NCT06128148 (JYP0322) is a Phase 1 clinical trial of JYP0322 50 mg qd in Protein Kinase Inhibitors, sponsored by Guangzhou JOYO Pharma Co., Ltd.

Who is sponsoring NCT06128148?

NCT06128148 is sponsored by Guangzhou JOYO Pharma Co., Ltd.

What drugs are being tested in NCT06128148?

Interventions in NCT06128148: JYP0322 50 mg qd, JYP0322 100 mg qd, JYP0322 200 mg qd, JYP0322 100 mg bid, JYP0322 150 mg bid, JYP0322 200 mg bid, JYP0322 150mg tid.

What condition does NCT06128148 study?

NCT06128148 studies Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms.

Is NCT06128148 still recruiting?

NCT06128148 is currently recruiting now. Last updated 14 July 2025.

Last reviewed 2025-07-14 · How we verify

NCT06128148: JYP0322

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 14 July 2025

What this trial tests

Phase 1 trial testing JYP0322 50 mg qd in Protein Kinase Inhibitors in 101 participants. Currently enrolling.

Timeline

4 May 2022

Primary endpoint
30 June 2026

30 December 2027

Quick facts

Lead sponsor	Guangzhou JOYO Pharma Co., Ltd
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	4 May 2022
Primary completion	30 June 2026
Estimated completion	30 December 2027
Sites	1 location across China

Drugs / interventions tested

JYP0322 50 mg qd
JYP0322 100 mg qd — full drug profile →
JYP0322 200 mg qd — full drug profile →
JYP0322 100 mg bid
JYP0322 150 mg bid — full drug profile →
JYP0322 200 mg bid — full drug profile →
JYP0322 150mg tid — full drug profile →

Conditions studied

Protein Kinase Inhibitors — all drugs for Protein Kinase Inhibitors →
Other Protocol Specified Criteria — all drugs for Other Protocol Specified Criteria →
Lung Neoplasms — all drugs for Lung Neoplasms →
Brain Neoplasms — all drugs for Brain Neoplasms →

Sponsor

Guangzhou JOYO Pharma Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Protein Kinase Inhibitors or Other Protocol Specified Criteria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 .

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer brain metastasis: molecular mechanisms and therapeutic strategies.
Lu Y, Huang Y, Zhu C, Li Z, et al · · 2025 · cited 9× · PMID 39998776 · DOI 10.1186/s43556-025-00251-0
JYP0322, a highly selective and brain-penetrant ROS1 inhibitor, overcomes ROS1<sup>G2032R</sup> resistance mutation in NSCLC: The first-in-human phase 1 trial.
Ma Y, Xue J, Gao F, Yang Y, et al · · 2026 · PMID 42030931 · DOI 10.1016/j.ccell.2026.03.018
Diversity and function of tumor-associated macrophages in brain metastases: mechanisms and therapeutic prospects.
Ma Y, Wang H, Dou X, Li Q. · · 2026 · PMID 41727473 · DOI 10.3389/fimmu.2026.1756299
Evolving Therapeutic Landscape of ROS1-Positive Non-Small Cell Lung Cancer: An Updated Review.
Bischoff H, Gendarme S, Somme L, Chouaid C, et al · · 2025 · PMID 41294688 · DOI 10.3390/curroncol32110626
The global landscape of clinical trials and drug discovery for brain metastasis.
Ding J, Jiang Y, Zhou J, Tang Q, et al · · 2024 · PMID 39107814 · DOI 10.1186/s12967-024-05310-8

Verify or expand the search:

Other recruiting trials for Protein Kinase Inhibitors

Currently open trials in the same condition.

NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT03091192 — Savolitinib vs. Sunitinib in MET-driven PRCC. · Phase 3 · active not recruiting

Other Guangzhou JOYO Pharma Co., Ltd trials

Trials by the same sponsor.

NCT07154368 — JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs. · Phase 3 · not yet recruiting
NCT06895031 — Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS · Phase 2 · recruiting
NCT06158490 — A Study to Evaluate JYP0061 Tablets in Patients With Moderate-to-severe Atopic Dermatitis · Phase 2 · enrolling by invitation
NCT06125327 — SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2, PHASE3 · recruiting
NCT06697535 — A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD) · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06128148 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Guangzhou JOYO Pharma Co., Ltd
Last refreshed: 14 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06128148.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing