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Recruiting NCT06840119

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

Phase I / Phase II Interventional Cancer HLA-A*02:01-positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMC-R117C, Chemotherapy drug, Chemotherapy drug, Kinase inhibitor.
Who it may be relevant to
Registry conditions: Cancer, HLA-A*02:01-positive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Belgium, Germany, Italy, Netherlands +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug IMC-R117C
    IV infusion
  • Drug Chemotherapy drug
    IV infusion
  • Drug Chemotherapy drug
    oral
  • Drug Kinase inhibitor
    oral
  • Drug Antiangiogenic Agent
    IV infusion
  • Drug Monoclonal antibody
    IV infusion

Primary outcome measures

  • Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with ≥1 adverse event (AE) [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with significant changes in vital signs [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with significant changes in laboratory results [Time frame: Up to ~24 months]
  • Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation [Time frame: Up to ~24 months]
  • Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 [Time frame: Up to ~24 months]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination [Time frame: Up to ~36 months]
  • Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy [Time frame: Up to ~36 months]
  • Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy [Time frame: Up to ~36 months]
  • Expansion: Overall Survival (OS) with IMC-R117C Monotherapy [Time frame: Up to ~36 months]
  • Expansion: Percentage of participants with ≥1 Adverse Events (AE) [Time frame: Up to ~24 months]
  • Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE) [Time frame: Up to ~24 months]
  • Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings [Time frame: Up to ~24 months]
  • Expansion: Percentage of participants with significant changes in vital signs [Time frame: Up to ~24 months]
  • Expansion: Percentage of participants with significant changes in laboratory findings [Time frame: Up to ~24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 4 centers
  • Hospital HM Nou Delfos — Barcelona
  • VHIO, Vall d'Hebron University Hospital — Barcelona
  • Centro Integral Oncologico Clara Campal — Madrid
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid
Belgium · 3 centers
  • Institut Jules Bordet — Anderlecht
  • Universitair Ziekenhuis Gent — Ghent
  • UZ Leuven — Leuven
Australia · 2 centers
  • St Vincent's Hospital — Darlinghurst
  • Peter MacCallum Cancer Centre — Melbourne
Italy · 2 centers
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
  • nstituto Clinico Humanitas — Rozzano
Germany · 1 center
  • Universitaetsklinikum Heidelberg — Heidelberg
Netherlands · 1 center
  • Antoni van Leeuwenhoek — Amsterdam

Identifiers

NCT: NCT06840119 · IMC-R117C-1004 · 2023-508090-87-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗