SNV4818 in Participants With Advanced Solid Tumors

NCT06736704
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
320
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Lead sponsor
Pikavation Therapeutics, Inc.
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Start date
2025-02-20
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Number of sites
12
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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.
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Short title
SNV4818 in Participants With Advanced Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-06-01
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First posted
2024-12-17
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Registry last updated
2026-03-13
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Primary completion date
2027-04-01
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Start date
2025-02-20
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Participants
320
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Participant count basis
Estimated
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Planned participants
320
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Protocol amendments
3
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Number of sites
12
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Pikavation Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06736704
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ClinicalTrials.gov ID
NCT06736704
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Incidence of dose limiting toxicities (DLTs)

    Timeframe: First 28 days of study treatment

    -Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)

  2. Treatment Emergent Adverse Events (TEAEs)

    Timeframe: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose

    Incidence and frequency of TEAEs

  1. Maximum observed plasma concentration of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    Cmax

  2. Time to reach the maximum observed plasma concentration of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    Tmax

  3. Area Under Plasma Concentration (AUC) Time Curve of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    AUC0-t

  4. Half-life of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    t1/2

  5. Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity

    Timeframe: After 1 day of study treatment

    AUC0-infinity

  6. Apparent oral clearance of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    CL/F

  7. Apparent volume of distribution of SNV4818

    Timeframe: After 4 weeks (1 cycle) of study treatment

    Vz/F

  8. Overall response rate (ORR)

    Timeframe: 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

  9. Disease control rate (DCR)

    Timeframe: After 8 weeks on study treatment

    The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better

  10. Duration of response (DOR)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesRecruiting
  • Thomas Jefferson University-Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • The University of Texas M.D. Anderson Cancer CenterHouston, United StatesRecruiting
  • Chris O'Brien LifehouseCamperdown, AustraliaRecruiting
  • Scientia Clinical ResearchRandwick, AustraliaRecruiting
  • Monash HealthClayton, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • Linear Clinical ResearchNedlands, AustraliaRecruiting
  • The Ottawa Hospital Cancer CentreOttawa, CanadaRecruiting
  • University Health Network, Princess Margaret Cancer CentreToronto, CanadaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (8)