Clinical trial NCT06736704: SNV4818 in Participants With Advanced Solid Tumors
Official title: A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Pikavation Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: First 28 days of study treatment
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
Secondary outcomes:
measure: Maximum observed plasma concentration of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Time to reach the maximum observed plasma concentration of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Area Under Plasma Concentration (AUC) Time Curve of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Half-life of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
timeFrame: After 1 day of study treatment
measure: Apparent oral clearance of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Apparent volume of distribution of SNV4818
timeFrame: After 4 weeks (1 cycle) of study treatment
measure: Overall response rate (ORR)
timeFrame: After 8 weeks on study treatment
measure: Disease control rate (DCR)
timeFrame: After 8 weeks on study treatment
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: W. Australia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: