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Recruiting Phase 1/2 NCT06840119

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

Phase 1/2 – combined early trial
Conditions: Cancer HLA-A*02:01-positive

Sponsor: Immunocore Ltd

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 6
Australia (1)
St Vincent's Hospital
Darlinghurst , Sydney
ACTIVE_NOT_RECRUITING
Belgium (1)
Institut Jules Bordet
Anderlecht
Germany (1)
Universitaetsklinikum Heidelberg
Heidelberg
Italy (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Netherlands (1)
Antoni van Leeuwenhoek
Amsterdam
Spain (1)
Hospital HM Nou Delfos
Barcelona
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.01.2024
Completion date
30.11.2027
Registry ID
NCT06840119
Source
anzctr
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