Lung Cancer Clinical Trial
Study of BDTX-1535, in Participants With Glioblastoma or Non-Small Cell Lung Cancer
This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care
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
Common Inclusion Criteria Required for ALL Patients
All patients must meet the common inclusion criteria required for all patients AND the respective criteria required for their specific disease for GBM and NSCLC (as applicable):
Adults 18 years of age or older (at the time of providing informed consent)
Patients with GBM or NSCLC who meet the disease-specific criteria and have disease progression after treatment with available therapies that are known to confer clinical benefit, or who refuse or are intolerant to treatment.
Adequate bone marrow or organ function as demonstrated by all the following laboratory values:
Estimated (using the Cockcroft-Gault equation) or measured creatinine clearance ≥ 60 mL/min.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3 × ULN. AST or ALT ≤5.0 × ULN in the presence of liver metastases.
Total bilirubin <1.5 × ULN (for patients with Gilbert's syndrome, bilirubin <3.0 × ULN is allowed).
Absolute neutrophil count (ANC) >1000 cells/μL
Hemoglobin >8.5 g/dL. (Note: transfusion is allowed up to 1 week prior to enrollment)
Platelet count >100,000/μL. (Note: transfusion is allowed up to 1 week prior to enrollment)
Inclusion Criteria Required for GBM Patients Only
In addition to the common inclusion criteria above, patients with GBM must also meet the following inclusion criteria:
Histologically confirmed diagnosis of GBM according to 2021 WHO criteria IDHwt (wild-type IDH) GBM and astrocytoma with molecular features of GBM).
A radiological diagnosis of recurrent disease following available standard of care therapy of surgery, radiation, and/or TMZ. Disease may be evaluable or measurable for dose escalation cohorts but must be measurable by RANO criteria for enrollment on the disease specific expansion.
Tumor evidence of EGFR alterations including amplification, variants, or mutations as determined in a local laboratory by NGS, RNAseq, FISH, IHC, or Array GCH
Inclusion Criteria Required for NSCLC Patients Only:
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)
Common Exclusion Criteria Required for ALL Patients:
Known resistant mutations in tumor tissue or ctDNA, including EGFR T790M, EGFR exon 20 insertion mutations, MET (including MET amplification), KRAS, or HER2 (C805S, T798I, or T862A)
GBM patient treated with a prior EGFR inhibitor
Symptomatic Leptomeningeal disease. Asymptomatic untreated CNS and leptomeningeal disease is allowed and, when measurable, should be captured as target lesions
Symptomatic brain metastases or spinal cord compression requiring increasing corticosteroids or urgent clinical intervention
Unresolved Grade 2 or greater toxicity from prior therapy
Significant cardiovascular disease
Clinically significant abnormal electrocardiogram (ECG) findings
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There are 15 Locations for this study
Denver Colorado, 80218, United States
Miami Florida, 33176, United States
Boston Massachusetts, 02115, United States
New York New York, 10021, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Fairfax Virginia, 22031, United States
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 10408, Korea, Republic of
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