Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Epithelial Ovarian Cancer, Small Cell Lung Carcinoma, Breast Cancer, Colorectal Cancer, Pancreas Cancer, Appendix Cancer, Non-small Cell Lung Cancer, Gastric Cancer, Esophagus Cancer, Urothelial Carcinoma, Sarcoma

In brief

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.

Key facts

Study ID

NCT04902872

Run by

Cybrexa Therapeutics

People needed

69

Starts

2021-05-03

Expected to finish

2025-06-24

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• NEXT Oncology — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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