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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508090-87-00 | Other Identifier | EU CTR |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: IMC-R117C Monotherapy Dose-Escalation | Experimental | Participants receive IMC-R117C intravenous (IV) infusion. |
|
| Arm B: IMC-R117C Combination Dose-Escalation | Experimental | Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent |
|
| Arm C: IMC-R117C Combination Dose-Escalation | Experimental | Participants receive IMC-R117C IV infusion with targeted therapies |
|
| Arm D: Control Arm | Active Comparator | Participants receive standard of care chemotherapy and antiangiogenic agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-R117C | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) | Up to ~24 months | |
| Dose Escalation: Percentage of participants with ≥1 adverse event (AE) | Up to ~24 months | |
| Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) | Up to ~24 months | |
| Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings | Up to ~24 months | |
| Dose Escalation: Percentage of participants with significant changes in vital signs | Up to ~24 months | |
| Dose Escalation: Percentage of participants with significant changes in laboratory results | Up to ~24 months | |
| Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation | Up to ~24 months | |
| Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 | Up to ~24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination | Up to ~36 months | |
| Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Immunocore Medical Information | Contact | 844-466-8661 | medical.information@immunocore.com | |
| Immunocore Medical Information EU | Contact | +00 800-744-51111 | medinfo.eu@immunocore.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Active, not recruiting | Darlinghurst | Sydney | NSW 2010 | Australia | |
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The study will include sequential assignment for non-randomized and randomized arms.
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| Chemotherapy drug | Drug | IV infusion |
|
| Chemotherapy drug | Drug | oral |
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| Kinase inhibitor | Drug | oral |
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| Antiangiogenic Agent | Drug | IV infusion |
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| Monoclonal antibody | Drug | IV infusion |
|
| Up to ~36 months |
| Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination | Up to ~36 months |
| Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination | Up to ~36 months |
| Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy | Up to ~36 months |
| Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy | Up to ~36 months |
| Expansion: Overall Survival (OS) with IMC-R117C Monotherapy | Up to ~36 months |
| Expansion: Percentage of participants with ≥1 Adverse Events (AE) | Up to ~24 months |
| Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE) | Up to ~24 months |
| Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings | Up to ~24 months |
| Expansion: Percentage of participants with significant changes in vital signs | Up to ~24 months |
| Expansion: Percentage of participants with significant changes in laboratory findings | Up to ~24 months |
| Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation | Up to ~24 months |
| All Study: Plasma Concentration of IMC-R117C | Up to ~36 months |
| All Study: Incidence of anti-IMC-R117C Antibody Formation | Up to ~36 months |
| All Study: Incidence of tumor expression and localization of PIWIL1 | Up to ~36 months |
| Peter MacCallum Cancer Centre |
| Recruiting |
| Melbourne |
| Australia |
| Institut Jules Bordet | Recruiting | Anderlecht | 1070 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | Germany |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | Italy |
| nstituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | Netherlands |
| Hospital HM Nou Delfos | Recruiting | Barcelona | Spain |
| VHIO, Vall d'Hebron University Hospital | Recruiting | Barcelona | Spain |
| Centro Integral Oncologico Clara Campal | Recruiting | Madrid | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020533 | Angiogenesis Inhibitors |
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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