Statistical analysis
toxicity, tumor
TUMOR
The planned maximum total number of patients exposed in module 1 was 140. The actual number of patients was determined by the number of dose escalations and patients enrolled in any of the backfill cohorts (up to eight each). This number was deemed sufficient to enable a better understanding of drug-related toxicity, at dose levels where the initial treatment effect was observed. Dose-escalation decisions were governed by the BOIN designAll safety and efficacy endpoints were summarized with descriptive statistics. Safety data were summarized using the safety population, which consisted of all patients who received at least one dose of RP-3500. The DLT rate was based on the DLT-evaluable population, which included those patients in dose-escalation cohorts (M1a and M1b only) receiving ≥80% of planned doses of camonsertib, who completed all required safety evaluations and were observed through the end of cycle 1 or patients who experienced a DLT. Due to the different number of dose levels expected and the exploratory nature of the phase 1 study, anti-tumor activity parameters were primarily based on patients who received ≥1 dose of RP-3500 and had ≥1 post-baseline tumor assessment by RECIST 1.1 and/or GCIG CA-125 or PCWG3 PSA criteria, with an initial dose level of >100 mg d