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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002612-27 | EudraCT Number |
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This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOS172738 | Experimental | In Part A (dose escalation), participants with advanced solid tumors with rearranged during transfection (RET) gene alterations will receive oral BOS172738 at a starting dose of 10 milligrams (mg) once daily in each 28-day cycle. In Part B (dose expansion), participants with RET gene-fusion non-small cell lung cancer (NSCLC), with RET gene-mutant medullary thyroid cancer (MTC), and with RET gene-altered advanced tumors or NSCLC/MTC with prior specific RET gene-targeted therapy will be enrolled in Cohorts 1, 2, and 3, respectively, and will receive oral BOS172738 once daily in each 28-day cycle at the recommended Phase 2 dose (RP2D) established in Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOS172738 | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any treatment-emergent (TE) serious adverse event (SAE) | a minimum of approximately 3 months | |
| Number of participants with any non-serious TEAE | a minimum of approximately 3 months | |
| Number of participants with grade 3, grade 4, or grade 5 TEAEs | a minimum of approximately 3 months | |
| Number of participants with any related TEAE | a minimum of approximately 3 months | |
| Number of participants with any TEAE leading to study drug discontinuation | a minimum of approximately 3 months | |
| Maximum tolerated dose (MTD) of BOS172738 | throughout Cycle 1 (each cycle is 28 days) | |
| Recommended phase 2 dose (RP2D) of BOS172738 | 28-day cycles in Part A (minimum of one dose of BOS172738 received) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | a minimum of approximately 3 months | |
| Objective Disease Control Rate (ODCR) | a minimum of approximately 3 months | |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| MD Anderson Cancer Center |
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| a minimum of approximately 3 months |
| Duration of Response (DoR) | a minimum of approximately 3 months |
| Time to Response (TTR) | a minimum of approximately 3 months |
| Duration of Complete Response (DoCR) | a minimum of approximately 3 months |
| Part A: Plasma concentration of BOS172738 | Pre-dose on Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, and 4. 15 minutes (min); 30 min; 1, 3, 6, 8, 10, and 12 hours after the BOS1722722 dose on Days 1 and 15 of Cycle 1 (each cycle is 28 days) |
| Part B: Plasma concentration of BOS172738 | Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days) |
| Houston |
| Texas |
| 77030 |
| United States |
| Institut Jules Bordet | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| Institut Bergonié | Bordeaux | France |
| Centre Léon Bérard | Lyon | France |
| Hôpital Pitié-Salpêtrière | Paris | France |
| Institut Gustave Roussy | Villejuif | France |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University College of Medicine | Seoul | South Korea |
| Hospital Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital Germans Trias i Pujol | Badalona | Spain |
| Instituto Oncológico Dr. Rosell, S.L. | Barcelona | Spain |
| Start Madrid - Ciocc | Madrid | Spain |
| START MADRID-FJD, Hospital Fundación Jiménez Díaz | Madrid | Spain |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| ID | Term |
|---|---|
| D018813 | Multiple Endocrine Neoplasia Type 2a |
| D018276 | Carcinoma, Medullary |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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