Is NCT06336902 recruiting in Fullerton, CA?

Yes, NCT06336902 is currently recruiting participants at its Fullerton, CA location. This metastatic colorectal adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Fullerton clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Colorectal Adenocarcinoma Clinical Trial in Fullerton, CA

Q: How do I join the metastatic colorectal adenocarcinoma clinical trial in Fullerton?

To join this clinical trial in Fullerton, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Metastatic Colorectal Adenocarcinoma Study in Fullerton

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.

Sponsor: University of Southern California

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fullerton?

Yes, this clinical trial (NCT06336902) has an active research site in Fullerton, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Colorectal Adenocarcinoma Treatment Options in Fullerton, CA

If you're searching for metastatic colorectal adenocarcinoma treatment options in Fullerton, CA, this clinical trial (NCT06336902) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fullerton research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic colorectal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic colorectal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Colorectal Adenocarcinoma Clinical Trial in Fullerton, CA

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