Drugs / DZD1516
last change Jul 2023 re-read 9 days ago

DZD1516

Developed for
breast cancer
Investigated by
Dizal Pharmaceuticals

Trials 1

202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT04509596 Sep 2020 → Jul 2022 breast cancer Dizal Pharmaceuticals Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2023-07-09 Dizal Pharmaceuticals Results Dizal Announces Pre-clinical and Early Clinical Results of DZD1516 in Breast Cancer Research dizalpharma.com ↗
Dizal today announced the latest publication of translational science and early clinical results of DZD1516, a potent andselective HER2 tyrosine kinase inhibitor (TKI) with full brain blood barrier (BBB) penetration in Breast Cancer Research (IF: 8.4).
2022-12-09 Dizal Pharmaceuticals Results 2022 SABCS| Dizal Announces Updated Results from Phase I Trial Evaluating DZD1516 in Heavily Pretreated Metastatic HER2 Positive Metastatic Breast Cancer dizalpharma.com ↗
Among 21 evaluable patients who completed at least one post-treatment assessment per modified RECIST v1.1 criteria, the best anti-tumor response achieved with the oral HER2-targeted TKI was stable disease in intracranial, extracranial, and overall lesions.
2022-11-02 Dizal Pharmaceuticals Results Dizal to Present Latest Scientific Advancements across its Fast-growing Innovative Pipeline at 2022 CSCO dizalpharma.com ↗
With a median of 7 lines of prior systemic treatment (86% treated with HER2 TKI), the best antitumor efficacy in intracranial, extracranial and overall lesions was stable disease.
2022-09-05 Dizal Pharmaceuticals Results Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO dizalpharma.com ↗
DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported.
2022-05-27 Dizal Pharmaceuticals Results Dizal to Demonstrate the Strength and Rapid Acceleration of its Clinical Portfolio at ASCO 2022 dizalpharma.com ↗
Results from the Phase 1 trial, which is evaluating the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer, showed DZD1516 was well tolerated at doses < 300mg, BID.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as DZD1516 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04509596 ↗
Action Inhibit “DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor.” NCT04509596 ↗
Route Oral “Part A is twice daily (except Cycle 0) oral dosing of DZD1516, starting from 50 mg.” NCT04509596 ↗