PRAME PositivePhase 1NCT07156136
Study of IMC-P115C in Advanced PRAME-Positive Cancers
A Phase 1 study testing IMC-P115C in people with PRAME Positive and Cancer, run by Immunocore Ltd at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PRAME Positive, Cancer, HLA-A*02:01-positive
- What is being tested?
- IMC-P115C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 7 Nov 2024to 30 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Ongoing requirement for immunosuppressive treatment
- Significant secondary malignancy
- Hypersensitivity to study drug or excipients
- Pregnant or lactating
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
- Recruiting
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
Barcelona, 08908
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Australia3 sites, 3 recruiting
- Recruiting
Cancer Research South Australia (CRSA)
Adelaide, 5000
- Recruiting
Linear Clinical Research ltd.
Nedlands, 06009
- Recruiting
Melanoma Institute Australia
Wollstonecraft, 2065
France3 sites, 3 recruiting
- Recruiting
UNICANCER - Centre Leon-Berard (CLB)
Lyon, 69008
- Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, 31059
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Italy3 sites, 3 recruiting
- Recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Naples, 80131
About this study
Official 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
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.
- Conditions
- PRAME Positive, Cancer, HLA-A*02:01-positive
- Being tested
- IMC-P115C
- Keywords
- PRAME
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-P115CDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: IMC-P115C Monotherapy | Experimental | Participants receive IMC-P115C intravenous (IV) infusion Receives: Drug: IMC-P115C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with dose-limiting toxicities (DLT)
Measured: Up to ~16 months
Percentage of participants with adverse events (AE)
Measured: Up to ~16 months
Percentage of participants with serious adverse events (SAE)
Measured: Up to ~16 months
Percentage of participants with a dose interruption, reduction, or discontinuation
Percentage of participants with dosing changes or discontinuations.
Measured: Up to ~16 months
Secondary outcomes (8)
Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.
Measured: Up to ~19 months
Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.
Measured: Up to ~19 months
Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.
Measured: Up to ~19 months
Overall Survival (OS)
OS is the time from first dose of study therapy until death due to any cause.
Measured: Up to ~19 months
Change from baseline in lymphocyte counts
Change from baseline in lymphocyte counts
Measured: Up to ~19 months
Changes in serum cytokine concentrations
Change from baseline in serum cytokine concentrations
Measured: Up to ~19 months
IMC-P115C Plasma Concentration
IMC-P115C plasma concentration
Measured: Up to ~19 months
Percentage of participants with anti-IMC-P115C antibody formation
Measured: Up to ~19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start7 Nov 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRAME PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study will include sequential assignment for non-randomized and randomized arms.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156136
- Sponsor's protocol ID
- IMC-P115C-1005
- Other IDs
- 2023-509767-25, 2023
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07156136
- Acronym / sponsor ID
- IMC-P115C-1005
- Conditions
- PRAME Positive, Cancer, HLA-A*02:01-positive
- Keywords
- PRAME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include sequential assignment for non-randomized and randomized arms.
| Arm | Type | Receives |
|---|---|---|
| Arm A: IMC-P115C Monotherapy | Experimental | Drug: IMC-P115CParticipants receive IMC-P115C intravenous (IV) infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-P115CIV infusion | Drug | Arm A: IMC-P115C Monotherapy |
Primary outcome
Percentage of participants with dose-limiting toxicities (DLT)
Time frame: Up to ~16 months
Percentage of participants with adverse events (AE)
Time frame: Up to ~16 months
Percentage of participants with serious adverse events (SAE)
Time frame: Up to ~16 months
Percentage of participants with a dose interruption, reduction, or discontinuation
Time frame: Up to ~16 months
Percentage of participants with dosing changes or discontinuations.
8 secondary outcomes
Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Overall Survival (OS)
Time frame: Up to ~19 months
Change from baseline in lymphocyte counts
Time frame: Up to ~19 months
Changes in serum cytokine concentrations
Time frame: Up to ~19 months
IMC-P115C Plasma Concentration
Time frame: Up to ~19 months
Percentage of participants with anti-IMC-P115C antibody formation
Time frame: Up to ~19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMC-P115C in people with PRAME Positive and Cancer, run by Immunocore Ltd at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Australia, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immunocore Medical Information Global (844-466-8661, medical.information@immunocore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with dose-limiting toxicities (DLT) (time frame: Up to ~16 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.