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BDTX-1535 for High-Grade Glioma and Glioblastoma with EGFR Alterations

This study is testing an investigational drug called BDTX-1535 in people with recurrent high-grade glioma (a type of brain cancer) or newly diagnosed glioblastoma (another type of aggressive brain cancer). BDTX-1535 is designed to block a specific growth signal that is important for some cancers, especially those with changes (alterations or fusions) in a protein called EGFR. Researchers want to see if BDTX-1535 can be given safely and how much of the drug reaches the tumor. The study will also look at how the drug affects the tumor. You may be eligible if you have these specific EGFR changes in your tumor.

Study design
This is a Phase 0/1 interventional study with a planned enrollment of 82 participants. It involves different treatment arms, including BDTX-1535 alone or combined with radiation therapy, or with temozolomide and radiation therapy.
What's involved
Participants in the Phase 0 part will receive BDTX-1535 before a planned tumor surgery, where blood, tumor, and spinal fluid samples will be collected. The study involves continuous treatment in 28-day cycles after initial therapy.
Compensation
Not stated in the trial record.
Follow-up
The incidence of dose-limiting toxicities (DLTs) will be measured from the day of the first dose to the end of concurrent radiation treatment at 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06072586

A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
St. Joseph's Hospital and Medical Center, Phoenix
~82 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:BDTX-1535BDTX-1535 combined with radiation therapyBDTX-1535 combined with temozolomide and radiation therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Unbound BDTX-1535 Concentration in Tumor Tissue
Measured over Intraoperative
+5 more outcomes measured

Conditions

High Grade Glioma
Glioblastoma

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GlioblastomaMalignant GliomaSoluble Epidermal Growth Factor Receptor

Where it's being run

2 sites across 1 states
Arizona2

Study leadership

  • Nader Sanai, MD · PRINCIPAL_INVESTIGATOR · Chief Scientific Officer/Director of the Ivy Brain Tumor Center

Who to contact

Phase 0 Navigator
[email protected]
602-406-8605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Arms A \& B: Recurrent high grade glioma (2021 WHO Grades 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.
Arm C, D, \& E: Newly diagnosed glioblastoma (2021 WHO Grade 4), who have not received any tumor directed intervention other than biopsy or resection.
Candidate for clinical resection of rHGG (Arms A \& B) or nGBM (Arms C \& D).
Adequate archival or biopsy tissue available for testing of EGFR alterations. The tissue must have evidence of EGFR alterations including variants, fusion, and mutations with or without amplifications. rHGG participants with EGFR fusion will be solely enrolled into Arm B.
Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
Provision of signed and dated, written informed consent (personally or by the legally authorized representative, if applicable) prior to any study specific procedures, sampling and analyses.
Age ≥ 18 at time of consent
Have a performance status (PS) of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Ability to swallow oral medications.
Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcL (at time of surgery)
Hemoglobin ≥ 8.5 g/dL (Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)
Total bilirubin ≤ 1.5 X ULN (Participants with Gilbert's syndrome with a total bilirubin ≤ 3.0 times ULN and direct bilirubin within normal limits are permitted.)
AST (SGOT) ≤ 3 X institutional ULN
ALT (SGPT) ≤ 3 X institutional ULN
Serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance ≥ 60 mL/min (calculated using Institutional standard method)
Participants on corticosteroids at baseline must be on stable or decreasing doses for at least 5 days prior to Day 1.
Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation until the end of treatment administration and for 16 weeks after the last dose of study drug.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner until the end of treatment administration and for 16 weeks after the last dose of study drug.
Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion

Pregnancy or breastfeeding.
Known allergic reactions to components of the BDTX-1535.
Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics or fever \>38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening of viral infection is not required for enrollment.
Significant cardiovascular disease, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, poorly controlled cardiac arrhythmias, or stroke in the preceding 6 months prior to study Day 1.
Symptomatic or radiographic leptomeningeal disease.
Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
Concurrent use of prohibited medications: coadministration of strong CYP2C8 and CYP3A4 inhibitors and inducers with BDTX-1535. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study Day 1. Strong inhibitors of P-gp (e.g., Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine, and verapami) and BCRP (e.g., curcumin, cyclosporin A, and eltrombopag) should be used with caution. Sensitive substrates of P-gp, BCRP, and OATP should also be used with caution.
Therapeutic intent treatment with another investigational drug or other intervention within 5 half-lives of the investigational product whichever is longer.
With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.

What this trial measures

  • Unbound BDTX-1535 Concentration in Tumor TissueIntraoperative

    Unbound BDTX-1535 concentration in Gd enhancing and Gd non-enhancing tumor tissue will be determined by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.

  • Total BDTX-1535 Concentration in Tumor TissueIntraoperative

    Total BDTX-1535 concentration in Gd enhancing and Gd non-enhancing tumor tissue will be determined by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.

  • Incidence of DLTs ObservedFrom day of first dose to the end of concurrent RT treatment at 10 weeks

    Considered DLTs: Hem toxicity: 8+ days ≥G4 neutropenia/febrile neutropenia; ≥G4, or ≥G3 with clinically significant bleeding, thrombocytopenia; ≥G3 anemia requiring transfusion. Non-hem lab abnormalities: Any AR ≥G3 of ALT/AST or increase in ALT/AST \>3x ULN with concurrent increase in total bilirubin \>2x ULN (per Hy's Law) in pt with baseline \<G1 ALT/AST; Any AR ≥G3 of ALT/AST \>2x baseline or 10x ULN in pt with baseline \>G2 ALT/AST due to liver mets; Non-hem dose limiting toxicity ≥G3 (per Investigator; except for G3 nausea, vomiting, or diarrhea lasting \<72 hrs with adequate antiemetic/supportive care; G3 fatigue or anorexia lasting \<1 week; ≥G3 electrolyte abnormality lasting up to 72 hrs, isn't clinically complicated, and resolves spontaneously or responds to intervention). AR requiring dose reduction in C1, causes \>2 week delay of C2, causes 8+ day dose interruption in C1. DLTs exclude: alopecia; lymphopenia; isolated lab changes w/o clinical sequelae or significance

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI-CTCAE v5Day of first dose until 30 days after final day of participation

    AEs that occur while participants are on study treatment.

  • Number of Participants with Treatment-Related Adverse Events (TRAEs) as Assessed by NCI-CTCAE v5Day of first dose until 30 days after final day of participation

    Causality will be graded using these categories: definitely related, probably related, potentially related, unlikely to be related, and not related. Causality will be assessed by the clinician who examines and evaluates the participant based on temporal relationship and their clinical judgment. The Medical Monitor will also provide causal relationship for any Serious Adverse Events (SAEs).

  • Number of Participants with Abnormal Laboratory Values as Assessed per NCI-CTCAE v5Day of first dose until 30 days after final day of participation

    Significant changes from participant's baseline established during screening.