Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
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.
Checked against the public recordLast updated Aug 20, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Cybrexa Therapeutics
- Interventions being studied
- Drug: CBX-12
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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. (Removed Amd 4, date 31-Mar-2023) Exclusion Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale Cancer CenterNew Haven, Connecticut
- NEXT OncologyAustin, Texas
- MD Anderson Cancer CenterHouston, Texas
- NEXT OncologySan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 20, 2026. Always confirm current availability with the study team.