Actively Recruiting
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
Led by QuantumLeap Healthcare Collaborative · Updated on 2025-04-04
124
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for breast cancer and other solid tumors through the PRE-I-SPY/I-SPY-P1 platform trial. This open-label, multisite trial focuses on evaluating single drugs or drug combinations in metastatic cancer patients. The goal is to identify promising regimens that can advance quickly into further trials, including the I-SPY 2 SMART Design Trial. The study allows multiple arms, each with specific eligibility criteria, often including dose-finding and dose-expansion phases lasting about 12 to 18 months. The trial tests different drug combinations targeting HER2-positive breast cancer and other related tumors. One combination includes ALX148, a CD47-blocking protein, and Fam-Trastuzumab Deruxtecan-Nxki (T-DXd), an antibody-drug conjugate. Another combination studies Zanidatamab, a bispecific HER2 antibody, with Tucatinib, a selective oral drug targeting HER2. These treatments are given to explore their effects on tumor cells and the immune system. Each arm may have dose escalation and expansion parts to find the best dose and evaluate safety and response. Participants will undergo treatment and monitoring over several months, with assessments including laboratory tests, imaging, and safety evaluations. Researchers will track adverse events, dose-limiting toxicities, maximum tolerated dose, response rates, and duration of response. Follow-up will continue for up to a year to observe progression-free survival and clinical benefit. Patients must be willing to comply with study visits and procedures throughout the treatment and observation periods.
CONDITIONS
Brief 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 signed informed consent
- Age 18 years or older at time of consent
- Male or female, premenopausal or postmenopausal
- ECOG performance status grade 0 to 2
- Estimated life expectancy greater than 12 weeks at start of treatment
- Adequate organ function as shown by recent lab tests
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective contraception during treatment
- Resolution of acute toxic effects from prior therapies to grade 1 or less
- Willing and able to comply with study visits and procedures
- Additional criteria may apply based on specific treatment arm
You will not qualify if you...
- Recent anticancer therapy within specific washout periods (2 to 6 weeks depending on treatment type)
- Concurrent use of other investigational products
- History of hypersensitivity to study drugs causing treatment discontinuation
- Uncontrolled illnesses including active infection or recent pulmonary embolism
- Significant cardiovascular disease within 6 months prior to treatment
- Active or symptomatic central nervous system cancer or spinal cord compression
- Significant liver disease or alcohol abuse
- Major surgery within 4 weeks before treatment
- Pregnancy or breastfeeding
- Institutionalization due to legal or regulatory reasons
- Other conditions compromising safety or study completion
- Diagnosis of other malignancies within 2 years except certain exceptions
- Additional criteria may apply based on specific treatment arm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Start of treatment to 12 months
Participants receive experimental drug regimens involving combinations of ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab, and Tucatinib to evaluate safety, dosing, and anti-tumor effects.
Repeated visits during treatment cycles with dose-finding and dose-expansion phases
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
M
Maria Pitsiouni, PhD
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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