This study will be conducted to assess the safety and tolerability of BOS172722 when administered as monotherapy and in combination with paclitaxel in participants with advanced nonhaematologic malignancies and also to establish the maximum tolerated dose and recommended Phase 2 dose of BOS172722 in combination with paclitaxel in those participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Oral capsules
IV infusion
Addenbrooks Hospital
Cambridge, United Kingdom
Edinburgh Cancer Centre - Western General Hospital
Edinburgh, United Kingdom
Royal Marsden
London, United Kingdom
Incidence of adverse events (AEs)
An AE is any untoward medical occurrence and does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product (IP), whether or not related to the IP. AEs include pre-existing conditions that worsen.
Time frame: a minimum of approximately 3 months
Number of participants with a dose-limiting toxicity (DLT)
A DLT is defined as any toxicity attributable to BOS172722 that occurs before the end of Cycle 1.
Time frame: Cycle 1 (28 days)
Part A Monotherapy: Plasma concentration of BOS172722 measured over 24 hours when administered alone
The plasma concentration of BOS172722 when administered as monotherapy will be characterized
Time frame: Cycle 1: Day 1
Part A Combination: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered either individually or in combination
The plasma concentration of BOS172722 and paclitaxel will be characterized.
Time frame: Cycle 0: Day 1; Cycle 1: Day 1; Cycle 2: Day 1
Part B Expansion: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered in combination
The plasma concentration of BOS172722 and paclitaxel will be characterized.
Time frame: Cycle 1: Days 1 and 8 or 15
Objective response rate (ORR)
ORR is defined as the percentage of participants achieving the best overall response of confirmed partial response (PR) or complete response (CR), as determined by investigator review. Responses are assessed by the Investigators using Response Evaluation Criteria in Solid Tumours (RECIST) guideline version 1.1.
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Time frame: a minimum of approximately 3 months
Duration of response (DOR)
DOR is defined as the time from documentation of tumor response to disease progression. Responses are assessed by the Investigators using RECIST guideline version 1.1.
Time frame: a minimum of approximately 3 months
Time to response (TTR)
TTR is defined as the time from the start of treatment to the first objective tumor response observed for participants who achieved a CR or PR. Responses are assessed by the Investigators using RECIST guideline version 1.1.
Time frame: a minimum of approximately 3 months
Time to progression on study
Time to progression is defined as the time from treatment until objective tumor progression. This does not include deaths. Responses are assessed by the Investigators using RECIST guideline version 1.1.
Time frame: a minimum of approximately 3 months