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NCT Number: NCT06840119

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

Recruiting

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Key information

Conditions

Cancer HLA-A*02:01-positive Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St Vincent's Hospital, Darlinghurst, Sydney, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMC-R117C

Drug

IV infusion

Chemotherapy drug

Drug

IV infusion

Kinase inhibitor

Drug

oral

Antiangiogenic Agent

Drug

IV infusion

Monoclonal antibody

Drug

IV infusion

Primary outcomes

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: 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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

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

    Time frame: Up to ~24 months

  14. All Study: Plasma Concentration of IMC-R117C

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

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

    Time frame: Up to ~36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Immunocore Medical Information

CONTACT

[email protected]

844-466-8661

Immunocore Medical Information EU

CONTACT

[email protected]

+00 800-744-51111

Sponsors and collaborators

Lead sponsor

Immunocore Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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