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NCT Number: NCT06736704

SNV4818 in Participants With Advanced Solid Tumors

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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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Faslodex

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

Other names: Ibrance

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: First 28 days of study treatment

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

  2. Treatment Emergent Adverse Events (TEAEs)

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

    Incidence and frequency of TEAEs

Secondary outcomes

  1. Maximum observed plasma concentration of SNV4818

    Time frame: After 4 weeks (1 cycle) of study treatment

    Cmax

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

    Time frame: After 4 weeks (1 cycle) of study treatment

    Tmax

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

    Time frame: After 4 weeks (1 cycle) of study treatment

    AUC0-t

  4. Half-life of SNV4818

    Time frame: After 4 weeks (1 cycle) of study treatment

    t1/2

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

    Time frame: After 1 day of study treatment

    AUC0-infinity

  6. Apparent oral clearance of SNV4818

    Time frame: After 4 weeks (1 cycle) of study treatment

    CL/F

  7. Apparent volume of distribution of SNV4818

    Time frame: After 4 weeks (1 cycle) of study treatment

    Vz/F

  8. Overall response rate (ORR)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Casper

CONTACT

[email protected]

443-764-9527

Sponsors and collaborators

Lead sponsor

Pikavation Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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