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

NCT06840119 | Recruiting Phase 1 DMC

• 2 other identifiers: IMC-R117C-10042023-508090-87-00
• Study Type: interventional
• Target: 600
• Locations: 6 countries
• Sites: 13

Brief 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 PIWIL1-Positive cancers.

Conditions

Cancer; HLA-A*02:01-positive

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• 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

Study Arms (4)

Arm A: IMC-R117C Monotherapy Dose-Escalation

EXPERIMENTAL

Participants receive IMC-R117C intravenous (IV) infusion.

Drug: IMC-R117C

Arm B: IMC-R117C Combination Dose-Escalation

EXPERIMENTAL

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

Drug: IMC-R117C; Drug: Chemotherapy drug; Drug: Antiangiogenic Agent

Arm C: IMC-R117C Combination Dose-Escalation

EXPERIMENTAL

Participants receive IMC-R117C IV infusion with targeted therapies

Drug: IMC-R117C; Drug: Kinase inhibitor; Drug: Monoclonal antibody

Arm D: Control Arm

ACTIVE COMPARATOR

Participants receive standard of care chemotherapy and antiangiogenic agent

Drug: Chemotherapy drug; Drug: Antiangiogenic Agent

Interventions

IMC-R117C DRUG

IV infusion

Arm A: IMC-R117C Monotherapy Dose-Escalation; Arm B: IMC-R117C Combination Dose-Escalation; Arm C: IMC-R117C Combination Dose-Escalation

Chemotherapy drug DRUG

IV infusion

Arm B: IMC-R117C Combination Dose-Escalation; Arm D: Control Arm

Kinase inhibitor DRUG

oral

Arm C: IMC-R117C Combination Dose-Escalation

Antiangiogenic Agent DRUG

IV infusion

Arm B: IMC-R117C Combination Dose-Escalation; Arm D: Control Arm

Monoclonal antibody DRUG

IV infusion

Arm C: IMC-R117C Combination Dose-Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (13)

St Vincent's Hospital

Darlinghurst, Sydney, NSW 2010, Australia

ACTIVE NOT RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Australia

RECRUITING

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

nstituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

Hospital HM Nou Delfos

Barcelona, Spain

RECRUITING

VHIO, Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

Centro Integral Oncologico Clara Campal

Madrid, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Angiogenesis Inhibitors; Antibodies, Monoclonal

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Immunocore Medical Information

CONTACT

844-466-8661; medical.information@immunocore.com

Immunocore Medical Information EU

CONTACT

+00 800-744-51111; medinfo.eu@immunocore.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include sequential assignment for non-randomized and randomized arms.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 21, 2025
• Study Start: January 10, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

BE (3); DE (1); AU (2); ES (4); NL (1); IT (2)