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
Brief 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
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 (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.
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 both Part B and Part C,
Phase 2 expansion cohorts may open.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Secondary Outcome
Maximum concentration of CBX-12
Condition
Solid Tumor, Adult
Intervention
CBX-12
Study Arms / Comparison Groups
Phase 1 Dose Escalation (Daily Dosing x 3)
Description: CBX-12 administered on a daily x 3, 3 week schedule
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
112
Start Date
May 3, 2021
Completion Date
April 2024
Primary Completion Date
January 2024
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Chief Medical Officer, 860-501-3027, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04902872
Organization ID
CBX-12-101
Responsible Party
Sponsor
Study Sponsor
Cybrexa Therapeutics
Study Sponsor
Chief Medical Officer, Study Director, Cybrexa Therapeutics
Verification Date
May 2022