Metastatic Colorectal AdenocarcinomaPhase 1NCT06336902
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
A Phase 1 study testing Balstilimab, Biospecimen Collection and Botensilimab in people with Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v8, run by University of Southern California at 3 sites in United States.
Trial summary
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
- What is being tested?
- Balstilimab, Biospecimen Collection and Botensilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2025to 15 Jan 2028
- 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
- Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act [CLIA]-certified lab), including metastases to liver, lung, etc.
- Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan
- ≥ 18 years of age
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Estimated life expectancy ≥ 3 months
- Body mass index (BMI) ≥ 18.5
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- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 8.0 g/dL
- Platelets ≥ 75,000/mcL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (for patients with Gilbert syndrome ≤ 3.0 x ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN
- Creatinine ≤ 1.5 x ULN
- Measurable disease as defined by RECIST 1.1
- No history of prior or current malignancy that requires active treatment
- Female patients of childbearing potential must be willing to use highly effective contraceptive measures starting with the Screening visit through 90 days after last dose of study treatment.
- Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
- Female patients of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:
- ≥ 45 years of age and has not had menses for > 1 year
- Amenorrheic for > 2 years without a hysterectomy and/or oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
- Status is post-hysterectomy, -oophorectomy, or -tubal ligation
- Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
- Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
Who cannot join
- Patients with a current diagnosis of diabetes mellitus are not eligible for this study.
- Note: Patients with pre-diabetes or previous diabetes or glucose intolerance and who are currently not taking any diabetes medications are eligible
- Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible for this study
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease, with approval from the principal investigator
- History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous
- Current use of oral vitamin C supplements
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- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of current study drug
- Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)
- History of anti-PD1 or anti-CTLA4 therapy
- Unresolved toxicity ≥ CTCAE grade 2 except for neuropathy, alopecia
- Untreated brain or leptomeningeal metastases or previously treated CNS metastases with any of the following: residual neurologic deficit; history of seizures; ongoing requirement of steroids, exceeding prednisone 10 mg daily dose
- Patients who have uncontrolled or severe hyponatremia, hypernatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
- Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis
- Patients who have a history of oxalate renal calculi
- Major surgery within 4 weeks of first dose of immunotherapy
- Known severe (grade ≥ 3) hypersensitivity reactions to fully human monoclonal antibodies, antibody, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids; or has a history of interstitial lung disease, any history of anaphylaxis, or uncontrolled asthma
- Evidence of bleeding diathesis or clinically significant coagulopathy
- Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.
- Note: Corticosteroid use as a premedication for IV contrast allergies/reactions is allowed. Patients who are receiving daily corticosteroid replacement therapy are also an exception to this rule. Daily prednisone at doses of ≤ 10 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy. Use of inhaled or topical corticosteroid is permitted
- Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible
- Has had an allogeneic tissue/solid organ transplant, except for corneal transplants
- Legally incapacitated or has limited legal capacity
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active coronary artery disease, myocardial infarction or cerebrovascular accident within 6 months prior to study entry, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Saint Jude Medical Center / Providence Medical Foundation
Fullerton, California, 92835
Maria Diosdado, 714-446-5615, Maria.Diosdado@providence.org
David Park, MD
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Charlean Ketchens, RN, 323-865-0451, Charlean.Ketchens@med.usc.edu
Rabia Rehman, 323-865-0451, Rabia.Rehman@med.usc.edu
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Charlean Ketchens, RN, 323-865-0451, Charlean.Ketchens@med.usc.edu
Rabia Rehman, 323-865-0451, Rabia.Rehman@med.usc.edu
About this study
Official title: A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of the fasting mimicking diet (FMD) when combined with vitamin C and botensilimab plus balstilimab by determining the proportion of patients who adhere to the FMD ≥ 75% of the designated days and receive all doses of botensilimab, balstilimab and Vitamin C for at least any two cycles of therapy.
II. To characterize the safety and tolerability of FMD and vitamin C when combined with botensilimab and balstilimab by assessing any grade toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
SECONDARY OBJECTIVES:
- To obtain a preliminary assessment of anti-tumor activity of botensilimab plus balstilimab and FMD plus vitamin C by determining the overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To estimate the progression-free and overall survival in patients with KRAS-mutant colorectal cancer (CRC) receiving botensilimab plus balstilimab and FMD plus vitamin C.
EXPLORATORY OBJECTIVES:
- To characterize circulating tumor deoxyribonucleic acid (ctDNA) and ctDNA methylation (TET, Wnt, JAK/STAT, PI3K/AKT, CXCR, ALDH, AMPK) profiles at baseline, on treatment and at disease progression.
II. To examine metabolomic markers (IGF-1, GAPDH, DHA, GLUT-1, iron signaling) at baseline, on treatment and at disease progression.
OUTLINE:
Patients receive botensilimab intravenously (IV) over 30 minutes on day 1 of each cycle for up to 4 cycles. Patients receive balstilimab IV over 30 minutes and vitamin C IV over 30 minutes on days 1, 15 and 29 of each cycle. Patients undergo a FMD on days -4 to -1 of each cycle. Cycles repeat every 42 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, computed tomography (CT) scans and magnetic resonance imaging (MRI) throughout the study.
After completion of study intervention, patients are followed up at 30 days and every 3 months for up to 6 months.
- Being tested
- Balstilimab, Biospecimen Collection, Botensilimab, Computed Tomography, Dietary Intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalstilimabBiological
Also called AGEN 2034, AGEN-2034, AGEN2034
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
BotensilimabBiological
Also called AGEN 1181, AGEN-1181, AGEN1181, Anti-CTLA-4 Monoclonal Antibody AGEN1181
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Undergo FMD
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Vitamin CDietary supplement
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (botensilimab, balstilimab, FMD, vitamin C) | Experimental | Patients receive botensilimab IV over 30 minutes on day 1 of each cycle for up to 4 cycles. Patients receive balstilimab IV over 30 minutes and vitamin C IV over 30 minutes on days 1, 15 and 29 of each cycle. Patients undergo a FMD on days -4 to -1 of each cycle. Cycles repeat every 42 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT scans and MRI throughout the study. Receives: Biological: Balstilimab; Procedure: Biospecimen Collection; Biological: Botensilimab; Procedure: Computed Tomography; Other: Dietary Intervention; Procedure: Magnetic Resonance Imaging; Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who adhere to the fast mimicking diet
Adherence will be defined as the percentage of patients who adhere to the fasting-mimicking diet ≥ 75% of the designated days and receive all doses of study drugs for at least any 2 cycles of therapy during the course of the study. Adherence will be reported overall and by cycle started.
Measured: Up to 30 months
Incidence of adverse events (AEs)
The frequency and severity of treatment-related events will be assessed using Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize AEs including counts for categorical measures and means for continuous measures. Incidence of AEs will be reported overall and by cycle started.
Measured: Up to 30 months
Secondary outcomes (3)
Overall response rate (ORR)
ORR will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Up to 30 months
Progression-free survival (PFS)
Measured from start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS Progression will be evaluated using RECIST v1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Measured: Up to 30 months
Overall survival (OS)
Measured from start of treatment until death from any cause. Patients who are still alive at the time of the analysis, or who have become lost to follow-up or withdrawn consent will be censored at their last date known to be alive.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Diana Hanna, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336902
- Sponsor's protocol ID
- 3C-23-11
- Other IDs
- NCI-2024-01368, 3C-23-11, P30CA014089
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2024
- Last updated
- 17 Mar 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06336902
- Acronym / sponsor ID
- 3C-23-11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 29 Mar 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.
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of the fasting mimicking diet (FMD) when combined with vitamin C and botensilimab plus balstilimab by determining the proportion of patients who adhere to the FMD ≥ 75% of the designated days and receive all doses of botensilimab, balstilimab and Vitamin C for at least any two cycles of therapy.
II. To characterize the safety and tolerability of FMD and vitamin C when combined with botensilimab and balstilimab by assessing any grade toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
SECONDARY OBJECTIVES:
- To obtain a preliminary assessment of anti-tumor activity of botensilimab plus balstilimab and FMD plus vitamin C by determining the overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To estimate the progression-free and overall survival in patients with KRAS-mutant colorectal cancer (CRC) receiving botensilimab plus balstilimab and FMD plus vitamin C.
EXPLORATORY OBJECTIVES:
- To characterize circulating tumor deoxyribonucleic acid (ctDNA) and ctDNA methylation (TET, Wnt, JAK/STAT, PI3K/AKT, CXCR, ALDH, AMPK) profiles at baseline, on treatment and at disease progression.
II. To examine metabolomic markers (IGF-1, GAPDH, DHA, GLUT-1, iron signaling) at baseline, on treatment and at disease progression.
OUTLINE:
Patients receive botensilimab intravenously (IV) over 30 minutes on day 1 of each cycle for up to 4 cycles. Patients receive balstilimab IV over 30 minutes and vitamin C IV over 30 minutes on days 1, 15 and 29 of each cycle. Patients undergo a FMD on days -4 to -1 of each cycle. Cycles repeat every 42 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, computed tomography (CT) scans and magnetic resonance imaging (MRI) throughout the study.
After completion of study intervention, patients are followed up at 30 days and every 3 months for up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (botensilimab, balstilimab, FMD, vitamin C) | Experimental | Biological: Balstilimab, Procedure: Biospecimen Collection, Biological: Botensilimab, Procedure: Computed Tomography, Other: Dietary Intervention, Procedure: Magnetic Resonance Imaging, Dietary Supplement: Vitamin CPatients receive botensilimab IV over 30 minutes on day 1 of each cycle for up to 4 cycles. Patients receive balstilimab IV over 30 minutes and vitamin C IV over 30 minutes on days 1, 15 and 29 of each cycle. Patients undergo a FMD on days -4 to -1 of each cycle. Cycles repeat every 42 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT scans and MRI throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act [CLIA]-certified lab), including metastases to liver, lung, etc.
- Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan
- ≥ 18 years of age
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Estimated life expectancy ≥ 3 months
Key exclusion criteria (24 listed)
- Patients with a current diagnosis of diabetes mellitus are not eligible for this study.
- Note: Patients with pre-diabetes or previous diabetes or glucose intolerance and who are currently not taking any diabetes medications are eligible
- Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible for this study
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease, with approval from the principal investigator
- History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous
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 |
|---|---|---|
| BalstilimabAlso: AGEN 2034, AGEN-2034, AGEN2034Given IV | Biological | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| BotensilimabAlso: AGEN 1181, AGEN-1181, AGEN1181, Anti-CTLA-4 Monoclonal Antibody AGEN1181Given IV | Biological | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsUndergo FMD | Other | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
| Vitamin CGiven IV | Dietary supplement | Treatment (botensilimab, balstilimab, FMD, vitamin C) |
Primary outcome
Proportion of patients who adhere to the fast mimicking diet
Time frame: Up to 30 months
Adherence will be defined as the percentage of patients who adhere to the fasting-mimicking diet ≥ 75% of the designated days and receive all doses of study drugs for at least any 2 cycles of therapy during the course of the study. Adherence will be reported overall and by cycle started.
Incidence of adverse events (AEs)
Time frame: Up to 30 months
The frequency and severity of treatment-related events will be assessed using Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize AEs including counts for categorical measures and means for continuous measures. Incidence of AEs will be reported overall and by cycle started.
3 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 30 months
Progression-free survival (PFS)
Time frame: Up to 30 months
Overall survival (OS)
Time frame: Up to 30 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 17 Mar 2026.
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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.
Diana Hanna, MD principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Balstilimab, Biospecimen Collection and Botensilimab in people with Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v8, run by University of Southern California at 3 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 22 inclusion and 24 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 Charlean Ketchens, RN (323-865-0451, Charlean.Ketchens@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who adhere to the fast mimicking diet (time frame: Up to 30 months). The study lists 2 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 17 Mar 2026.