Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS (STAR)

Guangzhou JOYO Pharma

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer (NSCLC); Solid Tumor; Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments: Drug: JYP0015

Study type: Interventional

Funder types: Industry

Identifiers

NCT06895031

JYP0015M101

Details and patient eligibility

About

Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.

Full description

This is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of JYP0015 in adult patients with advanced solid tumors harboring specific RAS mutations.

The study consists of two parts:

• Phase 1 (dose escalation) - Evaluates the safety, tolerability, and pharmacokinetic profile of JYP0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (RD) for further evaluation.

• Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts:

  1. Pancreatic ductal adenocarcinoma (PDAC)
  2. Non-small cell lung cancer (NSCLC)
  3. Colorectal cancer (CRC)
  4. Other advanced solid tumors Phase 2 will assess both efficacy and safety within these cohorts.

JYP0015 is a potent, orally bioavailable pan-RAS inhibitor that selectively targets the active (ON) form of wild-type and mutant RAS across all three isoforms-HRAS, NRAS, and KRAS.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
2. Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
4. Adequate organ function

Exclusion criteria

1. Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
2. Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets， Malabsorption syndrome，Refractory nausea, vomiting, or diarrhea，Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis)
3. Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%.
4. Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse，Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， Familial or social circumstances that may affect patient safety, compliance, or study data collection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

JYP0015 in RAS-Mutant Solid Tumors

Experimental group

Description:

This arm includes participants with histologically or pathologically confirmed advanced solid tumors harboring RAS mutations, identified via molecular testing. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, 61, 117, or 146 (e.g., G12, G13, Q61, K117, or A146). Participants will receive JYP0015 as an oral tablet.

Treatment:

Drug: JYP0015