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Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs

NCT07178613 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-17

No results posted yet for this study

Summary

This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration.

Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

Serine（Oral）

This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.

DRUG

Fluoropyrimidine Drugs

This study evaluates the dose safety and efficacy of serine in combination with fluoropyrimidine-based therapies. Primary objective: To determine the safety of oral serine administration. Secondary objectives: 1. To assess the preliminary efficacy of serine in the study population. 2. To establish the recommended Phase 2 dose for oral serine.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-02-28
Completion
2026-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178613 on ClinicalTrials.gov