A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

NCT07582003 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT2026-09-Gong-SAMeCRC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll a total of 18 patients who have undergone curative surgery for stage I or II colorectal cancer and are planned for post-surgical surveillance without any need for chemotherapy at Cedars-Sinai Medical Center. All subjects will receive an oral daily supplement called S-Adenosylmethionine (SAMe) which has been hypothesized to reduce colorectal polyps (precursors to colorectal cancer) and prevent colorectal cancer formation. The study investigates what the appropriate dosage of SAMe is so that there is the lowest risk of side effects, and whether the supplement will prevent polyp formation in a population of patients who at risk for developing polyps and colorectal cancer. The primary endpoint will be to determine the recommended phase II dose (RP2D), the highest safe dose of SAMe that could be studied in larger clinical trials to advance this agent further in clinical development. Secondary endpoints include safety, the rate of postoperative adenomas detected on surveillance colonoscopy, and the effects of SAMe on the colon, specifically, its impact on gut bacteria and tissue markers before and after SAMe treatment to better understand the mechanisms to how SAMe may have its colorectal cancer preventive effects.

Conditions

Colorectal Cancer (Diagnosis); Adenoma

Keywords

Adenoma; Colorectal Cancer; S-Adenosylmethionine (SAMe)

Outcome Measures

Primary Outcomes (1)

• Recommended Phase II Dose (RP2D)

  The RP2D will be defined as the dose level closest to the median of the marginal posterior distribution of the of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of a dose-limiting toxicity at the MTD is θ=0.33.

  4 weeks post study treatment

Secondary Outcomes (2)

• Rate of Adenomas

  Post treatment, roughly 1 year

• Safety by Adverse Events

  Post treatment, roughly 1 year

Study Arms (1)

S-Adenosylmethionine (SAMe)

EXPERIMENTAL

Drug: S-Adenosylmethionine (SAMe)

Interventions

S-Adenosylmethionine (SAMe) DRUG

S-Adenosylmethionine (SAMe) will be given at an oral daily dose of 1600-2400 mg daily divided into 400 mg tablets in the morning before breakfast and in the evening before dinner to constitute the total daily dose.

S-Adenosylmethionine (SAMe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Adults ≥18 years old with histologically confirmed, curatively resected stage I-II colorectal cancer; 2) must agree to pre-intervention (baseline) stool sample and distal colon biopsy; 3) must start study intervention within 30 days ±7 days of the baseline biopsy; 4) must be able to complete up to 12 months of intervention prior to planned postoperative surveillance colonoscopy within 1 year of surgery; 5) must undergo repeat stool sample and distal colon biopsy within 7 days ±4 days of the last dose of study intervention; 6) did not receive adjuvant therapy; 7) not currently breastfeeding or pregnant.

You may not qualify if:

• \) Have a history familial adenomatous polyposis (FAP); 2) have a history of hereditary nonpolyposis colorectal cancer; 3) history of inflammatory bowel disease; 4) high-dose aspirin (except for low-dose (≤100 mg/day) aspirin for cardiovascular prevention) within the past 60 days of enrollment.

Sponsors & Collaborators

• Jun Gong, MD: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Disease; Adenoma

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jun Gong, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Recruitment

CONTACT

310-423-3713; GroupCancerTrialInformation@cshs.org

Jun Gong, MD

CONTACT

jun.gong@csmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)