Solid Tumor Clinical Trial
— PRE-I-SPY-PIOfficial title:
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | December 30, 2027 |
Est. primary completion date | December 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ULN - Estimated Creatinine clearance (using Cockcroft-Gault formula) = 60 mL/min for small molecules and >30 mL/min for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility. These cut-off values may be modified with supporting data for specific drug regimens. - GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment. - GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository). - GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade =1 and neuropathy to grade =2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures. - GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Additional arm specific inclusion criteria as needed by drug arm regimen General Exclusion Criteria (GEC): - GEC1: Wash out periods: No other anticancer therapy within the following periods: - chemotherapy or investigational agents, 3 weeks - mitomycin C and nitrosoureas, 6 weeks - radiotherapy, 3 weeks - targeted therapy, 2 weeks - MAbs, ADCs, and immunotherapy, 3 weeks - endocrine therapy, no washout needed - GEC2: Concurrent therapy with other Investigational Products. - GEC3: Prior history of drug/regimen hypersensitivity: History of infusion-related reactions and/or hypersensitivity to IMP or excipients of the study drug/drugs which led to permanent discontinuation of the treatment. - GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements). - GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length > 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens. - GEC6: CNS tumoral spread: Active uncontrolled/symptomatic central nervous system cancer/spinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. - GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis. - GEC8: Recent major surgery within 4 weeks prior to start IMP treatment - GEC9: Pregnancy or breastfeeding - GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. - GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study. - Additional arm specific exclusion criteria as needed by drug arm regimen |
Country | Name | City | State |
---|---|---|---|
United States | The University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota |
United States | UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois |
United States | UChicago Medicine Orland Park | Orland Park | Illinois |
Lead Sponsor | Collaborator |
---|---|
QuantumLeap Healthcare Collaborative |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events related to the treatment | Evaluate the number of adverse events related to the treatment according to the current version of CTCAE during the trial. | Start of treatment to 30 days post treatment (estimated 12 -18 months) | |
Primary | Incidence of Dose Limiting Toxicities (DLTs) at each dose level | To determine the safety and tolerability of new agents/regimens in participants with certain advanced solid tumors and breast cancer. DLT rate (number of participants who experience a protocol defined DLT/total number of DLT cohort participants at that dose). | DLT observation period: Start of treatment to 21 days (Cycle 1) | |
Primary | Maximum Tolerated Dose (MTD) | The maximum dose level (mg/kg) which is not eliminated. | Start of treatment to the date of last participant at end of DLT observation period at highest dose level (estimated 6 months) | |
Primary | Recommended Phase 2 Dose (RP2D) | Using all available data, computation of RP2D (mg/kg), which may not be the MTD. | Start of treatment to the date of last participant at highest dose level (estimated 6 months) | |
Primary | Overall Response Rate (ORR) | To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer. | Start of treatment to 12 months | |
Primary | Duration of Response (DOR) | To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer. | Start of treatment to 12 months | |
Secondary | Progression Free Survival (PFS) - descriptive | To provide descriptive assessment of Progression Free Survival (PFS) of the new agents/regimens with certain advanced solid tumors and breast cancer | Start of treatment to 12 months | |
Secondary | Clinical Benefit Rate (CBR) at 6 months | To obtain preliminary Clinical Benefit Rate (CBR) at 6 months of participants treated with the new agents/regimens. | Start of treatment to 6 months |
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