Status:
ACTIVE_NOT_RECRUITING
Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Lead Sponsor:
Cybrexa Therapeutics
Conditions:
Solid Tumor, Adult
Epithelial Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 tumo...
Detailed Description
Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of three dosing schedules of CBX-12 will be evaluated. Subjects in Part A will be treated with CBX-12 on a dail...
Eligibility Criteria
Inclusion
- Key
- 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. (Removed Amd 4, date 31-Mar-2023)
Exclusion
- 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.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04902872
Start Date
May 3 2021
End Date
June 1 2025
Last Update
January 23 2025
Active Locations (4)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06511
2
NEXT Oncology
Austin, Texas, United States, 78758
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
NEXT Oncology
San Antonio, Texas, United States, 78229