Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

Phase 1

Recruiting

• Conditions: Protein Kinase Inhibitors; Other Protocol Specified Criteria; Lung Neoplasms; Brain Neoplasms
• Interventions: Drug: JYP0322 50 mg qd; Drug: JYP0322 100 mg qd; Drug: JYP0322 200 mg qd; Drug: JYP0322 100 mg bid; Drug: JYP0322 150 mg bid; Drug: JYP0322 200 mg bid

• Registration Number: NCT06128148
• Lead Sponsor: Guangzhou JOYO Pharma Co., Ltd

Brief Summary

An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .

Detailed Description

JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.

Study Timeline

• Study Start: 2022-05-04
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Status Verified: 2024-11
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

• Current participation in another therapeutic clinical trial.
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
• A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
• Known active infections (bacterial, viral including HIV positivity).
• Other protocol specified criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50 mg qd	JYP0322 50 mg qd	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 50 mg qd. This arm evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of this dose level.
100 mg qd	JYP0322 100 mg qd	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg qd. This arm assesses safety, tolerability, and pharmacokinetics (PK) data for this dose level.
200 mg qd	JYP0322 200 mg qd	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg qd. This arm examines the safety, pharmacokinetics (PK), and preliminary efficacy of this dose level.
100 mg bid	JYP0322 100 mg bid	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg bid. The arm evaluates the safety, tolerability, and pharmacokinetics (PK) of this increased dosing frequency.
150 mg bid	JYP0322 150 mg bid	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg bid. This arm aims to determine the optimal dosing for safety, pharmacokinetics (PK), and efficacy.
200 mg bid	JYP0322 200 mg bid	Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg bid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.

Primary Outcome Measures

Name	Time	Method
The frequency and severity of adverse events of JYP0322	From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.	Evaluate the safety and tolerability of JYP0322 treatment. This will be assessed by: Incidence, nature, and severity of adverse events (AEs) during treatment, the proportion of patients requiring dose adjustment or permanent drug discontinuation.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.	ORR is the proportion of subjects with CR or PR , based on RECIST v1.1 criteria.
Disease Control Rate (DCR)	From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.	DCR is the proportion of subjects with CR or PR or SD, based on RECIST v1.1 criteria.
Duration of Response (DOR)	From the date of first response until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.	The time from the first documented objective response to the first occurrence of tumor progression or death from any cause.
Time to Response (TTR)	From the first dose of study drug to the date of first objective response, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.	The time from treatment initiation to the first documented objective response.
Progression-Free Survival (PFS)	From the first dose of study drug until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.	The time from initiation of JYP0322 treatment to tumor progression or death from any cause.

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China