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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519639-40-00 | EU Trial (CTIS) Number |
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This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm dose | Experimental | Phase 1a (escalation) Single arm dose escalation of TH9619 as monotherapy. Phase 1b (expansion) Single arm dose expansion of TH9619 as monotherapy in selected tumor types. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TH9619 | Drug | Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Frequency of serious adverse events (SAEs) | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol. | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. | |
| Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. | |
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Inclusion Criteria:
Exclusion Criteria:
• History or presence of any clinically significant disorders as judged by the Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Moody | Contact | +46708555182 | victoria.moody@one-carbon.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Recruiting | Villejuif | France | |||
| Vall D Hebron Institute Of Oncology |
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| Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator |
| From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of findings during physical examinations assessed as clinically significant by the Investigator | From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Incidence of treatment emergent adverse events (TEAEs) leading to dose interruptions/reductions and/or discontinuation of treatment | From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years. |
| Recruiting |
| Barcelona |
| Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
| Newcastle University | Recruiting | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
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