CM93 Treatment in Subjects With Epidermal Growth Factor Receptor (EGFR)-Modified Recurrent Glioblastoma (rGBM)

Sponsor
Crimson Biopharm Inc.
Study ID
NCT04933422
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • CM93 — DRUG
    oral capsule of CM93 administered once daily

Study Details

This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. The trial objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical effects of CM93 in this patient population.

Key Dates

First listed
Jun 21, 2021
Start date
Jan 31, 2027
Status verified
Aug 2024
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CM93 pre-treatment arm
    Applicable only for part 3 of this trial (surgical window of opportunity), pre-treatment with CM93 prior to surgical resection of recurrent glioblastoma
  • No Intervention: No pre-treatment arm
    Applicable only for part 3 of this trial (surgical window of opportunity), no pre-treatment prior to surgical resection of recurrent glioblastoma

Primary Outcome Measure

Dose-limiting toxicities [ Time Frame: 28 days ]

Central Contacts

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