XS-03 in Combination With FOLFOX or FOLFIRI and Bevacizumab for Treatment of Metastatic Colorectal Cancer Patients With RAS Mutation

Phase 1

Not yet recruiting

• Conditions: Colorectal Cancer; Metastatic Colorectal Cancer With RAS Mutation

• Registration Number: NCT06936527
• Lead Sponsor: NovaOnco Therapeutics Co., Ltd.

Brief Summary

XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab for treatment of metastatic colorectal cancer patients with RAS mutation

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-06-30
• Primary Completion: 2028-04-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Phase 1b: Number of participants with Dose-limiting Toxicities (DLTs) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab	up to day 28	Dose-limiting toxicities were defined as events related to XS-03 that were considered an adverse reaction or suspected adverse reaction during the first cycle of treatment
Phase 1b: Determine the Maximum Tolerated Dose (MTD) in experimental arm of XS-03 in combination with FOLFOX or FOLFIRI and Bevacizumab	up to day 28	MTD is defined as at most 1 patient out of 6 experiencing DLT
Phase 2: Objective Response Rate (ORR) of two experimental arms and comparator arm	up to 18 months after first dose of last patient	Defined as the percentage of participants that achieve a best overall response of complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR) of all treated participants	up to 18 months after first dose of last patient	Duration of response defined as time from when response was first documented until first documented disease progression or death, whichever occurs first.
Overall survival (OS) of treated participants	up to 18 months after first dose of last patient	Time in months from date of first dose for phase 1b and randomization for phase 2 to death due to any cause
Number of Participants With Clinically Significant Change From Baseline in safety monitoring	up to 28 days after last dose of study drug
Number of Participants With dose adjustment	up to 28 days after last dose of study drug	AE associated with dose reduction, interruption and discontinuation
Area under the plasma concentration versus time curve from time zero to the last measurable concentration(AUC0-t)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Elimination Half-life (T1/2)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
The volume of distribution(Vd/F)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Progression-free survival (PFS) of treated participants	up to 18 months after first dose of last patient	as determined based on RECIST version 1.1 criteria
Average concentration at steady state(Cavg,ss)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Minimum observed concentration at steady state(Cmin,ss)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Number of Participants With Adverse Events (AEs) of treated participants	up to 28 days after last dose of study drug	The severity of each AE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Maximum Plasma Concentration(Cmax)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Time to Reach Maximum Peak Plasma Concentration (Tmax)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Systemic Clearance From Plasma Following Extravascular Administration (CL/F)	From pre-dose on day 1 of cycle 1 to day 5 of cycle 3 (28-day cycle length)	Pharmacokinetic parameter
Phase 1b: Objective Response Rate (ORR) of all treated participants	up to 18 months after first dose of last patient

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China