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

Guangzhou JOYO Pharma

Status and phase: Enrolling; Phase 1

Conditions: Lung Neoplasms; Other Protocol Specified Criteria; Protein Kinase Inhibitors; Brain Neoplasms

Treatments: Drug: JYP0322 200 mg bid; Drug: JYP0322 100 mg qd; Drug: JYP0322 200 mg qd; Drug: JYP0322 150mg tid; Drug: JYP0322 50 mg qd; Drug: JYP0322 150 mg bid; Drug: JYP0322 100 mg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06128148

JYP0322M101

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 101 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Adult patients age 18 years or older.
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.
• Measurable disease according to RECIST version 1.1
• Life expectancy of at least 3 months
• Other protocol specified criteria

Key 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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101 participants in 7 patient groups

50 mg qd

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 50 mg qd

100 mg qd

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 100 mg qd

200 mg qd

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 200 mg qd

100 mg bid

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 100 mg bid

150 mg bid

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 150 mg bid

200 mg bid

Experimental group

Description:

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.

Treatment:

Drug: JYP0322 200 mg bid

150 mg tid

Experimental group

Description:

Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg tid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.

Treatment:

Drug: JYP0322 150mg tid