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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
QuantumLeap Healthcare Collaborative
Study ID
NCT05868226
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Feb 15, 2023
Status verified
Apr 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PRE1 ALX148 (Evorpacept) + Fam-Trastuzumab Deruxtecan-Nxki (T-DXd, Enhertu®)
    The combination of T-DXd and ALX148 aims to explore the anti-tumoral effects of trastuzumab, of the topoisomerase inhibitor DXd and of the CD47-blocking agent ALX148. The rationale for this combination is that ALX148 is hypothesized, based on preclinical data, to facilitate antibody-dependent cellular phagocytosis (ADCP) of HER2 expressing (\>HER2 1+) breast cancer binding T-DXd while cancer cell intrinsic or bystander cytotoxicity of T-DXd will result in the release of neoantigens promoting immune mediated antitumor activity in the tumor microenvironment.
  • Experimental: PRE2 Zanidatamab (Ziihera®, ZW25, zani) + Tucatinib (TUKYSA®)
    Zanidatamab is a bispecific IgG1-like antibody directed against two distinct HER2 epitopes. It induces formation of receptor clusters and internalization resulting in downregulation. It also inhibits growth factor-dependent and -independent tumor cell proliferation and potently activates ADCC, ADCP, and CDC. FDA approved for metastatic HER2+ bile duct cancer. Tucatinib is a highly selective, small molecule tyrosine kinase inhibitor (TKI) of HER2 compared to other TKI's (i.e., EGFR). It is well tolerated, crosses the blood brain barrier and can treat CNS disease. FDA approved for HER2+ breast cancer. Given the promising clinical data for each of these drugs which have different mechanisms, the effect of zanidatamab after T-DXd (Enhertu®) in breast cancer patients, and the favorable toxicity profile of both drugs, we hypothesize that the combination of tucatinib and zanidatamab will be well tolerated and more efficacious than either drug alone for the treatment of HER2+ breast cancer.

Primary Outcome Measure

Incidence of Adverse Events related to the treatment [ Time Frame: Start of treatment to 30 days post treatment (estimated 12 -18 months) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The University of Alabama at Birmingham O'Neal Comprehensive Cancer CenterBirminghamAlabama35233
Anethea Tolliver
[email protected]
205-644-9896
Lindsey M Waldheim
[email protected]
Erica Stringer-Reasor, MD (PRINCIPAL_INVESTIGATOR)
Nusrat Jahan, MD (SUB_INVESTIGATOR)
Katia Khoury, MD (SUB_INVESTIGATOR)
Gabrielle Rocque, MD (SUB_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Jennifer Childress, RN
[email protected]
813-745-0578
Hyo Han, MD (PRINCIPAL_INVESTIGATOR)
The University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clara Duarte
[email protected]
773-834-5727
Nan Chen, MD (PRINCIPAL_INVESTIGATOR)
Rita Nanda, MD (SUB_INVESTIGATOR)
UChicago Medicine Comprehensive Cancer Center at Silver Cross HospitalNew LenoxIllinois60451
Clara Duarte
[email protected]
773-834-5727
Nan Chen, MD (PRINCIPAL_INVESTIGATOR)
UChicago Medicine Orland ParkOrland ParkIllinois60462
Clara Duarte
[email protected]
773-834-5727
Nan Chen, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455
Katie Vaughn, RN
[email protected]
612-624-6968
Erin Rogers
[email protected]
David Potter, MD, PhD (PRINCIPAL_INVESTIGATOR)
Doug Yee, MD (SUB_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Heather Walker, MPH, CCRP
[email protected]
832-564-8343
Julia Moore, RN
[email protected]
Paula R Pohlmann, MD, MSc, PhD (PRINCIPAL_INVESTIGATOR)
Funda Meric-Bernstam, MD (PRINCIPAL_INVESTIGATOR)
Debasish Tripathy, MD (SUB_INVESTIGATOR)
Jason A Mouabbi, MD (SUB_INVESTIGATOR)
Bora Lim, MD (SUB_INVESTIGATOR)
Ecaterina E Dumbrava, MD (SUB_INVESTIGATOR)

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The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center· Birmingham, ALMoffitt Cancer Center· Tampa, FLThe University of Chicago Medicine Comprehensive Cancer Center· Chicago, ILUChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital· New Lenox, ILUChicago Medicine Orland Park· Orland Park, ILUniversity of Minnesota Masonic Cancer Center· Minneapolis, MN

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