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

NCT07178613 | Not Yet Recruiting Phase 1

• 1 other identifier: EC-2025-19
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety of Oral Serine

  Assess the safety of oral serine, including the occurrence of adverse events and dose - limiting toxicities

  Up to 28 days

Study Arms (1)

Serine + Fluoropyrimidine Group

OTHER

Drug: Serine（Oral）; Drug: Fluoropyrimidine Drugs

Interventions

Serine（Oral） DRUG

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.

Serine + Fluoropyrimidine Group

Fluoropyrimidine Drugs DRUG

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.

Serine + Fluoropyrimidine Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years (inclusive), male or female;
• Patients with advanced colorectal cancer confirmed by histopathological or cytological examination, eligible for standard first-line treatment with fluorouracil-containing regimens.
• Patients must have at least one measurable lesion.
• ECOG performance status ≤ 2.
• Expected survival ≥ 3 months;
• Major organ functions are essentially normal, with laboratory tests meeting the following criteria:
• Hematology (no transfusion of blood or blood products within 7 days prior to testing; no use of G-CSF or other hematopoietic growth factors for correction):
• Absolute neutrophil count ≥1.5×10⁹/L ; Platelets ≥75×10⁹/L ; Hemoglobin ≥90 g/L;
• Renal:
• Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73 m² (Cockcroft-Gault formula);
• Liver:
• Serum total bilirubin \<1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5×ULN or ≤5×ULN (for subjects with liver metastases); Albumin (ALB) ≥30 g/L;
• Coagulation Function:
• International Normalized Ratio (INR) or Prothrombin Time (PT) \< 1.5×ULN. If the subject is receiving anticoagulant therapy, PT is acceptable as long as it falls within the therapeutic range for the anticoagulant drug.
• Cardiovascular System:

You may not qualify if:

• Trial Participation Restrictions: Currently participating in or having received investigational drug/device treatment within the past 4 weeks;
• Prior Fluorouracil-Based Therapy Restrictions: History of ≥Grade 3 toxicity (e.g., myelosuppression, gastrointestinal toxicity) following prior fluorouracil-based therapy, deemed unsuitable for re-administration by the investigator;
• Recent Surgery Restriction: Undergone major surgery (excluding diagnostic biopsy) within 28 days prior to first dosing, or scheduled for surgery during the study period;
• Metabolic and Nutritional Status Restriction: Presence of severe malnutrition (BMI \< 18.5 or serum albumin \< 30 g/L), or inability to supplement serine orally (e.g., malabsorption syndrome, short bowel syndrome); Known serine metabolism disorders (e.g., PHGDH/PSAT1 gene mutation-related diseases);
• Concurrent severe disease restrictions: Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, uncontrolled hypertension \>150/100 mmHg); severe respiratory disease (COPD, GOLD Stage ≥3, interstitial lung disease); Active infection (requiring systemic antibiotic/antiviral therapy);
• Active HIV/viral hepatitis: HIV-positive status, or active hepatitis B (HBV-DNA ≥ 2000 IU/mL), or active hepatitis C (HCV-RNA positive); (Note: Patients with HBV-DNA \< 2000 IU/mL receiving antiviral therapy may be enrolled);
• Neurological disorders: Uncontrolled brain metastases (with intracranial hypertension or neurological symptoms), or history of severe psychiatric illness/substance abuse (impeding treatment compliance);
• Allergy history: Known allergy to fluorouracil-based drugs or serine supplements;
• Pregnancy/lactation: Pregnant or lactating women (patients of childbearing potential must use highly effective contraception);
• Other conditions deemed ineligible by the investigator: Any concomitant conditions or laboratory abnormalities that may interfere with study results, increase risk, or compromise patient safety.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09