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A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. (MasterKey-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209465
Recruitment Status : Terminated (The development of BDTX-189 was discontinued by the sponsor.)
First Posted : December 24, 2019
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Black Diamond Therapeutics, Inc.

Results Submitted - Quality Control (QC) Review Has Not Concluded
Results information for an applicable clinical trial (ACT) is posted within 30 days of submission even if the submission has not completed the ClinicalTrials.gov Results Quality Control (QC) review process. Results information is submitted to ClinicalTrials.gov by the sponsor or investigator, and National Library of Medicine (NLM) staff assess for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

All versions of ACT results information submissions that have not completed the QC review process are posted on ClinicalTrials.gov (since January 2020). After the QC review process is completed, the results information is posted without QC review comments and previous versions are archived.

Recruitment Status : Terminated
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : September 16, 2022
Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 August 25, 2023
September 21, 2023 Submission with QC Comments
2 October 13, 2023
April 5, 2024
3 April 17, 2024
 
Publications:
Erika Paige Hamilton, Manish R. Patel, Jordi Rodon, David S. Hong, Alison M. Schram, Pasi A. Janne, Patricia LoRusso, Jasgit C. Sachdev, Sai Hong Ou, Elizabeth A Buck, Matthew O'Connor, Nigel Waters, Karsten Witt, Carl Cook. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. J Clin Oncol 38: 2020 (suppl; abstr TPS3665)