A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
- Study HIC#:2000030687
- Last Updated:06/14/2022
This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.
- Start Date06/13/2022
- End Date01/01/2024
Trial Purpose and Description
Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of two dosing schedules of CBX-12 will be evaluated. Subjects in Part A will be treated with CBX-12 on a daily x 5 every 3 weeks schedule. Subjects in Phase 1 Part B will be treated with CBX-12 on a daily x 3 every 3 weeks schedule. Once at least 2 cohorts in Part A have been evaluated for safety through the dose-limiting toxicity (DLT) period and the Safety Review Committee (SRC) has reviewed the safety and available PK data for the completed Part A cohorts, the first cohort in Part B may open for accrual. The initial dose in Part B will be determined based on the safety and tolerability of Part A subjects to that point.
Once the recommended phase 2 dose (RP2D) has been established in both Part A and Part B, Phase 2 expansion cohorts may open.
Key Inclusion Criteria:
- Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
- Has measurable disease per RECIST 1.1.
- An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
- Agrees to an on-treatment biopsy preferably of the same lesion from which the pre-CBX-12 treatment sample was obtained as long as the Investigator determines such biopsy can be performed with acceptable safety.
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be reduced to 2 weeks for bone only radiation therapy or investigational agents not expected to be associated with adverse events (AEs) after 2 weeks of last administration, with Medical Monitor approval.
- Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days prior to the first dose of CBX-12.
- Subjects who are currently receiving any other anti cancer or investigational agent(s).
- Clinically significant intercurrent disease.
- Subjects with primary central nervous system (CNS) tumors or clinically active CNS metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Medical Monitor approval.