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Small Molecule Inhibitor

BDTX-1535 for Glioblastoma

1001, New York, NY

Targeting 12 different conditionsBDTX-1535 monotherapy +1 morePhase 1RecruitingResearch Sponsored by Black Diamond Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evaluable or measurable disease in dose escalation and measurable disease only for dose expansion cohorts.

Fulfills appropriate disease criteria as defined in Arms and Interventions

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthrough study completion, approximately 1 year

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new drug for people with glioblastoma or non-small cell lung cancer who have disease progression following standard of care.

Eligible Conditions

Glioblastoma
Epidermal Growth Factor Receptor Mutations
Solid Tumors
Non-Small Cell Lung Cancer
Cancer
Lung Cancer
Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You meet the requirements for having the medical condition that the study is testing.

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Your body's organs and bone marrow are working properly.

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You are expected to live for at least three more months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: Incidence of dose-limiting toxicities (DLTS) to estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BDTX-1535 as monotherapy.

Dose Expansion - Combination Treatment: Incidence of dose-limiting toxicities (DLTS) to estimate the MTD and/or the recommended phase 2 combination dose (RP2cD) of BDTX-1535 in combination with temozolomide for patients with newly diagnosed GBM.

Secondary outcome measures

Dose Escalation/Dose Expansion - Monotherapy and Combination Treatment: Incidence and severity of treatment-emergent adverse events (TEAEs)

Dose Escalation/Dose Expansion - Monotherapy: Area under the plasma concentration-time curve (AUC) of BDTX-1535 following single and multiple dosing.

Dose Escalation/Dose Expansion - Monotherapy: Elimination half-life (t1/2) of BDTX-1535 following single and multiple dosing.

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Escalation Cohorts - MonotherapyExperimental Treatment1 Intervention

Advanced/metastatic 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). Advanced/metastatic NSCLC with uncommon EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant)

Group II: Disease-Specific Dose Expansion Cohorts - MonotherapyExperimental Treatment1 Intervention

Advanced/metastatic 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) Advanced/metastatic NSCLC with intrinsic resistance EGFR mutation (eg, L858R, G719X) following standard-of-care therapy with an EGFR inhibitor Recurrent GBM with confirmed EGFR alterations with or without amplifications

Group III: Disease-Specific Dose Expansion Cohort - Combination TreatmentExperimental Treatment1 Intervention

• Newly diagnosed GBM (postsurgical resection and radiation therapy with temozolomide) harboring EGFR mutations or variants

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Black Diamond Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

231 Total Patients Enrolled

Black Diamond TherapeuticsStudy DirectorBlack Diamond Therapeutics

Media Library

BDTX-1535 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05256290 — Phase 1

Glioblastoma Research Study Groups: Dose Escalation Cohorts - Monotherapy, Disease-Specific Dose Expansion Cohorts - Monotherapy, Disease-Specific Dose Expansion Cohort - Combination Treatment

Glioblastoma Clinical Trial 2023: BDTX-1535 Highlights & Side Effects. Trial Name: NCT05256290 — Phase 1

BDTX-1535 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256290 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely dispersed is the current trial?

"The recruitment for this study is underway at 10 separate sites, including those located in Greenville, New York, and Nashville. Due to the necessity of follow-up visits it may be beneficial to choose a location close by when enrolling."

Answered by AI

Has the FDA sanctioned BDTX-1535 Monotherapy?

"Due to the dearth of evidence for safety and efficacy, BDTX-1535 Monotherapy has been rated a 1 on our assessment scale. This is in line with it being a Phase 1 trial."

Answered by AI

Are there any openings left for participants in this experiment?

"This medical endeavour, which was initially posted on March 31st 2022, is still recruiting participants as indicated by clinicaltrials.gov with the most recent update being released November 9th 2022."

Answered by AI

In what numbers are participants engaging in this clinical experiment?

"For this study to be a success, 90 qualified participants are needed. Patients interested in taking part can register at either 1013 Greenville (South Carolina) or 1001 New York City (New York)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

2022. "Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256290.

All > Lung Cancer Chicago > Glioblastoma Multiforme