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
140 participants
INTERVENTIONAL
2024-11-07
2029-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A: IMC-P115C Monotherapy
Participants receive IMC-P115C intravenous (IV) infusion
IMC-P115C
IV infusion
Interventions
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IMC-P115C
IV infusion
Eligibility Criteria
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Inclusion Criteria
* HLA-A\*02:01-positive
* Meeting PRAME-positive tumor testing requirements
* Metastatic or unresectable solid tumors
* Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
* 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
* Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
* 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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Cancer Research South Australia (CRSA)
Adelaide, , Australia
Linear Clinical Research ltd.
Nedlands, , Australia
Melanoma Institute Australia
Wollstonecraft, , Australia
UNICANCER - Centre Leon-Berard (CLB)
Lyon, , France
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Napoli, , Italy
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2023-509767-25
Identifier Type: OTHER
Identifier Source: secondary_id
IMC-P115C-1005
Identifier Type: -
Identifier Source: org_study_id
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