PRE-I-SPY Phase I/Ib Oncology Platform Program
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
Sponsor: QuantumLeap Healthcare Collaborative
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Adverse Events related to the treatment
Time frame: Start of treatment to 30 days post treatment (estimated 12 -18 months)
Incidence of Dose Limiting Toxicities (DLTs) at each dose level
Time frame: DLT observation period: Start of treatment to 21 days (Cycle 1)
Maximum Tolerated Dose (MTD)
Time frame: Start of treatment to the date of last participant at end of DLT observation period at highest dose level (estimated 6 months)
Recommended Phase 2 Dose (RP2D)
Time frame: Start of treatment to the date of last participant at highest dose level (estimated 6 months)
Secondary Endpoints
Progression Free Survival (PFS) - descriptive
Clinical Benefit Rate (CBR) at 6 months
Eligibility Criteria
General Inclusion Criteria (GIC): * GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable). * GIC2: Age ≥ 18 years at the time of signing the informed consent * GIC3: Gender: Male or female (premenopausal and postmenopausal) * GIC4: ECOG performance status Grade 0-2 * GIC5: Estimated life expectancy \> 12 weeks at the start of investigational medicinal product (IMP) treatment. * GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP: * Absolute neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x U…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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