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P1 data, Journal, Metastases: Phase Ia dose-escalation trial with the BET protein inhibitor BI 894999 in patients with advanced or metastatic solid tumours. (Pubmed Central) - Aug 9, 2023 P1a/1b The 1.5, 2.5, and 6.0/3.0?mg doses in Schedules A, B, and C, respectively, were declared as maximum tolerated dose. Based on the strength of these data, BI 894999 was further evaluated in a Phase Ib trial.
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MEKi-based combination strategies for targeting KRAS-driven cancer (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_289; We also combine BI 3011441 with BI 1701963 and BI 894999 - two potent, selective, and orally bioavailable inhibitors of SOS1 and BET, respectively. In summary, we show that combining BI 3011441 with SOS1 or BET inhibitors may lead to improved responses in KRAS mutant tumors, likely by circumventing MAPK pathway-related adaptive resistance.
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Journal: Therapeutic impact of BET inhibitor BI 894999 treatment: backtranslation from the clinic. (Pubmed Central) - Aug 6, 2022 In summary, we show that combining BI 3011441 with SOS1 or BET inhibitors may lead to improved responses in KRAS mutant tumors, likely by circumventing MAPK pathway-related adaptive resistance. BI 894999 holds significant potential as a combination drug and CCS1477 p300/CBP inhibitor is a promising partner for future clinical trials.
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Trial completion, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - Dec 6, 2021 P1a/1b, N=174, Completed, Our study suggests that pre-existing heterogeneous subclones with epigenetic plasticity contribute to escaping direct KRAS inhibition in pancreatic cancer and provides a new avenue to overcome such resistance by combining KRAS inhibitors with BET inhibitors. Active, not recruiting --> Completed
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Trial completion date, Trial primary completion date, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - May 20, 2021 P1a/1b, N=204, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Aug 2022 --> Dec 2021 | Trial primary completion date: Jul 2022 --> Nov 2021
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Trial primary completion date, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - May 12, 2021 P1a/1b, N=204, Recruiting, Trial completion date: Aug 2022 --> Dec 2021 | Trial primary completion date: Jul 2022 --> Nov 2021 Trial primary completion date: Apr 2018 --> Jul 2022
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[VIRTUAL] SMAC mimetic and BET inhibitor - a promising combination for solid cancer treatment? () - Mar 13, 2021 - Abstract #AACR2021AACR_4700; P1, P1a/1b These preclinical in vitro and in vivo data are highlighting the potential of a SMACm/BETi combination for the treatment of solid cancers. The identification of patient selection markers for this combination will be necessary for advancing this concept into pivotal clinical trials.
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Trial completion date, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - May 7, 2020 P1a/1b, N=176, Recruiting, The identification of patient selection markers for this combination will be necessary for advancing this concept into pivotal clinical trials. Trial completion date: May 2022 --> Aug 2022
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Biomarker, Preclinical, Journal: Synergistic activity of BET inhibitor BI 894999 with PLK inhibitor volasertib in AML in vitro and in vivo. (Pubmed Central) - May 7, 2019 Co-administration of BI 894999 and volasertib dramatically reduces tumor burden accompanied by long-term survival of tumor-bearing mice and eradication of AML cells in mouse bone marrow. Together, these preclinical findings provide evidence for the strong synergistic effect of BI 894999 and volasertib, warranting future clinical studies in patients with AML to investigate this paradigm.
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Trial completion date, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - Aug 21, 2018 P1a/1b, N=143, Recruiting, Together, these preclinical findings provide evidence for the strong synergistic effect of BI 894999 and volasertib, warranting future clinical studies in patients with AML to investigate this paradigm. Trial completion date: Nov 2019 --> May 2021
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Enrollment open, Enrollment change, Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - Jun 23, 2017 P1a/1b, N=143, Recruiting, Trial primary completion date: Jan 2018 --> Mar 2018 Active, not recruiting --> Recruiting | N=28 --> 143 | Trial primary completion date: Oct 2016 --> Oct 2017 | Active, not recruiting --> Recruiting | N=28 --> 143
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Metastases: BI 894999 First in Human Dose Finding Study in Advanced Malignancies (clinicaltrials.gov) - Jan 12, 2017 P1a/1b, N=28, Active, not recruiting, Active, not recruiting --> Recruiting | N=28 --> 143 | Trial primary completion date: Oct 2016 --> Oct 2017 | Active, not recruiting --> Recruiting | N=28 --> 143 N=143 --> 28 | Trial primary completion date: May 2017 --> Oct 2016
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