Platinum-resistant Ovarian CancerPhase 2NCT06315491
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
A Phase 2 study testing CBX-12 in people with Platinum-resistant Ovarian Cancer and Refractory Ovarian Carcinoma, run by Cybrexa Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Ovarian Cancer, Refractory Ovarian Carcinoma
- What is being tested?
- CBX-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Has provided written informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate liver, renal, hematologic, pulmonary and coagulation function.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
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.
- Being tested
- CBX-12
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBX-12Drug
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
| Study group | Role | What they receive |
|---|---|---|
| CBX-12 - 125mg/m2 q21d | Experimental | 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. Receives: Drug: CBX-12 |
| CBX-12 - 100mg/m2 q21d | Experimental | 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. Receives: Drug: CBX-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
ORR is defined as the proportion of subjects achieving a confirmed best overall response (BOR) of CR or PR defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Measured: Randomization to progressive disease (PD) (Up to approximately 21 months)
Secondary outcomes (11)
Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)
Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).
Measured: First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)
Median Duration of Response (DoR)
Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.1 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause.
Measured: Date of Initial CR or PR to PD (Up to 21 Months)
Progression-Free Survival (PFS)
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST (RECIST v1.1) criteria or death from any cause.
Measured: Randomization to PD or Date of Death (Up to 21 Months)
Plasma levels of CBX-12 (AUC0-24hr)
Assessment of pharmacokinetic (PK) variable AUC0-24hr
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (Cmax)
Assessment of pharmacokinetic (PK) variable Cmax
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (Tmax)
Assessment of pharmacokinetic (PK) variable Tmax
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (T1/2)
Assessment of pharmacokinetic (PK) variable T1/2
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (AUC0-24hr)
Assessment of pharmacokinetic (PK) variable AUC0-24hr
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (Cmax)
Assessment of pharmacokinetic (PK) variable Cmax
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (Tmax)
Assessment of pharmacokinetic (PK) variable Tmax
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (T1/2)
Assessment of pharmacokinetic (PK) variable T1/2
Measured: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start25 Sep 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Why it stopped: Limited clinical activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cybrexa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Needle, MD, Study director, Cybrexa Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315491
- Sponsor's protocol ID
- CBX-12-201
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06315491
- Acronym / sponsor ID
- CBX-12-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited clinical activity
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cybrexa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBX-12 - 125mg/m2 q21d | Experimental | Drug: CBX-12125mg/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. |
| CBX-12 - 100mg/m2 q21d | Experimental | Drug: CBX-12100mg/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBX-12CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety. | Drug | CBX-12 - 100mg/m2 q21d, CBX-12 - 125mg/m2 q21d |
Primary outcome
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time frame: Randomization to progressive disease (PD) (Up to approximately 21 months)
ORR is defined as the proportion of subjects achieving a confirmed best overall response (BOR) of CR or PR defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
11 secondary outcomes
Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)
Median Duration of Response (DoR)
Time frame: Date of Initial CR or PR to PD (Up to 21 Months)
Progression-Free Survival (PFS)
Time frame: Randomization to PD or Date of Death (Up to 21 Months)
Plasma levels of CBX-12 (AUC0-24hr)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (Cmax)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (Tmax)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of CBX-12 (T1/2)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (AUC0-24hr)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (Cmax)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (Tmax)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Plasma levels of Exatecan (T1/2)
Time frame: At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose
Results and safety
The study was stopped early (reason given: Limited clinical activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Needle, MD study director
Cybrexa Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBX-12 in people with Platinum-resistant Ovarian Cancer and Refractory Ovarian Carcinoma, run by Cybrexa Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Limited clinical activity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] (time frame: Randomization to progressive disease (PD) (Up to approximately 21 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.