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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Oral capsules
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Number of participants with any treatment-emergent (TE) serious adverse event (SAE)
Time frame: a minimum of approximately 3 months
Number of participants with any non-serious TEAE
Time frame: a minimum of approximately 3 months
Number of participants with grade 3, grade 4, or grade 5 TEAEs
Time frame: a minimum of approximately 3 months
Number of participants with any related TEAE
Time frame: a minimum of approximately 3 months
Number of participants with any TEAE leading to study drug discontinuation
Time frame: a minimum of approximately 3 months
Maximum tolerated dose (MTD) of BOS172738
Time frame: throughout Cycle 1 (each cycle is 28 days)
Recommended phase 2 dose (RP2D) of BOS172738
Time frame: 28-day cycles in Part A (minimum of one dose of BOS172738 received)
Objective Response Rate (ORR)
Time frame: a minimum of approximately 3 months
Objective Disease Control Rate (ODCR)
Time frame: a minimum of approximately 3 months
Progression-Free Survival (PFS)
Time frame: a minimum of approximately 3 months
Duration of Response (DoR)
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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
...and 11 more locations
Time frame: a minimum of approximately 3 months
Time to Response (TTR)
Time frame: a minimum of approximately 3 months
Duration of Complete Response (DoCR)
Time frame: a minimum of approximately 3 months
Part A: Plasma concentration of BOS172738
Time frame: 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
Time frame: Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days)