SNV4818 in Participants with Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SNV4818; Drug: Fulvestrant

• Registration Number: NCT06736704
• Lead Sponsor: Synnovation Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SNV4818+Fulvestrant Combination	SNV4818	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.
SNV4818 Monotherapy	SNV4818	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.
SNV4818+Fulvestrant Combination	Fulvestrant	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.

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicities (DLTs)	First 28 days of study treatment	-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Treatment Emergent Adverse Events (TEAEs)	From first SNV4818 dose through approximately 30 days following the last SNV4818 dose	Incidence and frequency of TEAEs

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration of SNV4818	After 4 weeks (1 cycle) of study treatment	Cmax
Time to reach the maximum observed plasma concentration of SNV4818	After 4 weeks (1 cycle) of study treatment	Tmax
Area Under Plasma Concentration (AUC) Time Curve of SNV4818	After 4 weeks (1 cycle) of study treatment	AUC0-t
Half-life of SNV4818	After 4 weeks (1 cycle) of study treatment	t1/2
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity	After 1 day of study treatment	AUC0-infinity
Apparent oral clearance of SNV4818	After 4 weeks (1 cycle) of study treatment	CL/F
Apparent volume of distribution of SNV4818	After 4 weeks (1 cycle) of study treatment	Vz/F
Overall response rate (ORR)	After 8 weeks on study treatment	The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
Disease control rate (DCR)	After 8 weeks on study treatment	The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better
Duration of response (DOR)	Up to approximately 2 years	The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.

Trial Locations

Locations (1)

The University of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States