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

NCT06128148 | Recruiting Phase 1

• 1 other identifier: JYP0322M101
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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 .

Conditions

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

Keywords

ROS1 Fusions; ROS1 Gene Rearrangements; Primary brain tumors; ROS1

Outcome Measures

Primary Outcomes (1)

• The frequency and severity of adverse events of JYP0322

  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.

  From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.

Secondary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (7)

50 mg qd

EXPERIMENTAL

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.

Drug: JYP0322 50 mg qd

100 mg qd

EXPERIMENTAL

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.

Drug: JYP0322 100 mg qd

200 mg qd

EXPERIMENTAL

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.

Drug: JYP0322 200 mg qd

100 mg bid

EXPERIMENTAL

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.

Drug: JYP0322 100 mg bid

150 mg bid

EXPERIMENTAL

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.

Drug: JYP0322 150 mg bid

200 mg bid

EXPERIMENTAL

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.

Drug: JYP0322 200 mg bid

150 mg tid

EXPERIMENTAL

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.

Drug: JYP0322 150mg tid

Interventions

JYP0322 50 mg qd DRUG

JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

50 mg qd

JYP0322 100 mg qd DRUG

JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

100 mg qd

JYP0322 200 mg qd DRUG

JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

200 mg qd

JYP0322 100 mg bid DRUG

JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

100 mg bid

JYP0322 150 mg bid DRUG

JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

150 mg bid

JYP0322 200 mg bid DRUG

JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

200 mg bid

JYP0322 150mg tid DRUG

JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.

150 mg tid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Li Zhang, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 13, 2023
• Study Start: May 4, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)