Back to search results

PRE-I-SPY Platform Study for Metastatic HER2-positive Breast Cancer

This study, called PRE-I-SPY, is looking for people aged 18 and older with HER2-positive metastatic breast cancer (cancer that has spread). It's a platform study, meaning it tests several different treatments at once. The treatments being studied include ALX148 (a CD47 Inhibitor), Fam-Trastuzumab Deruxtecan-Nxki (an antibody-drug conjugate), Zanidatamab (a bispecific HER2 antibody), and Tucatinib (an oral medicine that targets HER2). The main goals are to find out how safe these treatments are, what side effects they cause, and to determine the highest safe dose. The study is currently unclear on its recruitment status and plans to enroll 124 participants. You will need to provide a signed consent form and tumor tissue samples to participate.

Study design
This is an open-label (you and your doctors will know what treatment you receive), multisite platform study that evaluates single agents or combinations. It includes dose-finding and dose-expansion groups, with a planned enrollment of 124 participants.
What's involved
You will need to provide signed written informed consent and tumor tissue samples. The study will measure adverse events from the start of treatment to 30 days after treatment, and dose-limiting toxicities for 21 days in the first cycle.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured up to 30 days after treatment. Dose-limiting toxicities are observed for 21 days during the first cycle of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05868226

PRE-I-SPY Phase I/Ib Oncology Platform Program

Recruiting
PHASE1Ages 18+InterventionalTreatment
QuantumLeap Healthcare Collaborative
~124 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:ALX148Fam-Trastuzumab Deruxtecan-NxkiZanidatamabTucatinib

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events related to the treatment
Measured over Start of treatment to 30 days post treatment (estimated 12 -18 months)
+5 more outcomes measured

Conditions

HER2-positive Breast Cancer
Metastatic Cancer
Metastatic Breast Cancer
Metastatic
HER2-positive Metastatic Breast Cancer
HER2 Mutation-Related Tumors
HER-2 Protein Overexpression
HER2-negative Breast Cancer
Triple Negative Breast Cancer
HR Positive
Hormone Receptor-positive Breast Cancer
Estrogen Receptor Positive Tumor
Progesterone Receptor-positive Breast Cancer
Hormone Receptor Negative Breast Carcinoma
Solid Tumor
Solid Tumor, Adult
Solid Carcinoma
HER2 Low Breast Cancer
HER2 Low Breast Carcinoma
ER Positive Breast Cancer
PR-positive Breast Cancer

Explore related trials

Breast CarcinomaSolid Neoplasm

Where it's being run

7 sites across 5 states
Illinois3
Alabama1
Florida1
Minnesota1
Texas1

Study leadership

  • Paula R Pohlmann, MD, MSc, PhD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Smita M Asare
[email protected]
(855) 866-0505 · ext. 104
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.

Exclusion

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. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be 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.
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 subjects, or affect the endpoints of the trial.

What this trial measures

  • Incidence of Adverse Events related to the treatmentStart of treatment to 30 days post treatment (estimated 12 -18 months)

    Evaluate the number of adverse events related to the treatment according to the current version of CTCAE during the trial.

  • Incidence of Dose Limiting Toxicities (DLTs) at each dose levelDLT observation period: Start of treatment to 21 days (Cycle 1)

    To determine the safety and tolerability of new agents/regimens in participants with certain advanced solid tumors and breast cancer. DLT rate (number of participants who experience a protocol defined DLT/total number of DLT cohort participants at that dose).

  • Maximum Tolerated Dose (MTD)Start of treatment to the date of last participant at end of DLT observation period at highest dose level (estimated 6 months)

    The maximum dose level (mg/kg) which is not eliminated.

  • Recommended Phase 2 Dose (RP2D)Start of treatment to the date of last participant at highest dose level (estimated 6 months)

    Using all available data, computation of RP2D (mg/kg), which may not be the MTD.

  • Overall Response Rate (ORR)Start of treatment to 12 months

    To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer.

  • Duration of Response (DOR)Start of treatment to 12 months

    To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer.