Clinical Trials Directory

Trials / Unknown

UnknownNCT05278364

Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor

A Phase I/II, Open-Label, Single-arm, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of SY-5007 in Patients With RET-altered Advanced Solid Tumor.

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
184 (estimated)
Sponsor
Shouyao Holdings (Beijing) Co. LTD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a phase I/II, open-label, multi-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of SY-5007 administered orally to participants with advanced solid tumors, including RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor.

Detailed description

The study consists of 2 parts: Part 1: Dose-escalation and dose-expansion in patients with RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor. Dose-escalation study phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of SY-5007. Dose-expansion study phase is designed to evaluate the antitumor activity (ORR, DCR and DoR) of SY-5007 in patients. Part 2: Phase II study to evaluate the antitumor efficacy of SY-5007. Patients with advanced RET Fusion-Positive NSCLC will be enrolled in this phase. SY-5007 will be administered orally 160mg twice daily in a 28-day cycle. This phase is designed to determine the antitumor activity (ORR, DCR, DoR, PFS and OS), safety, and PK of SY-5007.

Conditions

Interventions

TypeNameDescription
DRUGSY-5007a RET selective Inhibitor

Timeline

Start date
2021-04-23
Primary completion
2025-01-01
Completion
2025-02-10
First posted
2022-03-14
Last updated
2023-04-12

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05278364. Inclusion in this directory is not an endorsement.