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CancerPhase 1/2NCT06840119

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

A Phase 1/2 study testing IMC-R117C, Chemotherapy drug and Kinase inhibitor in people with Cancer and HLA-A*02:01-positive, run by Immunocore Ltd at 13 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, HLA-A*02:01-positive
What is being tested?
IMC-R117C, Chemotherapy drug and Kinase inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
13 sitesin 6 countries
Study dates
10 Jan 2024to 30 Nov 2027
Phase
Phase 1/2
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
  • 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

Who cannot join

  • 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
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 6 countries. Contact the study team or a site near you to ask about taking part.

Immunocore Medical Information contact

844-466-8661

medical.information@immunocore.com

Immunocore Medical Information EU contact

+00 800-744-51111

medinfo.eu@immunocore.com

13 sites in 6 countries

Spain4 sites, 4 recruiting

  • Hospital HM Nou Delfos

    Barcelona

    Recruiting

  • VHIO, Vall d'Hebron University Hospital

    Barcelona

    Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

    Recruiting

Other trials in Spain

Belgium3 sites, 3 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Australia2 sites, 1 recruiting

  • St Vincent's Hospital

    Darlinghurst, Sydney, NSW 2010

    Active, not recruiting

  • Peter MacCallum Cancer Centre

    Melbourne

    Recruiting

Other trials in Australia

Italy2 sites, 2 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Recruiting

  • nstituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

Germany1 site, 1 recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg

    Recruiting

Other trials in Germany

Netherlands1 site, 1 recruiting

  • Antoni van Leeuwenhoek

    Amsterdam

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers

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.

Being tested
IMC-R117C, Chemotherapy drug, Kinase inhibitor, Antiangiogenic Agent, Monoclonal antibody
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMC-R117CDrug

    IV infusion

  • Chemotherapy drugDrug

    IV infusion

  • Chemotherapy drugDrug

    oral

  • Kinase inhibitorDrug

    oral

  • Antiangiogenic AgentDrug

    IV infusion

  • Monoclonal antibodyDrug

    IV infusion

Study groups in NCT06840119
Study groupRoleWhat they receive
Arm A: IMC-R117C Monotherapy Dose-EscalationExperimentalParticipants receive IMC-R117C intravenous (IV) infusion.
Receives: Drug: IMC-R117C
Arm B: IMC-R117C Combination Dose-EscalationExperimentalParticipants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent
Receives: Drug: IMC-R117C; Drug: Chemotherapy drug; Drug: Antiangiogenic Agent
Arm C: IMC-R117C Combination Dose-EscalationExperimentalParticipants receive IMC-R117C IV infusion with targeted therapies
Receives: Drug: IMC-R117C; Drug: Kinase inhibitor; Drug: Monoclonal antibody
Arm D: Control ArmActive comparatorParticipants receive standard of care chemotherapy and antiangiogenic agent
Receives: Drug: Chemotherapy drug; Drug: Antiangiogenic Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)

    Measured: Up to ~24 months

  2. Dose Escalation: Percentage of participants with ≥1 adverse event (AE)

    Measured: Up to ~24 months

  3. Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)

    Measured: Up to ~24 months

  4. Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings

    Measured: Up to ~24 months

  5. Dose Escalation: Percentage of participants with significant changes in vital signs

    Measured: Up to ~24 months

  6. Dose Escalation: Percentage of participants with significant changes in laboratory results

    Measured: Up to ~24 months

  7. Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation

    Measured: Up to ~24 months

  8. Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1

    Measured: Up to ~24 months

Secondary outcomes (16)

  1. Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

    Measured: Up to ~36 months

  2. Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

    Measured: Up to ~36 months

  3. Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination

    Measured: Up to ~36 months

  4. Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination

    Measured: Up to ~36 months

  5. Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy

    Measured: Up to ~36 months

  6. Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy

    Measured: Up to ~36 months

  7. Expansion: Overall Survival (OS) with IMC-R117C Monotherapy

    Measured: Up to ~36 months

  8. Expansion: Percentage of participants with ≥1 Adverse Events (AE)

    Measured: Up to ~24 months

  9. Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE)

    Measured: Up to ~24 months

  10. Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings

    Measured: Up to ~24 months

  11. Expansion: Percentage of participants with significant changes in vital signs

    Measured: Up to ~24 months

  12. Expansion: Percentage of participants with significant changes in laboratory findings

    Measured: Up to ~24 months

  13. Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation

    Measured: Up to ~24 months

  14. All Study: Plasma Concentration of IMC-R117C

    Measured: Up to ~36 months

  15. All Study: Incidence of anti-IMC-R117C Antibody Formation

    Measured: Up to ~36 months

  16. All Study: Incidence of tumor expression and localization of PIWIL1

    Measured: Up to ~36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start10 Jan 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study will include sequential assignment for non-randomized and randomized arms.
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840119
Sponsor's protocol ID
IMC-R117C-1004
Other IDs
2023-508090-87-00, 2023
Status last verified
Jan 2026
First submitted
5 Feb 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMC-R117C, Chemotherapy drug and Kinase inhibitor in people with Cancer and HLA-A*02:01-positive, run by Immunocore Ltd at 13 sites in 6 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 7 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 28 Jan 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, Belgium, Australia, Italy, Germany and 1 more country. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (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?

Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) (time frame: Up to ~24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840119.

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 28 Jan 2026.

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