Fig. 1: CONSORT diagram for STARPAC clinical trial.

Number of patients at all dose levels (DL) in dose escalation, part 1 (using the STARPAC adaptive trial design13) for maximum tolerated dose (MTD) estimation, showing dose-limiting toxicity (DLT) and dose expansion (part 2) of the trial for optimal biological dose (OBD) estimation leading to recommended phase 2 dose (RP2D).