Fig. 1: Study design. | Nature Medicine

Fig. 1: Study design.

From: SEZ6-targeting antibody−drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial

Fig. 1: Study design.The alternative text for this image may have been generated using AI.

a, Study schema. CONSORT diagram disposition of all patients who received monotherapy comprising the safety analysis population (b) and of those in the dose-optimization cohorts who were included in the primary efficacy and RP2D analysis (c). This phase 1, open-label, dose-escalation and dose-expansion study of ABBV-706 in patients with advanced solid tumors with potential SEZ6 expression comprised four parts: part 1 was dose escalation of ABBV-706 monotherapy and included all advanced solid tumors; part 2 (a, b and c) was dose optimization/expansion of ABBV-706 monotherapy in R/R SCLC; and part 4 was dose expansion of ABBV-706 monotherapy in R/R CNS tumors (4a) and high-grade NENs (4b). Data from part 3 (ABBV-706 combination therapy) are not reported. aIV Q3W in 21-day cycles until disease progression or unacceptable toxicity. bPart 2b was not pursued. cOne patient in this cohort was ineligible. dThe totality of efficacy, safety and PK data from part 1 and part 2 confirmed 1.8 mg kg−1 as the optimal dose for patients with R/R SCLC. en = 30 patients were screened and enrolled in the ABBV-706 plus budigalimab combination cohorts, which are not reported here. f Part 3b was halted after enrollment of 18 patients; data from this cohort are not reported here. BOIN, Bayesian optimal interval; ES, extensive stage; IV, intravenous.

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