Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
NCT ID: NCT06840119
Last Updated: 2026-01-28
Study Results
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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RECRUITING
PHASE1/PHASE2
600 participants
INTERVENTIONAL
2024-01-10
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A: IMC-R117C Monotherapy Dose-Escalation
Participants receive IMC-R117C intravenous (IV) infusion.
IMC-R117C
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
IMC-R117C
IV infusion
Chemotherapy drug
IV infusion
Chemotherapy drug
oral
Antiangiogenic Agent
IV infusion
Arm C: IMC-R117C Combination Dose-Escalation
Participants receive IMC-R117C IV infusion with targeted therapies
IMC-R117C
IV infusion
Kinase inhibitor
oral
Monoclonal antibody
IV infusion
Arm D: Control Arm
Participants receive standard of care chemotherapy and antiangiogenic agent
Chemotherapy drug
IV infusion
Antiangiogenic Agent
IV infusion
Interventions
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IMC-R117C
IV infusion
Chemotherapy drug
IV infusion
Chemotherapy drug
oral
Kinase inhibitor
oral
Antiangiogenic Agent
IV infusion
Monoclonal antibody
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Immunocore Ltd
INDUSTRY
Responsible Party
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Locations
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St Vincent's Hospital
Darlinghurst, Sydney, Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Institut Jules Bordet
Anderlecht, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
nstituto Clinico Humanitas
Rozzano, , Italy
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Hospital HM Nou Delfos
Barcelona, , Spain
VHIO, Vall d'Hebron University Hospital
Barcelona, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Central Contacts
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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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