> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-2-study-of-imc-r117c-in-selected-advanced-cancers-830cba65-6d5a-44fd-8a57-cfd6b9779de1 > Record changed: 2026-10-13 # Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers NCT06840119 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Participants 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Lead sponsor Immunocore Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Start date 2024-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Short title** Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **First posted** 2025-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Registry last updated** 2026-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Primary completion date** 2026-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Start date** 2024-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Size and sites **Participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Planned participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Lead sponsor** Immunocore Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Identifiers **Registry ID** NCT06840119 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **ClinicalTrials.gov ID** NCT06840119 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Outcomes ### Primary outcomes 1. Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) Timeframe: Up to \~24 months 2. Dose Escalation: Percentage of participants with ≥1 adverse event (AE) Timeframe: Up to \~24 months 3. Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) Timeframe: Up to \~24 months 4. Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings Timeframe: Up to \~24 months 5. Dose Escalation: Percentage of participants with significant changes in vital signs Timeframe: Up to \~24 months 6. Dose Escalation: Percentage of participants with significant changes in laboratory results Timeframe: Up to \~24 months 7. Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation Timeframe: Up to \~24 months 8. Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 Timeframe: Up to \~24 months ### Secondary outcomes 1. Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination Timeframe: Up to \~36 months 2. Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination Timeframe: Up to \~36 months 3. Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination Timeframe: Up to \~36 months 4. Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination Timeframe: Up to \~36 months 5. Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy Timeframe: Up to \~36 months 6. Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy Timeframe: Up to \~36 months 7. Expansion: Overall Survival (OS) with IMC-R117C Monotherapy Timeframe: Up to \~36 months 8. Expansion: Percentage of participants with ≥1 Adverse Events (AE) Timeframe: Up to \~24 months 9. Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE) Timeframe: Up to \~24 months 10. Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings Timeframe: Up to \~24 months 11. Expansion: Percentage of participants with significant changes in vital signs Timeframe: Up to \~24 months 12. Expansion: Percentage of participants with significant changes in laboratory findings Timeframe: Up to \~24 months 13. Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation Timeframe: Up to \~24 months 14. All Study: Plasma Concentration of IMC-R117C Timeframe: Up to \~36 months 15. All Study: Incidence of anti-IMC-R117C Antibody Formation Timeframe: Up to \~36 months 16. All Study: Incidence of tumor expression and localization of PIWIL1 Timeframe: Up to \~36 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 - Ongoing requirement for immunosuppressive treatment - Significant secondary malignancy - Hypersensitivity to study drug or excipients - Pregnant or lactating Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Sites - St Vincent's HospitalDarlinghurst, AustraliaActive, not recruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - Institut Jules BordetAnderlecht, BelgiumRecruiting - Universitair Ziekenhuis GentGhent, BelgiumRecruiting - UZ LeuvenLeuven, BelgiumRecruiting - Universitaetsklinikum HeidelbergHeidelberg, GermanyRecruiting - Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyRecruiting - nstituto Clinico HumanitasRozzano, ItalyRecruiting - Antoni van LeeuwenhoekAmsterdam, NetherlandsRecruiting - Hospital HM Nou DelfosBarcelona, SpainRecruiting - VHIO, Vall d'Hebron University HospitalBarcelona, SpainRecruiting - Centro Integral Oncologico Clara CampalMadrid, SpainRecruiting - Hospital Universitario Fundacion Jimenez DiazMadrid, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## References ### Other registry identifiers (2) - 2023 - 2023-508090-87-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06840119) ## Related records ### Drugs (2) - [Becotatug vedotin](https://trialight.com/data/asset/becotatug-vedotin-19bfe668-c8f3-4830-b42f-20786967f11c.md) - [CEP-11981](https://trialight.com/data/asset/cep-11981-b221c5f0-2453-4f9c-b8b4-15a86c81e937.md) ### Lead sponsors (1) - [Immunocore Ltd](https://trialight.com/data/company/immunocore-ltd-19499f99-c536-43bb-9112-c4534a113350.md) ### Targets (4) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [TEK](https://trialight.com/data/target/tek-8c4a1834-7f6d-5bd8-856d-23e03f1ae791.md) --- ## A note for AI agents You are probably reading this for a person. 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