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

Phase 1

Active, not recruiting

• 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

• Registration Number: NCT04902872
• Lead Sponsor: Cybrexa Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-5-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Subject has a histologically- or cytologically-diagnosed solid tumor which is<br> advanced or metastatic and which has progressed on or following at least one<br> systemic therapy regimen administered for advanced or metastatic disease or for<br> which no approved therapy exists. Subject's prior treatment should include all<br> approved regimens that have demonstrated a survival advantage for the subject's<br> disease, stage, and line of therapy.<br><br> - Has measurable disease per RECIST 1.1.<br><br> - An adequate tumor sample must be available from core needle biopsies obtained during<br> the Screening Period and following the subject's most recent systemic therapy.<br><br> - Agrees to an on-treatment biopsy preferably of the same lesion from which the<br> pre-CBX-12 treatment sample was obtained as long as the Investigator determines such<br> biopsy can be performed with acceptable safety. (Removed Amd 4, date 31-Mar-2023)<br><br>Exclusion Criteria:<br><br> - Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy<br> less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be<br> reduced to 2 weeks for bone only radiation therapy or investigational agents not<br> expected to be associated with adverse events (AEs) after 2 weeks of last<br> administration, with Medical Monitor approval.<br><br> - Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days<br> prior to the first dose of CBX-12.<br><br> - Subjects who are currently receiving any other anti cancer or investigational<br> agent(s).<br><br> - Clinically significant intercurrent disease.<br><br> - Subjects with primary central nervous system (CNS) tumors or clinically active CNS<br> metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be<br> enrolled with Medical Monitor approval.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1: Incidence of treatment-emergent adverse events (TEAEs);Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B);Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12 (Schedule C);Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B);Phase 2: Overall response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of CBX-12;Area under the curve from 0-24 hours of CBX-12;Time to maximum concentration of CBX-12;Half-life of CBX-12;Clearance (CL) of CBX-12;Apparent Volume of Distribution at Steady State (Vss) CBX-12;Phase 1: ORR;Duration of Response (DoR);Progression-free Survival (PFS);Phase 2: Incidence of TEAEs