Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Verified date | January 2024 |
Source | Cybrexa Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | September 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NEXT Oncology | Austin | Texas |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | NEXT Oncology | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Cybrexa Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Incidence of treatment-emergent adverse events (TEAEs) | NCI CTCAE v5.0 | Through the end of study, estimated as 6 months | |
Primary | Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B) | Safety Review Committee Analysis of Safety and PK Data | 15 months | |
Primary | Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12 (Schedule C) | Safety Review Committee Analysis of Safety and PK Data | 15 months | |
Primary | Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B) | Safety Review Committee Analysis of Safety and PK Data | 15 months | |
Primary | Phase 2: Overall response rate (ORR) | ORR Based on RECIST v1.1 | Through the end of study, estimated as 6 months | |
Secondary | Maximum concentration of CBX-12 | PK Analysis | 5 days | |
Secondary | Area under the curve from 0-24 hours of CBX-12 | PK Analysis | 5 days | |
Secondary | Time to maximum concentration of CBX-12 | PK Analysis | 5 days | |
Secondary | Half-life of CBX-12 | PK Analysis | 5 days | |
Secondary | Clearance (CL) of CBX-12 | PK Analysis | 5 days | |
Secondary | Apparent Volume of Distribution at Steady State (Vss) CBX-12 | PK Analysis | 5 days | |
Secondary | Phase 1: ORR | Based on RECIST v1.1 | Through the end of study, estimated as 6 months | |
Secondary | Duration of Response (DoR) | Based on RECIST v1.1 | Through the end of study, estimated as 6 months | |
Secondary | Progression-free Survival (PFS) | Based on RECIST v1.1 | Through the end of study, estimated as 6 months | |
Secondary | Phase 2: Incidence of TEAEs | NCI CTCAE v5.0 | Through the end of study, estimated as 6 months |
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