A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer

Sponsor
Tianshu Liu
Study ID
NCT06363552
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SC0191 — DRUG
    The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.
  • SC0191 + Bevacizumab — DRUG
    1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle.
  • SC0191 + 5-FU/LV — DRUG
    1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days.

Study Details

The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer.

Key Dates

First listed
Apr 12, 2024
Start date
May 31, 2024
Status verified
Apr 2024
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SC0191
  • Experimental: SC0191 + Bevacizumab
  • Experimental: SC0191 + 5-FU/LV

Primary Outcome Measure

Objective Response Rate [ Time Frame: 12 months ]

Central Contacts

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