Breast Cancer Clinical Trial

Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT04902872

Recruitment Status:

Recruiting

Sponsor:

Cybrexa Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

Yale Cancer Center
New Haven Connecticut, 06511, United States More Info
Ingrid Palma
Contact
203-833-1034
[email protected]
Joseph Paul Eder, MD
Principal Investigator
NEXT Oncology
Austin Texas, 78758, United States More Info
Glenda Chambers
Contact
210-580-9520
[email protected]
Nicole Klein
Contact
737-618-5210
[email protected]
Andrae L Vandross, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Krystle Luna
Contact
713-302-9904
[email protected]
Funda Meric-Bernstam, MD
Principal Investigator
NEXT Oncology
San Antonio Texas, 78229, United States More Info
Cynthia De Leon
Contact
210-580-9521
[email protected]
Anthony Tolcher, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT04902872

Recruitment Status:

Recruiting

Sponsor:


Cybrexa Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.