Advanced Solid Tumors
Conditions
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.
Interventions
DRUGSNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
DRUGFulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
DRUGPalbociclib
Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily
Sponsors
Pikavation Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Canada, United States
Contacts
CONTACTRobert Casper
Outcome results
None listed