CLINICAL TRIAL / NCT05868226
PRE-I-SPY Phase I/Ib Oncology Platform Program
- Interventional
- Recruiting
- NCT05868226
Contact Information
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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 (freshly cut 14 unstained
tumor slides would be acceptable).
- 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
- 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: No other anticancer therapy within the following periods:
- chemotherapy or investigational agents, 3 weeks
- mitomycin C and nitrosoureas, 6 weeks
- radiotherapy, 3 weeks
- 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,
pulmonary embolism 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.
- 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.
- Additional arm specific exclusion criteria as needed by drug arm regimen
- Breast Cancer
- Metastatic Cancer
- Solid Tumors