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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou JOYO Pharma Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.

Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment

Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1

Adequate organ function

Disqualifiers

Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.

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)

Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) <50%.

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

Design model

Single group

Treatments tested in this trial

  • JYP0015

    Drug

    JYP0015 is an orally bioavailable pan-RAS inhibitor designed to target the active (ON) form of wild-type and mutant RAS across KRAS, NRAS, and HRAS isoforms. The drug will be administered orally, with dosing determined by the study protocol in the dose-escalation and indication-expansion phases.

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: JYP0015 in RAS-Mutant Solid TumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-Limiting Toxicity (DLT)

The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.

Time frame
21 days
2

Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs

The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.

Time frame
Up to 3 years
3

Overall Response Rate (ORR)

Overall response rate assessed per RECIST v1.1 criteria.

Time frame
Up to 3 years

Secondary outcomes

1

Maximum Observed Blood Concentration (Cmax) of JYP0015

Maximum plasma concentration (Cmax) of JYP0015 following administration.

Time frame
Up to 16 weeks
2

Time to Reach Maximum Blood Concentration (Tmax) of JYP0015

Time to reach maximum plasma concentration (Tmax) of JYP0015 following administration.

Time frame
Up to 16 weeks
3

Duration of Response (DOR)

Duration of response as assessed by RECIST v1.1.

Time frame
Up to 3 years
4

Time to Response (TTR)

Time to response as assessed by RECIST v1.1.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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