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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07156136
Registration number
NCT07156136
Ethics application status
Date submitted
26/08/2025
Date registered
4/09/2025
Date last updated
4/09/2025
Titles & IDs
Public title
Study of IMC-P115C in Advanced PRAME-Positive Cancers
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Scientific title
A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC-P115C as a Single Agent and in Combination With Standard of Care Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers
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Secondary ID [1]
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2023-509767-25
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Secondary ID [2]
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IMC-P115C-1005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
PRAME Positive
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Cancer
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HLA-A*02:01-positive
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IMC-P115C
Experimental: Arm A: IMC-P115C Monotherapy - Participants receive IMC-P115C intravenous (IV) infusion
Treatment: Drugs: IMC-P115C
IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants with dose-limiting toxicities (DLT)
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Assessment method [1]
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Timepoint [1]
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Up to ~16 months
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Primary outcome [2]
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Percentage of participants with adverse events (AE)
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Assessment method [2]
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Timepoint [2]
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Up to ~16 months
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Primary outcome [3]
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Percentage of participants with serious adverse events (SAE)
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Assessment method [3]
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Timepoint [3]
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Up to ~16 months
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Primary outcome [4]
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Percentage of participants with a dose interruption, reduction, or discontinuation
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Assessment method [4]
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Percentage of participants with dosing changes or discontinuations.
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Timepoint [4]
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Up to ~16 months
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Secondary outcome [1]
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Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.
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Assessment method [1]
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Timepoint [1]
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Up to ~19 months
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Secondary outcome [2]
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Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.
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Assessment method [2]
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Timepoint [2]
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Up to ~19 months
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Secondary outcome [3]
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Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.
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Assessment method [3]
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Timepoint [3]
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Up to ~19 months
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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OS is the time from first dose of study therapy until death due to any cause.
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Timepoint [4]
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Up to ~19 months
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Secondary outcome [5]
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Change from baseline in lymphocyte counts
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Assessment method [5]
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Change from baseline in lymphocyte counts
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Timepoint [5]
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Up to ~19 months
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Secondary outcome [6]
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Changes in serum cytokine concentrations
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Assessment method [6]
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Change from baseline in serum cytokine concentrations
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Timepoint [6]
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Up to ~19 months
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Secondary outcome [7]
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IMC-P115C Plasma Concentration
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Assessment method [7]
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IMC-P115C plasma concentration
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Timepoint [7]
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Up to ~19 months
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Secondary outcome [8]
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Percentage of participants with anti-IMC-P115C antibody formation
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Assessment method [8]
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Timepoint [8]
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Up to ~19 months
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Symptomatic or untreated central nervous system metastasis
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2029
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cancer Research South Australia (CRSA) - Adelaide
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Recruitment hospital [2]
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Linear Clinical Research ltd. - Nedlands
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Recruitment hospital [3]
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Melanoma Institute Australia - Wollstonecraft
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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06009 - Nedlands
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Recruitment postcode(s) [3]
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2065 - Wollstonecraft
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Lyon
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Country [2]
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France
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State/province [2]
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Toulouse
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Country [3]
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France
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State/province [3]
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Villejuif
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Country [4]
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Italy
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State/province [4]
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Milan
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Country [5]
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Italy
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State/province [5]
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Napoli
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Country [6]
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Spain
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State/province [6]
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Barcelona
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Country [7]
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Spain
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State/province [7]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Immunocore Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
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Trial website
https://clinicaltrials.gov/study/NCT07156136
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Immunocore Medical Information Global
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Address
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Country
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Phone
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844-466-8661
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07156136
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