PRE-ISPY Phase I/II Oncology Platform Program
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests cancer drugs alone or together to find promising treatments for larger studies. It is for adults with solid tumors that have grown nearby, have spread, cannot be cured, or have a high risk of coming back after treatment meant to cure them.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older. Men and women may join.
- Understand and sign a consent form before study tests, and provide stored tumor tissue for research.
- Be able to care for yourself and be out of bed or a chair for at least half the day. Be expected to live more than 12 weeks.
- Have blood tests showing that your blood counts, liver, and kidneys meet the study’s requirements.
- Have recovered from surgery and most side effects of earlier treatment. Some ongoing side effects may be allowed.
- If you can become pregnant, have a negative pregnancy test within 14 days before treatment. Follow the study’s birth control rules; men must not donate sperm during treatment.
- Be willing and able to follow the treatment plan, attend visits, and complete tests.
- Meet any extra rules for your study drug group. Some general rules may differ by group.
Who can't join
- Have had cancer treatment too recently, or are taking another study drug. Waiting times depend on the treatment; hormone treatment needs no waiting period.
- Have had a reaction to a study drug or its ingredients that required stopping that treatment for good.
- Have an uncontrolled illness, such as an active infection or diabetes; a stroke within 6 months; or another health or life issue that could make the study unsafe or hard to complete.
- Have certain serious heart or blood vessel problems within 6 months, an abnormal heart rhythm on testing, or significant liver disease, including hepatitis or liver scarring.
- Have uncontrolled cancer in the brain or spinal cord, symptoms from it, or pressure on the spinal cord. Some treated, stable areas or new areas without symptoms may be allowed.
- Have had major surgery within 4 weeks before study treatment, are pregnant, or are breastfeeding.
- Are in prison or placed in an institution by a legal or regulatory order.
- Have had another cancer diagnosed within 2 years, unless it meets the study’s exceptions. Each study drug group may have extra reasons someone cannot join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 for research. If FFPE blocks cannot be submitted, 20 to 40 freshly cut FFPE tissue slices (4 to 7 microns thick each) from a representative FFPE block, mounted on charged glass slides and left unstained will be acceptable. This criteria can be modified in specific drug regimens. * 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. This criteria can be modified in specific drug regimens. * 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: Other anticancer therapy within the following period: * chemotherapy or investigational agents, 3 weeks * mitomycin C and nitrosoureas, 6 weeks * if radiotherapy is less than 5 days, 1 week wash out; if \>5 days, then 2 weeks washout * for radionuclides, contact Study PI or Study Chaperone to determine washout * 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, adrenal insufficiency, pulmonary embolism, stroke 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. Exception: Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, including new parenchymal lesions or leptomeningeal disease, if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy, after consultation with study regimen chaperones, may be permitted. This criteria can be modified in specific drug regimens. * 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. * GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of participants, or affect the endpoints of the trial. * Additional arm specific exclusion criteria as needed by drug arm regimen
Study sites (10)
AL
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center · Birmingham, AL 35233Anethea Tolliver · Study contact · 205-644-9896 · anetheatolliver@uabmc.eduLindsey M Waldheim · Study contact · lwaldheim@uabmc.eduErica Stringer-Reasor, MD · Principal investigatorNusrat Jahan, MD · Sub-investigatorMore trials in Birmingham
AZ
- Mayo Clinic Comprehensive Cancer Center · Phoenix, AZ 85054Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduLida Mina, MD · Sub-investigatorMojun Zhu, MD · Sub-investigatorMore trials in Phoenix
CO
- University of Colorado Cancer Center · Aurora, CO 80045More trials in Aurora
FL
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa
IL
- The University of Chicago Medicine Comprehensive Cancer Center · Chicago, IL 60637Clara Duarte · Study contact · 773-834-5727 · vqq5698@bsd.uchicago.eduNan Chen, MD · Principal investigatorRita Nanda, MD · Sub-investigatorArdaman Shergill, MD, MSPH · Sub-investigatorMore trials in Chicago
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital · New Lenox, IL 60451Clara Duarte · Study contact · 773-834-5727 · vqq5698@bsd.uchicago.eduNan Chen, MD · Principal investigatorMore trials in New Lenox
- UChicago Medicine Orland Park · Orland Park, IL 60462Clara Duarte · Study contact · 773-834-5727 · vqq5698@bsd.uchicago.eduNan Chen, MD · Principal investigatorMore trials in Orland Park
MN
- University of Minnesota Masonic Cancer Center · Minneapolis, MN 55455Katie Vaughn, RN · Study contact · 612-624-6968 · schro811@umn.eduErin Rogers · Study contact · roge0507@umn.eduDavid Potter, MD, PhD · Principal investigatorAnne Blaes, MD, MS · Sub-investigatorMore trials in Minneapolis
- Mayo Clinic Comprehensive Cancer Center · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduRoberto A Leon-Ferre, MD · Principal investigatorZhaohui Jin, MD · Sub-investigatorMore trials in Rochester
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston