIL, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-1019Drug
Given by vein (IV)
OxaliplatinDrug
Given by vein (IV)
LeucovorinDrug
Given by vein (IV)
5-FLUOROURACILDrug
Given by vein (IV)
BevacizumabDrug
Given by vein (IV)
PembrolizumabDrug
Given by vein (IV)
EnzalutamideDrug
Given by mouth
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Dose Escalation CBP-1019 + FOLFOX | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FLUOROURACIL |
| Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FLUOROURACIL; Drug: Bevacizumab |
| Part 1C: Dose Escalation CBP-1019 + Pembrolizumab | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Pembrolizumab |
| Part 1D: Dose Escalation CBP-1019 + Enzalutamide | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Enzalutamide |
| Part 2A: Pancreatic CBP-1019 + FOLFOX | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FLUOROURACIL |
| Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FLUOROURACIL; Drug: Bevacizumab |
| Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Pembrolizumab |
| Part 2D: CRPC CBP-1019 + Enzalutamide | Experimental | Participants will be administered the study treatments on an outpatient basis. Receives: Drug: CBP-1019; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start31 Oct 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576037
- Sponsor's protocol ID
- 2024-0474
- Other IDs
- NCI-2024-07312
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
- ClinicalTrials.gov ID
- NCT06576037
- Acronym / sponsor ID
- 2024-0474
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 28 Aug 2024 (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.
An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.
Detailed description
Primary Objectives:
To determine the safety and tolerability of CBP-1019 combinations (Regimen A: CBP-1019 plus FOLFOX; Regimen B: CBP-1019 plus FOLFOX with bevacizumab; Regimen C: CBP-1019 plus pembrolizumab; and Regimen D: CBP-1019 plus enzalutamide) in metastatic solid tumors of epithelial origin.
To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin.
Secondary Objective:
To evaluate other indicators of the antitumor activity of CBP-1019 combinations.
Exploratory Objectives:
To explore potential biomarkers associated with response/resistance and major clinical outcomes (toxicity and antitumor activities) through molecular profiling at the DNA, RNA and protein levels.
To explore patient-reported outcomes (PROs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Dose Escalation CBP-1019 + FOLFOX | Experimental | Drug: CBP-1019, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FLUOROURACILParticipants will be administered the study treatments on an outpatient basis. |
| Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab | Experimental | Drug: CBP-1019, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FLUOROURACIL, Drug: BevacizumabParticipants will be administered the study treatments on an outpatient basis. |
| Part 1C: Dose Escalation CBP-1019 + Pembrolizumab | Experimental | Drug: CBP-1019, Drug: PembrolizumabParticipants will be administered the study treatments on an outpatient basis. |
| Part 1D: Dose Escalation CBP-1019 + Enzalutamide | Experimental | Drug: CBP-1019, Drug: EnzalutamideParticipants will be administered the study treatments on an outpatient basis. |
| Part 2A: Pancreatic CBP-1019 + FOLFOX | Experimental | Drug: CBP-1019, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FLUOROURACILParticipants will be administered the study treatments on an outpatient basis. |
| Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab | Experimental | Drug: CBP-1019, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FLUOROURACIL, Drug: BevacizumabParticipants will be administered the study treatments on an outpatient basis. |
| Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab | Experimental | Drug: CBP-1019, Drug: PembrolizumabParticipants will be administered the study treatments on an outpatient basis. |
| Part 2D: CRPC CBP-1019 + Enzalutamide | Experimental | Drug: CBP-1019, Drug: EnzalutamideParticipants will be administered the study treatments on an outpatient basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Patients must have histologically or cytologically confirmed malignancy of epithelial origin other than ovarian cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients must have received at least one prior line of systemic standard therapy, and have either disease progression or intolerable toxicity after standard treatment.
- In the dose expansion, Regimen A will enroll patients with metastatic pancreatic cancer with concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 1), Regimen B will enroll patients with metastatic colorectal cancer concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 2), Regimen C will enroll patients with metastatic solid tumors of epithelial origin who have received prior anti-PD-(L)1 therapy (Cohort 3), and Regimen D will enroll patients with metastatic castration-resistant and taxane-treated prostate cancer (Cohort 4).
- Patients (with the exception of those with prostate cancer) must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with computed tomography (CT) scan,PET-CT, magnetic resonance imaging (MRI) scan, or calipers by clinical exam.
- Note: Prostate cancer patients must meet ≥1 of the following Prostate Cancer Clinical Trials Working Group 3 criteria [95]:
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (40 listed)
- Has received an investigational non-myelosuppressive agent within 14 days prior to study treatment initiation or an investigational myelosuppressive agent within 21 days prior to study treatment initiation.
- Uncontrolled intercurrent illness including but not limited to:
- Note: Patients with a diagnosis of incidental subsegmental pulmonary embolism or deep vein thrombosis are allowed if stable, asymptomatic, and on a stable dose of anticoagulant for at least 1 week before the first dose of study treatment.
- Unresolved clinically significant Grade ≥1 toxicity from prior therapy. Note: Patients who were exposed to prior treatment with any of the combination regimens that experienced intolerable or severe toxicity, even if they recovered; or who required dose reduction of chemotherapy or enzalutamide in their standard of care therapies should be excluded.
- History of allergic reactions to the study drugs or any of their components.
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 |
|---|---|---|
| CBP-1019Given by vein (IV) | Drug | Part 1A: Dose Escalation CBP-1019 + FOLFOX, Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab, Part 1C: Dose Escalation CBP-1019 + Pembrolizumab, Part 1D: Dose Escalation CBP-1019 + Enzalutamide, Part 2A: Pancreatic CBP-1019 + FOLFOX, Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab, Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab, Part 2D: CRPC CBP-1019 + Enzalutamide |
| OxaliplatinGiven by vein (IV) | Drug | Part 1A: Dose Escalation CBP-1019 + FOLFOX, Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab, Part 2A: Pancreatic CBP-1019 + FOLFOX, Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab |
| LeucovorinGiven by vein (IV) | Drug | Part 1A: Dose Escalation CBP-1019 + FOLFOX, Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab, Part 2A: Pancreatic CBP-1019 + FOLFOX, Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab |
| 5-FLUOROURACILGiven by vein (IV) | Drug | Part 1A: Dose Escalation CBP-1019 + FOLFOX, Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab, Part 2A: Pancreatic CBP-1019 + FOLFOX, Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab |
| BevacizumabGiven by vein (IV) | Drug | Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab, Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab |
| PembrolizumabGiven by vein (IV) | Drug | Part 1C: Dose Escalation CBP-1019 + Pembrolizumab, Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab |
| EnzalutamideGiven by mouth | Drug | Part 1D: Dose Escalation CBP-1019 + Enzalutamide, Part 2D: CRPC CBP-1019 + Enzalutamide |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 1 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Siqing Fu, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP-1019, Oxaliplatin and Leucovorin in people with Solid Tumor, run by M.D. Anderson Cancer Center at 1 site 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 40 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: looking for participants now, as of the sponsor's last update on 1 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Siqing Fu, MD,PHD ((713) 792-4318, siqingfu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 1 Sep 2026.