A Phase I/II First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers

Study Identifier:
IMC-R117C-1004
CT.gov Identifier:
NCT06840119
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508090-87-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced cancers.

To evaluate the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination in HLA-A*02:01-positive participants with selected advanced PIWIL1-positive cancers

To evaluate the safety and clinical activity of IMC-R117C (targeting PIWIL1) in HLA-A*02:01-positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Arm A
    • Read More
  • Drug: Experimental: Arm B
  • Drug: Experimental: Arm C
  • Drug: Active Comparator: Arm D
  • Drug: Role: Test Name: FLUOROURACIL
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
    • * HLA-A\*02:01-positive
    • * Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
    • * Archived or fresh tumor tissue sample that must be confirmed as adequate
    • * Evaluable/Measurable disease per RECIST 1.1
    • * Previously received applicable standard treatments
    • * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
    • Age ≥ 18 years
    • ECOG PS 0 or 1
    • HLA-A*02:01 positive
    • Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
    • Meeting PIWIL1 testing requirements
    • Baseline disease evaluation / measurable based on investigator assessment
    • Meeting the histology, biomarker, and prior cancer treatment requirements for the applicable arm and study part
    • Contraception
    • Informed Consent
    Exclusion criteria
    • * Symptomatic or untreated central nervous system metastasis
    • * Recent bowel obstruction
    • * Ongoing ascites or effusion requiring recent drainages
    • * Significant ongoing toxicity from prior anticancer treatment
    • * Out-of-range laboratory values
    • * Clinically significant lung, heart, or autoimmune disease
    • * Ongoing requirement for immunosuppressive treatment
    • * Significant secondary malignancy
    • * Hypersensitivity to study drug or excipients
    • * Pregnant or lactating
    • Presence of untreated / symptomatic CNS metastases, leptomeningeal disease, or cord compression
    • Recent bowel obstruction
    • High risk for vital organ perforation, fistula formation, or hemorrhage
    • Ongoing ascites or effusion
    • Ongoing toxicity from prior cancer therapy
    • Hypersensitivity to study treatment or excipient
    • Inadequate washout from prior cancer treatment
    • Prior treatment with an ImmTAC molecule
    • Other contraindication for applicable combination partner
    • Out of range laboratory values
    • Significant pulmonary disease or impaired lung function
    • Significant cardiac disease or impaired cardiac function
    • Specific exclusions for combination partner
    • Active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease
    • Systemic treatment with steroids or any other immunosuppressive drug use
    • Prior solid organ or bone marrow transplant
    • Uncontrolled or untreated chronic viral infection
    • History of malignant diseases other than those being treated in this study
    • Recent antibiotic use
    • Recent major surgical procedure

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer