A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05120960
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a single center, multi-arm, biomarker-driven phase 1 study to assess the RP2D, PK/PD, safety, and activity of tepotinib in participants with MET alterations and brain tumors. Eligible patients include those with brain metastases or glioblastoma, including patients who are surgical candidates. In patients with EGFR+ NSCLC with EGFR-TKI resistance and MET amplification, tepotinib will be given in combination with osimertinib. This phase 1 study will be conducted in 2 parts, Phase 1a (dose exploration) and Phase 1b (dose expansion). Phase 1a will include a surgical resection window of opportunity component. Phase 1b (dose expansion) can open once the relevant RP2D has been estimated in Phase 1a (dose exploration). Phase 1a (Dose Exploration): Patients will be assigned to dose levels within a Group as outlined in the Statistical Analysis Plan. Group A will be comprised of patients who are surgical resection candidates with newly-diagnosed or recurrent brain metastases and MET alteration. Group B will be comprised of patients who are surgical resection candidates with recurrent glioblastoma and MET alteration. Group C will be comprised of patients with newly-diagnosed or recurrent brain metastases and epidermal growth factor receptor mutated (EGFR+) non-small cell lung cancer (NSCLC). Phase 1b (Dose Expansion): Upon completion of the Phase 1a (dose exploration) component and estimation of a RP2D, dose expansion may proceed within Group A (consisting of patients with brain metastasis and MET alteration) and Group C (EGFR+ NSCLC brain metastasis, TKI resistance, and MET amplification). Dose expansion in these 2 groups may be done concurrently, but enrollment in each group does not require completion of the entire Phase 1a component of the study. There will not be a Group B (glioblastoma) in Phase 1b. Patients in Phase 1b will not undergo surgical resection.

Key Dates

Start date
Feb 27, 2023
Status verified
Apr 2024
Primary completion
Apr 12, 2024
Completion
Apr 12, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    will receive tepotinib alone
  • Experimental: Group B
    will receive tepotinib and osimertinib

Primary Outcome Measure

To determine the recommended phase II dose (RP2D) of tepotinib for patients with brain metastasis and MET alterations (Group A) [ Time Frame: through study completion, an average of 1 year ]

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