Clinical Trial 23249

• Overview

  Study Title:

  PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial

  Summary:

  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.

  Objective:

  Primary Objectives: * To determine the safety and tolerability of new agents/regimens in participants with certain advanced solid tumors and breast cancer * To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer Secondary Objectives: * To provide descriptive assessment of Progression-Free Survival (PFS) of the new agents/regimens with certain advanced solid tumors and breast cancer * To obtain preliminary Clinical Benefit Rate (CBR) at 6 months of participants treated with the new agents/regimens * Biospecimen acquisition

• Treatments

  Therapies:

  Antibody-Drug Conjugate; Immunotherapy; TLR9 agonist; Tyrosine Kinase Inhibitor

  Medications:

  ALX148 (); Cemiplimab (); REGN2810 (Cemiplimab); T-Dxd (); Tucatinib (); Vidutolimod (); Zanidatamab ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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).
  • Age ≥ 18 years at the time of signing the informed consent.
  • Gender: Male or female (premenopausal and postmenopausal).
  • ECOG performance status Grade 0-2.
  • Estimated life expectancy > 12 weeks at the start of investigational medicinal product (IMP) treatment.
  • Adequate organ function as defined by the protocol.
  • Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential.
  • Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment.
  • Prior therapy effects: Resolution of all acute toxic effects of prior therapy.
  • Participant compliance: Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Concurrent therapy with other Investigational Products.
  • 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.
  • 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).
  • 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.
  • Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.
  • Recent major surgery within 4 weeks prior to start IMP treatment.
  • Pregnancy or breastfeeding.
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
  • 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.
  • Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study.
  • Other exclusion criteria may apply.

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