NCT07345637

Phase I Study of FXS887 in the Treatment of Solid Tumors

A Single-Arm, Open-Label, Dose-Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FXS887 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. FXS887 is a innovative ATR inhibitors of a class of small-molecule inhibitors targeting ATR kinase.

Detailed description

There will be two parts for this study: Phase 1a is a dose-escalation, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. Approximately 14 subjects are expected to be enrolled. Dose escalation will adopt a combination of "accelerated titration" and "3+3" design. The initial 2 dose cohorts will use the accelerated titration, while the 3+3 design will be implemented starting in other dose cohorts. If a Dose Limiting Toxicity (DLT) event or a study treatment-related adverse event of grade ≥2 occurs during the DLT observation period, the current dose cohort will switch to the 3+3 design. Eligible subjects will receive oral FXS887 once daily. The DLT observation period is within 28 days after the first dose (Cycle 1), followed by multiple-dose studies in Cycle 2 and subsequent cycles. Treatment will continue until the subject experiences disease progression, death, unacceptable toxicity, withdrawal of informed consent, or other reasons requiring discontinuation of study treatment (whichever occurs first). Phase 1b is an open-label, dose-expansion study that plans to enroll eligible patients with advanced solid tumors. The sample size will be determined based on the results of the Phase 1a, to further evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of FXS887 at the recommended expansion dose(s).

Conditions

• Solid Tumor Refractory to Conventional Treatment

Interventions

Type	Name	Description
DRUG	FXS887	FXS887 is an innovative ATR inhibitor targeting ATR kinase.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-04-28
• Completion: 2027-12-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China