PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.
The PRE-ISPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. Each drug regimen arm may have a Phase I dose-finding group (Part 1), a dose-expansion group (Part 2), and/or a Phase II component. Participant eligibility may vary according to the investigational arm or the part within the study arm, including with respect to diagnosis. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis (e.g. metastatic TNBC or MRD CRC). 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
280
Starting dose Dose Level 1 30mg/kg IV Q3W; Dose Level Minus 1 20 mg/kg IV Q3W (if needed); Dose Level 2 45 mg/kg IV Q3W;
5.4 mg/kg IV Q3W; allowed to dose reduce after DLT observation period
20 mg/kg IV Q2W on Day 1 and Day 15 of each 28 day cycle
Dose Level 1: 300 mg PO BID daily; Dose Leve Minus 1: 250 mg PO BID daily
4.8 mg/kg Q4W IV on Day 1 for up to 12 cycles as interception therapy
The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States
RECRUITINGMayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
NOT_YET_RECRUITINGUniversity of Colorado Cancer Center
Aurora, Colorado, United States
ACTIVE_NOT_RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
ACTIVE_NOT_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
RECRUITINGMayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States
NOT_YET_RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
ACTIVE_NOT_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)
For Phase Ib Part 1 study design: 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 end of Cycle 1
For select drug arms, 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)
For Phase Ib Part 1 drug arms, 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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