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.
The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The trial allows for various study arm designs, with the goal to complete analysis of a study arm in 12 to 18 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
CD47 Inhibitor: A fusion protein containing a high affinity engineered D1 domain of human signal regulatory protein alpha (SIRPα) variant 1 (v1) genetically linked to a modified and inactive Fc domain of human immunoglobulin (Ig) G1.
Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor
Bispecific HER2 antibody: A humanized, bispecific, immunoglobulin G isotype 1 (IgG1)-like antibody directed against the juxtamembrane extracellular domain (ECD4) and the dimerization domain (ECD2) of human epidermal growth factor receptor 2 (HER2).
Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).
The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGThe University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGUChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
RECRUITINGUChicago Medicine Orland Park
Orland Park, Illinois, United States
RECRUITINGUniversity of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGIncidence 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.
Time frame: Start of treatment to 30 days post treatment (estimated 12 -18 months)
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).
Time frame: DLT observation period: Start of treatment to 21 days (Cycle 1)
Maximum Tolerated Dose (MTD)
The maximum dose level (mg/kg) which is not eliminated.
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)
Using all available data, computation of RP2D (mg/kg), which may not be the MTD.
Time frame: Start of treatment to the date of last participant at highest dose level (estimated 6 months)
Overall Response Rate (ORR)
To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer.
Time frame: Start of treatment to 12 months
Duration of Response (DOR)
To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer.
Time frame: Start of treatment to 12 months
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
Time frame: Start of treatment to 12 months
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.
Time frame: Start of treatment to 6 months
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