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

NCT06128148 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

DRUG

JYP0322 50 mg qd

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

DRUG

JYP0322 100 mg qd

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

DRUG

JYP0322 200 mg qd

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

DRUG

JYP0322 100 mg bid

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

DRUG

JYP0322 150 mg bid

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

DRUG

JYP0322 200 mg bid

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

DRUG

JYP0322 150mg tid

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

Sponsors & Collaborators

  • Guangzhou JOYO Pharma Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Li Zhang, M.D. · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2026-06-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128148 on ClinicalTrials.gov