Recruiting NCT06736704
SNV4818 in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNV4818, Fulvestrant, Palbociclib.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors
Overview
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
- Drug SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm. - Drug Fulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections) - Drug Palbociclib
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
Primary outcome measures
- Incidence of dose limiting toxicities (DLTs) [Time frame: First 28 days of study treatment]
- Treatment Emergent Adverse Events (TEAEs) [Time frame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose]
Secondary outcome measures (10)
- Maximum observed plasma concentration of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Time to reach the maximum observed plasma concentration of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Area Under Plasma Concentration (AUC) Time Curve of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Half-life of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity [Time frame: After 1 day of study treatment]
- Apparent oral clearance of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Apparent volume of distribution of SNV4818 [Time frame: After 4 weeks (1 cycle) of study treatment]
- Overall response rate (ORR) [Time frame: After 8 weeks on study treatment]
- Disease control rate (DCR) [Time frame: After 8 weeks on study treatment]
- Duration of response (DOR) [Time frame: Up to approximately 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate — Los Angeles
- Massachusetts General Hospital — Boston
- Thomas Jefferson University-Sidney Kimmel Cancer Center — Philadelphia
- Sarah Cannon Research Institute — Nashville
- The University of Texas M.D. Anderson Cancer Center — Houston
Australia · 5 centers
- Chris O'Brien Lifehouse — Camperdown
- Scientia Clinical Research — Randwick
- Monash Health — Clayton
- Peter MacCallum Cancer Centre — Melbourne
- Linear Clinical Research — Nedlands
Canada · 2 centers
- The Ottawa Hospital Cancer Centre — Ottawa
- University Health Network, Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06736704 · SNV4818-101