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NSCLC / EGFR Clinical Trial: BDTX-1535


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Contact Katie Tith with any questions about this study: ktith@bdtx.com

BDTX-1535 is an orally available, highly potent, selective, irreversible inhibitor of allosteric epidermal growth factor receptor (EGFR) alterations, including amplification, mutations, and splice variants which have been identified in glioblastoma (GBM) and mutations in non-small cell lung cancer (NSCLC) associated with intrinsic or acquired resistance. The open label, multicenter will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BDTX-1535 in patients with GBM harboring EGFR alterations and NSCLC with EGFR mutations of intrinsic or acquired resistance who have failed standard treatment. Dose escalation cohorts will be used to determine the maximum tolerated dose and recommended phase 2 dose of BDTX-1535 oral administration.

Patients with NSCLC must meet all of the following inclusion criteria, in addition to the common inclusion criteria applicable for all patients:
•    Histologically or cytologically confirmed NSCLC, without small cell lung cancer transformation.
•    Locally advanced or metastatic disease, with or without CNS metastases.
•    Disease may be evaluable or measurable for dose escalation cohorts but must be measurable by RECIST v1.1 criteria for enrollment on the disease specific expansion cohorts.
•    Disease progression following or intolerance of standard of care:
-    NSCLC with uncommon EGFR mutations (eg, G719X), following standard of care therapy with an EGFR inhibitor.
-    NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M).
•    EGFR mutations identified by NGS in the absence of other known resistance mutations (eg, T790M, MET)

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  • 7 months later...

Good day 
I am in the trial and dose 75 mg 
I broke out with skin issues after dose was increased to 100 mg, now redused to 75 and tumors are responding positive however skin us still breaking out in various places. 

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  • 4 weeks later...

Good day, 

the break outs were getting bad and the dr agreed so we stopped trial for one week and the breakouts were healing a bit. So on to the trial once again (75 mg ) instead of 100 and the healing seems to continue but breakouts are still visible and funky. But hoping for the best. 
It beats the alternative no? 

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