Description: 
            
            
              
                
      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.
    
              
             
           
        
      
        
          
      
        
          
Title
- Brief Title: Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
- Official Title: A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
                CBX-12-101
- NCT ID:
                NCT04902872
Conditions
- Solid Tumor, Adult
- Epithelial Ovarian Cancer
- Small Cell Lung Carcinoma
Interventions
| Drug | Synonyms | Arms | 
|---|
| CBX-12 |  | Phase 1 Dose Escalation (Daily Dosing x 3) | 
Purpose
      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
      two 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. Subjects in Phase 1 Part B will be treated with
      CBX-12 on a daily x 3 every 3 weeks schedule. Once at least 2 cohorts in Part A have been
      evaluated for safety through the dose-limiting toxicity (DLT) period and the Safety Review
      Committee (SRC) has reviewed the safety and available PK data for the completed Part A
      cohorts, the first cohort in Part B may open for accrual. The initial dose in Part B will be
      determined based on the safety and tolerability of Part A subjects to that point.
      Once the recommended phase 2 dose (RP2D) has been established in both Part A and Part B,
      Phase 2 expansion cohorts may open.
    Trial Arms
| Name | Type | Description | Interventions | 
|---|
| Phase 1 Dose Escalation (Daily Dosing x 5) | Experimental | CBX-12 administered on a daily x 5 every 3 weeks schedule |  | 
| Phase 1 Dose Escalation (Daily Dosing x 3) | Experimental | CBX-12 administered on a daily x 5 every 3 weeks schedule |  | 
| Phase 2 Ovarian Cancer Expansion Cohort | Experimental | CBX-12 administered on a daily x 5 every 3 weeks or on a daily x 3 every 3 weeks schedule |  | 
| Phase 2 Small Cell Lung Cancer Expansion Cohort | Experimental | CBX-12 administered on a daily x 5 every 3 weeks or on a daily x 3 every 3 weeks schedule |  | 
Eligibility Criteria
        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.
        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.
      | Maximum Eligible Age: | N/A | 
| Minimum Eligible Age: | 18 Years | 
| Eligible Gender: | All | 
| Healthy Volunteers: | No | 
Primary Outcome Measures
| Measure: | Phase 1: Incidence of treatment-emergent adverse events (TEAEs) | 
| Time Frame: | Through the end of study, estimated as 6 months | 
| Safety Issue: |  | 
| Description: | Based on RECIST v1.1 | 
Secondary Outcome Measures
| Measure: | Maximum concentration of CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Area under the curve from 0-24 hours of CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Time to maximum concentration of CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Half-life of CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Clearance (CL) of CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Apparent Volume of Distribution at Steady State (Vss) CBX-12 | 
| Time Frame: | 5 days | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Phase 1: ORR | 
| Time Frame: | Through the end of study, estimated as 6 months | 
| Safety Issue: |  | 
| Description: | Based on RECIST v1.1 | 
| Measure: | Duration of Response (DoR) | 
| Time Frame: | Through the end of study, estimated as 6 months | 
| Safety Issue: |  | 
| Description: | Based on RECIST v1.1 | 
| Measure: | Progression-free Survival (PFS) | 
| Time Frame: | Through the end of study, estimated as 6 months | 
| Safety Issue: |  | 
| Description: | Based on RECIST v1.1 | 
| Measure: | Phase 2: Incidence of TEAEs | 
| Time Frame: | Through the end of study, estimated as 6 months | 
| Safety Issue: |  | 
| Description: |  | 
Details
| Phase: | Phase 1/Phase 2 | 
| Primary Purpose: | Interventional | 
| Overall Status: | Recruiting | 
| Lead Sponsor: | Cybrexa Therapeutics | 
Trial Keywords
- SCLC
- small cell lung cancer
- ovarian
Last Updated
May 28, 2021