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Association details:
| Biomarker: | DLL3 positive |
|---|---|
| Cancer: | Neuroendocrine Tumor |
| Drug: | BI 764532 (CD3 agonist, DLL3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
725MO - Phase I trial of the DLL3/CD3 IgG-like T cell engager BI 764532 in patients (pts) with DLL3-positive (+) tumours: Focus on neuroendocrine carcinomas
Published date:
10/16/2023
Excerpt:
In the efficacy population, there were 46 pts with epNEC (gastrointestinal: n=23; genitourinary: n=16; unknown origin: n=7). ORR/DCR was 22/41%. In pts who received clinically active doses of BI 764532 (n=36), ORR/DCR was 28/47%...BI 764532 showed clinically manageable tolerability...Promising efficacy was observed in pts with epNEC.
Trial ID:
Source:
Title:
First-in-human dose-escalation trial of BI 764532, a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager in patients (pts) with DLL3-positive (DLL3+) small-cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC).
Published date:
05/31/2023
Excerpt:
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.
DOI:
10.1200/JCO.2023.41.16_suppl.8502
Trial ID:
Source:
Title:
First-in-human dose-escalation trial of BI 764532, a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager in patients (pts) with DLL3-positive (DLL3+) small-cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC).
Published date:
05/25/2023
Excerpt:
...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.
DOI:
10.1200/JCO.2023.41.16_suppl.8502
Trial ID:
