NCT06315491

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

March 7, 2024

Last Update Submit

October 2, 2025

Conditions

Platinum-resistant Ovarian CancerRefractory Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Randomization to progressive disease (PD) (Up to approximately 21 months)

Secondary Outcomes (11)

  • Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)

    First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months)

  • Median Duration of Response (DoR)

    Date of Initial CR or PR to PD (Up to 21 Months)

  • Progression-Free Survival (PFS)

    Randomization to PD or Date of Death (Up to 21 Months)

  • Plasma levels of CBX-12 (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)

    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

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Drug: CBX-12

Interventions

CBX-12DRUG

CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.

CBX-12 - 100mg/m2 q21dCBX-12 - 125mg/m2 q21d

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Honor Health

Scottsdale, Arizona, 85260, United States

WITHDRAWN

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

ACTIVE NOT RECRUITING

Usc Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

ACTIVE NOT RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

ACTIVE NOT RECRUITING

D&H Cancer Research Center

Margate, Florida, 33063, United States

ACTIVE NOT RECRUITING

South Florida Gynecology

Tampa, Florida, 33606, United States

ACTIVE NOT RECRUITING

Northwest Cancer Centers

Dyer, Indiana, 46311, United States

WITHDRAWN

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

ACTIVE NOT RECRUITING

Women's Cancer Care

Covington, Louisiana, 70433, United States

ACTIVE NOT RECRUITING

Pci Nyu Langone Health

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

Albert Einstein College of Medicine Montefiore Medical

New York, New York, 10021, United States

ACTIVE NOT RECRUITING

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

ACTIVE NOT RECRUITING

Oncology Associates of Oregon

Eugene, Oregon, 97401, United States

ACTIVE NOT RECRUITING

Allegheny Singer Research Institute D/B/A Ahn Research Institution

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

RECRUITING

Texas Oncology- Gulf Coast

The Woodlands, Texas, 77380, United States

ACTIVE NOT RECRUITING

Multicare Institute For Research & Innovation

Tacoma, Washington, 98405, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Michael Needle, MD

    Cybrexa Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Clinical Operations Trial Team

CONTACT

860-717-2731clinicalstudies@cybrexa.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 18, 2024

Study Start

September 25, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations

US(17)