Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

A Phase 1/2 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

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 PIWIL1-Positive cancers.

Study Overview

• Status: Recruiting
• Conditions: Cancer; HLA-A*02:01-positive
• Intervention / Treatment: Drug: IMC-R117C; Drug: Chemotherapy drug; Drug: Chemotherapy drug; Drug: Antiangiogenic Agent; Drug: Kinase inhibitor; Drug: Monoclonal antibody

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Immunocore Medical Information; Phone Number: 844-466-8661; Email: medical.information@immunocore.com
• Study Contact Backup: Name: Immunocore Medical Information EU; Phone Number: +00 800-744-51111; Email: medinfo.eu@immunocore.com

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • Peter MacCallum Cancer Centre
  • Sydney
    • Darlinghurst, Sydney, Australia, NSW 2010
      • Active, not recruiting
      • St Vincent's Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
  • Ghent, Belgium
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
• Germany
  • Heidelberg, Germany
    • Recruiting
    • Universitaetsklinikum Heidelberg
• Italy
  • Roma, Italy
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Rozzano, Italy, 20089
    • Recruiting
    • nstituto Clinico Humanitas
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Antoni van Leeuwenhoek
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital HM Nou Delfos
  • Barcelona, Spain
    • Recruiting
    • VHIO, Vall d'Hebron University Hospital
  • Madrid, Spain
    • Recruiting
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: IMC-R117C Monotherapy Dose-Escalation; Participants receive IMC-R117C intravenous (IV) infusion.	Drug: IMC-R117C; IV infusion
Experimental: Arm B: IMC-R117C Combination Dose-Escalation; Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent	Drug: IMC-R117C; IV infusion; Drug: Chemotherapy drug; IV infusion; Drug: Chemotherapy drug; oral; Drug: Antiangiogenic Agent; IV infusion
Experimental: Arm C: IMC-R117C Combination Dose-Escalation; Participants receive IMC-R117C IV infusion with targeted therapies	Drug: IMC-R117C; IV infusion; Drug: Kinase inhibitor; oral; Drug: Monoclonal antibody; IV infusion
Active Comparator: Arm D: Control Arm; Participants receive standard of care chemotherapy and antiangiogenic agent	Drug: Chemotherapy drug; IV infusion; Drug: Chemotherapy drug; oral; Drug: Antiangiogenic Agent; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)	Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)	Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)	Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings	Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in vital signs	Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results	Up to ~24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation	Up to ~24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1	Up to ~24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination	Up to ~36 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination	Up to ~36 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination	Up to ~36 months
Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination	Up to ~36 months
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy	Up to ~36 months
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy	Up to ~36 months
Expansion: Overall Survival (OS) with IMC-R117C Monotherapy	Up to ~36 months
Expansion: Percentage of participants with ≥1 Adverse Events (AE)	Up to ~24 months
Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE)	Up to ~24 months
Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings	Up to ~24 months
Expansion: Percentage of participants with significant changes in vital signs	Up to ~24 months
Expansion: Percentage of participants with significant changes in laboratory findings	Up to ~24 months
Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation	Up to ~24 months
All Study: Plasma Concentration of IMC-R117C	Up to ~36 months
All Study: Incidence of anti-IMC-R117C Antibody Formation	Up to ~36 months
All Study: Incidence of tumor expression and localization of PIWIL1	Up to ~36 months

Collaborators and Investigators

• Sponsor: Immunocore Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal; Angiogenesis Inhibitors
• Other Study ID Numbers: IMC-R117C-1004; 2023-508090-87-00 (Other Identifier: EU CTR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No