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PRE-ISPY Phase I/II 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 CancerMinimal Residual DiseaseColo-rectal CancerColon CancerRectal CancerctDNA MonitoringColorectal NeoplasmsColonic NeoplasmsRectal NeoplasmsNeoplasm, ResidualAdenocarcinoma of ColonAdenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuantumLeap Healthcare Collaborative

About this trial

PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial 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 for research. If FFPE blocks cannot be submitted, 20 to 40 freshly cut FFPE tissue slices (4 to 7 microns thick each) from a representative FFPE block, mounted on charged glass slides and left unstained will be acceptable. This criteria can be modified in specific drug regimens.

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. This criteria can be modified in specific drug regimens.

Disqualifiers

chemotherapy or investigational agents, 3 weeks

mitomycin C and nitrosoureas, 6 weeks

if radiotherapy is less than 5 days, 1 week wash out; if >5 days, then 2 weeks washout

for radionuclides, contact Study PI or Study Chaperone to determine washout

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALX148

    Drug

    Starting dose Dose Level 1 30mg/kg IV Q3W; Dose Level Minus 1 20 mg/kg IV Q3W (if needed); Dose Level 2 45 mg/kg IV Q3W;

  • Fam-Trastuzumab Deruxtecan-Nxki

    Drug

    5.4 mg/kg IV Q3W; allowed to dose reduce after DLT observation period

  • Zanidatamab

    Drug

    20 mg/kg IV Q2W on Day 1 and Day 15 of each 28 day cycle

  • Tucatinib

    Drug

    Dose Level 1: 300 mg PO BID daily; Dose Leve Minus 1: 250 mg PO BID daily

  • TTX-MC138

    Drug

    4.8 mg/kg Q4W IV on Day 1 for up to 12 cycles as interception therapy

Treatment groups

280 Participants
are divided into 3 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
Group C: PRE4 TTX-MC138Experimental treatment 1 intervention

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

For Phase Ib Part 1 study design: 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 end of Cycle 1
3

For select drug arms, 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

For Phase Ib Part 1 drug arms, 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

ALX Oncology Inc.

Collaborator

Pfizer

Collaborator

Jazz Pharmaceuticals

Collaborator

TransCode Therapeutics

Collaborator

Source ClinicalTrials.gov
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