Clinical trial · Interventional
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
NCT06315491CI-TRIAL-00123003terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Limited clinical activity
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
| Refractory Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBX-12 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBX-12 - 125mg/m2 q21d
- description
- 125mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.
- interventionNames
- Drug: CBX-12
- type
- EXPERIMENTAL
- label
- CBX-12 - 100mg/m2 q21d
- description
- 100mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.
- interventionNames
- Drug: CBX-12
Primary outcomes (1)
- measure
- Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.