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

NCT06840119
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
600
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Lead sponsor
Immunocore Ltd
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Start date
2024-01-10
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Number of sites
13
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-11-30
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First posted
2025-02-21
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Registry last updated
2026-01-28
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Primary completion date
2026-11-30
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Start date
2024-01-10
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Participants
600
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Participant count basis
Estimated
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Planned participants
600
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Protocol amendments
1
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Number of sites
13
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Immunocore Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06840119
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ClinicalTrials.gov ID
NCT06840119
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-508090-87-00
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Targets (4)