Actively Recruiting
PRE-I-SPY Phase I/Ib Oncology Platform Program
Led by QuantumLeap Healthcare Collaborative · Updated on 2025-04-04
124
Participants Needed
7
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRE-I-SPY Phase I/Ib Oncology Platform Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to provide written informed consent before study procedures
- Age 18 years or older at informed consent signing
- Male or female (pre- or postmenopausal)
- Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
- Estimated life expectancy greater than 12 weeks at treatment start
- Adequate organ function confirmed by lab tests within 30 days before treatment start, including specific blood counts and liver and kidney function
- Negative pregnancy test within 14 days before treatment start for women of childbearing potential; men must agree to avoid sperm donation during treatment
- Willingness to use effective contraception during treatment
- Resolution of acute toxic effects from prior therapy to grade 1 or less and neuropathy to grade 2 or less (except non-safety risk toxicities)
- Willing and able to comply with study visits, treatment, and testing
- Additional inclusion criteria may apply based on specific drug arm
You will not qualify if you...
- Recent anticancer therapy within specified washout periods (e.g., chemotherapy or investigational agents within 3 weeks)
- Concurrent use of other investigational products
- History of hypersensitivity or infusion reactions to study drugs leading to treatment discontinuation
- Uncontrolled illnesses including active infection, recent pulmonary embolism, diabetes, or psychiatric/social issues limiting compliance
- Significant cardiovascular disease within 6 months before treatment start
- Active uncontrolled central nervous system cancer or spinal cord compression, except stable or asymptomatic lesions
- Significant liver disease including viral hepatitis, alcohol abuse, or cirrhosis
- Major surgery within 4 weeks before treatment start
- Pregnancy or breastfeeding
- Institutionalization due to legal or regulatory order
- Other conditions compromising safety or study completion as judged by investigator
- Diagnosis of another malignancy within 2 years prior to study treatment except indolent or treated malignancies
- Additional exclusion criteria may apply based on specific drug arm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States, 60451
Actively Recruiting
5
UChicago Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
6
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Smita M Asare
CONTACT
M
Maria Pitsiouni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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