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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04902872
Other study ID # CBX-12-101
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 3, 2021
Est. completion date September 2024

Study information

Verified date January 2024
Source Cybrexa Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of three 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. Subjects in Phase 1 Modified Part B will be treated with CBX-12 once every 3 weeks. 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 Part B, Part C and Modified Part B, Phase 2 expansion cohorts may open.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
CBX-12
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cybrexa Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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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