Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ALX148

    Drug

    CD47 Inhibitor: A fusion protein containing a high affinity engineered D1 domain of human signal regulatory protein alpha (SIRPα) variant 1 (v1) genetically linked to a modified and inactive Fc domain of human immunoglobulin (Ig) G1.

  • Fam-Trastuzumab Deruxtecan-Nxki

    Drug

    Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor

  • Zanidatamab

    Drug

    Bispecific HER2 antibody: A humanized, bispecific, immunoglobulin G isotype 1 (IgG1)-like antibody directed against the juxtamembrane extracellular domain (ECD4) and the dimerization domain (ECD2) of human epidermal growth factor receptor 2 (HER2).

  • Tucatinib

    Drug

    Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®)Experimental treatment 2 interventions
Group B: PRE2 Zanidatamab (Ziihera®, ZW25, zani) + Tucatinib (TUKYSA®)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events related to the treatment

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

Time frame
Start of treatment to 30 days post treatment (estimated 12 -18 months)
2

Incidence of Dose Limiting Toxicities (DLTs) at each dose level

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).

Time frame
DLT observation period: Start of treatment to 21 days (Cycle 1)
3

Maximum Tolerated Dose (MTD)

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

Time frame
Start of treatment to the date of last participant at end of DLT observation period at highest dose level (estimated 6 months)
4

Recommended Phase 2 Dose (RP2D)

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

Time frame
Start of treatment to the date of last participant at highest dose level (estimated 6 months)

Secondary outcomes

1

Progression Free Survival (PFS) - descriptive

To provide descriptive assessment of Progression Free Survival (PFS) of the new agents/regimens with certain advanced solid tumors and breast cancer

Time frame
Start of treatment to 12 months
2

Clinical Benefit Rate (CBR) at 6 months

To obtain preliminary Clinical Benefit Rate (CBR) at 6 months of participants treated with the new agents/regimens.

Time frame
Start of treatment to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

QuantumLeap Healthcare Collaborative

Lead sponsor

Source ClinicalTrials.gov
Apply now