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

January 26, 2026 updated by: Immunocore Ltd

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunocore Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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