A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

March 14, 2024 updated by: Cybrexa Therapeutics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBX-12 - 125mg/m2 q21d
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.
Drug: CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
Experimental: CBX-12 - 100mg/m2 q21d
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.
Drug: CBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization to progressive disease (PD) (Up to approximately 21 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Safety as assessed by the incidence of treatment-emergent AEs (TEAEs).
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)
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.
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)
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.
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
Assessment of pharmacokinetic (PK) variable AUC0-24hr
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
Assessment of pharmacokinetic (PK) variable Cmax
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
Assessment of pharmacokinetic (PK) variable Tmax
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
Assessment of pharmacokinetic (PK) variable T1/2
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
Assessment of pharmacokinetic (PK) variable AUC0-24hr
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
Assessment of pharmacokinetic (PK) variable Cmax
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
Assessment of pharmacokinetic (PK) variable Tmax
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
Assessment of pharmacokinetic (PK) variable T1/2
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cybrexa Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBX-12-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Platinum-resistant Ovarian Cancer

Clinical Trials on CBX-12

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe