NCT04902872

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

A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Cybrexa Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 tumors.

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 daily x 5 every 3 weeks schedule (treatment in Part A was discontinued in October 2021). Subjects in Phase 1 Part B will be treated with CBX-12 on a daily x 3 every 3 weeks schedule. Subjects in Phase 1 Part C will be treated with CBX-12 once weekly. Subjects in Phase 1 Modified Part B will be treated with CBX-12 once every 3 weeks. For all parts in Phase 1, after all subjects in a cohort have completed treatment through the DLT period or discontinued treatment due to a DLT, the SRC, composed of the Investigators who have enrolled subjects in the current cohort(s), the study Medical Monitor and ad hoc members (e.g., other Investigators, a statistician) as needed, will review all available safety data, including DLTs and all available PK data for that cohort and make dose-level recommendations. Once the recommended phase 2 dose (RP2D) has been established in Part B, Part C and Modified Part B, Phase 2 expansion cohorts may open.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	CBX-12	CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety

Timeline

• Start date: 2021-05-03
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2021-05-26
• Last updated: 2025-01-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study