SNV4818 in Participants With Advanced Solid Tumors

Pikavation Therapeutics, Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SNV4818; Drug: Palbociclib; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06736704

SNV4818-101

Details and patient eligibility

About

This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or metastatic solid tumor with an activating PIK3CA mutation.
• Refractory to or intolerant of available therapies
• Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

• Diagnosis of a primary CNS malignancy
• Active brain metastases or carcinomatous meningitis
• Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
• Inadequate organ function
• Clinically significant ECG abnormalities, including QTcF ≥ 470 ms

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 3 patient groups

SNV4818 Monotherapy

Experimental group

Description:

Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

Treatment:

Drug: SNV4818

SNV4818+Fulvestrant Combination

Experimental group

Description:

Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

Treatment:

Drug: Fulvestrant

Drug: SNV4818

SNV4818+Palbociclib+Fulvestrant Combination

Experimental group

Description:

Participants will receive oral, daily doses of SNV4818 in combination with a standard doses of Palbociclib and Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

Treatment:

Drug: Fulvestrant

Drug: SNV4818

Drug: Palbociclib