Health Trials

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

ConditionsHER2-positive Breast CancerMetastatic CancerMetastatic Breast CancerMetastaticHER2-positive Metastatic Breast CancerHER2 Mutation-Related TumorsHER-2 Protein OverexpressionHER2-negative Breast CancerTriple Negative Breast CancerHR PositiveHormone Receptor-positive Breast CancerEstrogen Receptor Positive TumorProgesterone Receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaSolid TumorSolid Tumor, AdultSolid CarcinomaHER2 Low Breast CancerHER2 Low Breast CarcinomaER Positive Breast CancerPR-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuantumLeap Healthcare Collaborative

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

chemotherapy or investigational agents, 3 weeks

mitomycin C and nitrosoureas, 6 weeks

radiotherapy, 3 weeks

targeted therapy, 2 weeks

Trial design

Treatments tested in this trial

  • ALX148
  • Fam-Trastuzumab Deruxtecan-Nxki
  • Zanidatamab
  • Tucatinib

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

QuantumLeap Healthcare Collaborative

Lead sponsor

Source ClinicalTrials.gov