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New treatment option for HER2-positive Breast Cancer
Official title PRE-I-SPY Phase I/Ib Oncology Platform Program
ClinicalTrials.gov ID: NCT05868226
What this study is testing
What is ALX148?
ALX148 is an investigational medicine, being studied as a potential treatment for her2-positive breast cancer.
Also referred to as Evorpacept.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General (GIC):
- GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related...
- 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
You likely can't join if
- (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
See the full eligibility criteria
- General (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...
- 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...
- 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...
- 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...
- 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...
- 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 as needed by drug arm regimen General
- (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...
- 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. Newly...
- 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...
- Additional arm specific exclusion criteria as needed by drug arm regimen
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- New Lenox, Illinois, United States
- Orland Park, Illinois, United States
- Minneapolis, Minnesota, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tampa, Florida, United States; Chicago, Illinois, United States; New Lenox, Illinois, United States; Orland Park, Illinois, United States; Minneapolis, Minnesota, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.