NCT04429087 is an ongoing phase I dose-escalation trial of BI 764532, a DLL3/CD3 IgG-like T-cell engager, in pts with locally advanced/metastatic DLL3+ SCLC, extrapulmonary (ep) NEC or large cell NEC of the lung (LCNEC)....Overall, ORR in pts who received clinically active doses of BI 764532 (n=71) was 25% (SCLC 26%; epNEC 19%; LCNEC 60%). In Asian pts who received clinically active doses (n=13), ORR was 23%....BI 764532 showed manageable tolerability; MTD has not been reached. Promising efficacy was observed in SCLC, epNEC and LCNEC. The tolerability and efficacy of BI 764532 was similar in Asian pts and the overall population.

NCT04429087 is an ongoing phase I first-in-human, open-label, dose-escalation trial of BI 764532 in adults with locally advanced/metastatic DLL3+ (confirmed centrally) SCLC, NEC or small cell carcinoma of any other origin (grouped as NEC), or large cell NEC (LCNEC)....In pts with SCLC (n = 24) or NEC (n = 23) who received ≥ target dose of BI 764532, ORR was 33% and 22% across all regimens, respectively. One pt with LCNEC was also evaluable for response and achieved PR.

...dose-escalation trial of BI 764532 in adults with locally advanced/metastatic DLL3+ (confirmed centrally) SCLC, NEC or small cell carcinoma of any other origin (grouped as NEC), or large cell NEC (LCNEC)....Tumor response data were available for 70 pts (RA/RB1/RB2: n = 19/8/43). In pts with SCLC (n = 24) or NEC (n = 23) who received ≥ target dose of BI 764532, ORR was 33% and 22% across all regimens, respectively. One pt with LCNEC was also evaluable for response and achieved PR....Promising efficacy has been observed, not only in SCLC but also in difficult to treat entities such as NEC and LCNEC.