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