Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2025-02-20
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
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.
SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Fulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
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.
SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Fulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
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
Interventions
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SNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Fulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pikavation Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Thomas Jefferson University-Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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SNV4818-101
Identifier Type: -
Identifier Source: org_study_id
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