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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

StatusRecruiting
PhaseEarly Phase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from St. Joseph's Hospital and Medical Center, Phoenix

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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 1 of 2 sites
  2. Primary completion date: Sep 2026 to Dec 2026
    • Study completion date: Sep 2027 to Dec 2027
    v8
  3. Study title expanded, about 8 wordsv7
  4. Enrollment target: 34 to 82v6 Show 9 more changesShow less
    • Primary completion date: May 2025 to Sep 2026
    • Primary endpoints: 3 to 6
    • Study completion date: Oct 31, 2025 to Sep 2027
    • Interventions: BDTX-1535 (Drug) to BDTX-1535 (Drug), BDTX-1535 combined with radiation therapy (Drug), BDTX-1535 combined with temozolomide and radiation therapy (Drug)
    • Eligibility criteria expanded, about 623 words
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 23 words
    • Site contacts updated at 2 of 2 sites
    • Study arms: 2 to 5
  5. Study sites: 1 to 2v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site contact updatedv4
  2. Enrollment target: 22 to 34
    • Secondary endpoints: details revised at 1 of 7 entries
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 27, 2023 to Oct 18, 2023
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Unbound BDTX-1535 Concentration in Tumor Tissue
Timeframe: Intraoperative
Total BDTX-1535 Concentration in Tumor Tissue
Timeframe: Intraoperative
Incidence of DLTs Observed
Timeframe: From day of first dose to the end of concurrent RT treatment at 10 weeks
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI-CTCAE v5
Timeframe: Day of first dose until 30 days after final day of participation
Number of Participants with Treatment-Related Adverse Events (TRAEs) as Assessed by NCI-CTCAE v5
Timeframe: Day of first dose until 30 days after final day of participation
Number of Participants with Abnormal Laboratory Values as Assessed per NCI-CTCAE v5
Timeframe: Day of first dose until 30 days after final day of participation

Secondary (6)

BDTX-1535 Concentration in CSF
Change in pEGFR Expression in Tumor Tissue
Change in pERK Expression in Tumor Tissue
6-Month Progression Free Survival (PFS6) Rate
Median Progression Free Survival (PFS)
Show 1 moreShow less
Median Overall Survival (OS)

Arms and interventions

Arm A: Recurrent High-Grade Glioma Participants with EGFR AlterationsExperimental

Phase 0: Cohort 1 will receive 200 mg BDTX-1535 once daily (Days 1-5). Cohort 2 will receive 400 mg BDTX-1535 three times over one week (Days 1, 3, and 5). The final dose will be administered 2-4 hours before tumor resection on Day 5. Phase 1: Participants will received 200 mg BDTX-1535 treatment once daily, continuously in 28-day cycles after surgery. Participants will receive BDTX-1535 until disease progression, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Arm B: Recurrent High-Grade Glioma Participants with EGFR FusionExperimental

Phase 0: Participants will received BDTX-1535 once daily (Days 1-5). The dose level will be determined based on PK results from Arm A, unbound drug concentration in non-enhancing tumor. The final dose will be administered 2-4 hours before tumor resection on Day 5. Phase 1: Participants will received 200 mg BDTX-1535 treatment once daily, continuously in 28-day cycles after surgery. Participants will receive BDTX-1535 until disease progression, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Arm C: Newly-Diagnosed GBM Participants with EGFR Alterations (OBD Determination)Experimental

Phase 0: Participants in Cohort 1 will receive 200 mg of BDTX-1535 once daily for 5 days, and participants in Cohort 2 will receive 150 mg of BDTX-1535 once daily for 5 days. The final dose will be administered 2-4 hours before tumor resection on Day 5. . Participants with unmethylated MGMT promoter tumors demonstrating PK response will proceed to the Phase 1 Expansion component. The OBD will be the lowest dose that achieves the following: 9 of 12 participants show PK response and 6 of 12 participants show PD response. Phase 1: Participants with unmethylated MGMT promoter tumors demonstrating a PK response will continue BDTX-1535 treatment at the same dose received during Phase 0, concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT. Participants will receive BDTX-1535 until disease progression, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Arm D: Newly-Diagnosed GBM Participants with EGFR Alterations (BDTX-1535 + RT Safety)Experimental

Phase 0: Participants will receive the OBD of BDTX-1535 once daily for 5 days. The final dose will be administered 2-4 hours before tumor resection on Day 5. Participants with unmethylated MGMT promoter tumors demonstrating PD response will proceed to the Phase 1 Expansion component. Phase 1: Arm D: Participants with unmethylated MGMT promoter tumors demonstrating a PD response will continue BDTX-1535 treatment at the same dose received during Phase 0, concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT. Participants will receive BDTX-1535 until disease progression, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Arm E: Newly-Diagnosed GBM Participants with EGFR Alterations (Stupp protocol)Experimental

Phase 0: Participants will receive the OBD of BDTX-1535 once daily for 5 days. The final dose will be administered 2-4 hours before tumor resection on Day 5. Participants with methylated MGMT promoter tumors demonstrating PD response will proceed to the Phase 1 Expansion component. Phase 1: Participants with methylated MGMT promoter tumors demonstrating a PD response will continue BDTX-1535 treatment at the same dose received during Phase 0, concurrently with standard of care upfront RT and temozolomide (TMZ), followed by adjuvant BDTX-1535 combined with standard of care TMZ continuously in 28-day cycles after RT. Participants will receive BDTX-1535 until disease progression, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.

Drugs: BDTX-1535, BDTX-1535 combined with radiation therapy, BDTX-1535 combined with temozolomide and radiation therapy

Sites

2 sites in 1 country