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

NCT ID: NCT06840119

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer HLA-A*02:01-positive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The study will include sequential assignment for non-randomized and randomized arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: IMC-R117C Monotherapy Dose-Escalation

Participants receive IMC-R117C intravenous (IV) infusion.

Group Type EXPERIMENTAL

IMC-R117C

Intervention Type DRUG

IV infusion

Arm B: IMC-R117C Combination Dose-Escalation

Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent

Group Type EXPERIMENTAL

IMC-R117C

Intervention Type DRUG

IV infusion

Chemotherapy drug

Intervention Type DRUG

IV infusion

Chemotherapy drug

Intervention Type DRUG

oral

Antiangiogenic Agent

Intervention Type DRUG

IV infusion

Arm C: IMC-R117C Combination Dose-Escalation

Participants receive IMC-R117C IV infusion with targeted therapies

Group Type EXPERIMENTAL

IMC-R117C

Intervention Type DRUG

IV infusion

Kinase inhibitor

Intervention Type DRUG

oral

Monoclonal antibody

Intervention Type DRUG

IV infusion

Arm D: Control Arm

Participants receive standard of care chemotherapy and antiangiogenic agent

Group Type ACTIVE_COMPARATOR

Chemotherapy drug

Intervention Type DRUG

IV infusion

Antiangiogenic Agent

Intervention Type DRUG

IV infusion

Interventions

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IMC-R117C

IV infusion

Intervention Type DRUG

Chemotherapy drug

IV infusion

Intervention Type DRUG

Chemotherapy drug

oral

Intervention Type DRUG

Kinase inhibitor

oral

Intervention Type DRUG

Antiangiogenic Agent

IV infusion

Intervention Type DRUG

Monoclonal antibody

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunocore Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Vincent's Hospital

Darlinghurst, Sydney, Australia

Site Status ACTIVE_NOT_RECRUITING

Peter MacCallum Cancer Centre

Melbourne, , Australia

Site Status RECRUITING

Institut Jules Bordet

Anderlecht, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

nstituto Clinico Humanitas

Rozzano, , Italy

Site Status RECRUITING

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status RECRUITING

Hospital HM Nou Delfos

Barcelona, , Spain

Site Status RECRUITING

VHIO, Vall d'Hebron University Hospital

Barcelona, , Spain

Site Status RECRUITING

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Countries

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Australia Belgium Germany Italy Netherlands Spain

Central Contacts

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Immunocore Medical Information

Role: CONTACT

844-466-8661

Immunocore Medical Information EU

Role: CONTACT

+00 800-744-51111

Other Identifiers

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2023-508090-87-00

Identifier Type: OTHER

Identifier Source: secondary_id

IMC-R117C-1004

Identifier Type: -

Identifier Source: org_study_id

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