SNV4818 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pikavation Therapeutics, Inc.
Study ID
NCT06736704
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNV4818 — DRUG
    SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
  • Fulvestrant — DRUG
    Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
  • Palbociclib — DRUG
    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

Study Details

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.

Key Dates

Start date
Feb 20, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SNV4818 Monotherapy
    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.
  • Experimental: SNV4818+Fulvestrant Combination
    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.
  • Experimental: SNV4818+Palbociclib+Fulvestrant Combination
    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.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: First 28 days of study treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos AngelesCalifornia90025-
Massachusetts General HospitalBostonMassachusetts02114-
Thomas Jefferson University-Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Sarah Cannon Research InstituteNashvilleTennessee37203-
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate· Los Angeles, CAMassachusetts General Hospital· Boston, MAThomas Jefferson University-Sidney Kimmel Cancer Center· Philadelphia, PASarah Cannon Research Institute· Nashville, TNThe University of Texas M.D. Anderson Cancer Center· Houston, TX

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