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Clinical Trials in Italy / NCT06840119
Recruiting Phase 1/2

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

NCT06840119 · tracked via the Priya Life Science Italy tracker
Sponsor
Immunocore Ltd
Phase
Phase 1/2
Started
2024-01-10
Last updated
2026-01-28

Condition(s) studied

CancerHLA-A*02:01-positive

Investigational drug(s) / intervention(s)

IMC-R117CChemotherapy drugChemotherapy drugKinase inhibitorAntiangiogenic AgentMonoclonal antibody

IMC-R117C: IV infusion

Chemotherapy drug: IV infusion

Chemotherapy drug: oral

Kinase inhibitor: oral

Antiangiogenic Agent: IV infusion

Monoclonal antibody: IV infusion

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 PIWIL1-Positive cancers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (13)

FacilityCityRegionStatus
St Vincent's Hospital Darlinghurst Sydney Active Not Recruiting
Peter MacCallum Cancer Centre Melbourne Australia Recruiting
Institut Jules Bordet Anderlecht Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Universitaetsklinikum Heidelberg Heidelberg Germany Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Recruiting
nstituto Clinico Humanitas Rozzano 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

More Immunocore Ltd trials in Italy

Study of IMC-P115C in Advanced PRAME-Positive Cancers Recruiting
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) Recruiting
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) Recruiting
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors Active, not recruiting

Other trials for the same condition

Study of IMC-P115C in Advanced PRAME-Positive Cancers Recruiting
Met Non Small Cell Cancer Registry (MOMENT) Recruiting
Longitudinal Registry Including Patients Treated With Heavy Particles Recruiting
E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe Recruiting
Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06840119 on ClinicalTrials.gov ↗ ← All trials in Italy