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Trial Title:
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
NCT ID:
NCT06315491
Condition:
Platinum-resistant Ovarian Cancer
Refractory Ovarian Carcinoma
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CBX-12
Description:
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active
moiety.
Arm group label:
CBX-12 - 100mg/m2 q21d
Arm group label:
CBX-12 - 125mg/m2 q21d
Summary:
The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12
in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125
mg/m2 every 21 days or 100 mg/m2 every 21 days.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects must have histologically- or cytologically-diagnosed epithelial high-grade
serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that
is refractory to prior therapy and must have platinum-resistant disease defined as:
- Subjects who have received only 1 platinum-based chemotherapy regimen for at
least 4 cycles of platinum must have disease progression on treatment or
occurring ≤ 26 weeks after their last dose of platinum.
- Patients who have progressed following a second course of a platinum based
regimen.
- Subjects may have up to 2 additional systemic regimens for advanced or
metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or
bevacizumab) are not considered separate regimens.
- Age greater than or equal to 18 years at the time of signing the informed consent
form (ICF).
- Has measurable disease per RECIST 1.1.
- Has provided written informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate liver, renal, hematologic, pulmonary and coagulation function.
Exclusion Criteria:
- Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy
within 3 weeks prior to the first dose of CBX-12.
- Subjects who are currently receiving any other anticancer or investigational
agent(s).
- Clinically significant intercurrent disease.
- Active human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C infection.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
D&H Cancer Research Center
Address:
City:
Margate
Zip:
33063
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Chacin
Phone:
954-323-2422
Facility:
Name:
Women's Cancer Care
Address:
City:
Covington
Zip:
70433
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Aldana
Phone:
504-892-2252
Start date:
August 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Cybrexa Therapeutics
Agency class:
Industry
Source:
Cybrexa Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06315491
