Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05465941

PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Led by Mayo Clinic · Updated on 2026-02-09

43

Participants Needed

1

Research Sites

485 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

CONDITIONS

Official Title

PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
  • Recurrent high-grade serous ovarian cancer initially platinum sensitive with at least one platinum-free interval of 6 months before progression, now platinum resistant
  • No more than one prior line of therapy for platinum resistant disease; prior PARP inhibitor therapy allowed
  • Measurable disease per RECIST 1.1 criteria
  • Disease suitable for two biopsies
  • Life expectancy of at least 12 weeks
  • ECOG performance status of 0, 1, or 2
  • Hemoglobin level of at least 8.0 g/dL within 28 days prior to registration
  • Absolute neutrophil count of at least 1500/mm3 within 28 days prior to registration
  • Platelet count of at least 100,000/mm3 within 28 days prior to registration
  • Total bilirubin at or below 1.5 times the upper limit of normal within 28 days prior to registration
  • ALT and AST levels at or below 3 times the upper limit of normal (or 5 times for patients with liver involvement) within 28 days prior to registration
  • Calculated creatinine clearance of at least 45 ml/min using Cockcroft-Gault formula within 28 days prior to registration
  • Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
  • Provide written informed consent
  • Willing to return to the enrolling institution for follow-up during the active monitoring phase
  • Willing to provide mandatory blood specimens for correlative research
  • Willing to provide mandatory tissue specimens for correlative research
Not Eligible

You will not qualify if you...

  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential unwilling to use adequate contraception
  • Histology other than high-grade serous carcinoma
  • Chemotherapy within 4 weeks prior to registration
  • Immunotherapy within 4 weeks prior to registration
  • Radiotherapy within 4 weeks prior to registration
  • Any other investigational therapy within 4 weeks prior to registration
  • History of prior or concurrent malignancy within 2 years prior to registration, except if it does not interfere with safety or efficacy assessment
  • Uncontrolled intercurrent illness including recent myocardial infarction within 6 months, NYHA class III or IV heart failure, uncontrolled arrhythmias or angina, serious ventricular arrhythmia history, or factors predisposing to arrhythmia
  • Known cardiac disease or prior cardiotoxic treatment unless clinical risk assessment is class IIB or better and QTc ≤ 480 msec for prior doxorubicin recipients
  • Known HIV infection unless on effective therapy with undetectable viral load within 6 months
  • Known hepatitis B or C infection unless viral load is undetectable or patient is cured/on treatment with undetectable viral load
  • Receiving any other investigational agent
  • History of significant gastrointestinal bleeding, colitis, or perforation
  • Severe systemic illness or other severe concurrent disease interfering with safety or assessment
  • Requirement for anticoagulation increasing INR or APTT above normal range except low-dose DVT or line prophylaxis
  • Known central nervous system disease except stable treated brain metastases; active brain metastases or leptomeningeal disease only if immediate treatment not needed
  • Known Gilbert's syndrome or severely reduced UGT1A1 activity alleles
  • Requirement for treatment with UGT1A1 inhibitors during planned PLX038 treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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