Actively Recruiting
Phase II Clinical Trial of PLX038 for 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
254 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
Researchers are evaluating the investigational drug pegylated SN-38 conjugate PLX038 in patients with metastatic platinum-resistant ovarian, primary peritoneal, and fallopian tube cancers. This phase II trial aims to determine whether PLX038 can shrink tumors in these patients by blocking enzymes necessary for tumor cell growth. The study also explores survival outcomes, tolerability, and various biological markers related to treatment response. Participants receive PLX038 intravenously over one hour on the first day of each 21-day treatment cycle. Treatment continues in the absence of disease progression or unacceptable side effects. Throughout the study, patients undergo CT scans, tumor biopsies, and blood and stool sample collections during screening and treatment to monitor effects and research biomarkers. After treatment ends, participants are followed up 30 days later and then every six months for up to five years. During the trial, researchers assess tumor response rates using standardized criteria and track progression-free and overall survival. Safety is monitored up to 30 days post-treatment, and multiple laboratory tests and biopsies help evaluate drug activity and side effects. Participants must be available for regular follow-up visits during the active monitoring phase, contributing samples and undergoing imaging to support comprehensive study assessments.
CONDITIONS
Brief Title
PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
- Recurrent platinum-resistant high grade serous ovarian cancer with prior platinum sensitivity
- No more than one prior line of therapy for platinum-resistant disease
- Measurable disease by 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 8.0 g/dL or higher
- Absolute neutrophil count 1500/mm³ or higher
- Platelet count 100,000/mm³ or higher
- Total bilirubin 1.5 times upper limit of normal or less
- ALT and AST levels 3 times upper limit of normal or less (5 times for liver involvement)
- Creatinine clearance 45 ml/min or higher
- Negative pregnancy test for persons of childbearing potential
- Written informed consent provided
- Willing to return for follow-up visits during active monitoring
- Willing to provide mandatory blood and tissue specimens for research
You will not qualify if you...
- Pregnant or nursing persons, or those unwilling to use adequate contraception due to genotoxic risks
- Histology other than high grade serous carcinoma
- Chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 4 weeks prior to registration
- History of other malignancy within 2 years unless unlikely to interfere with study
- Uncontrolled illness such as recent myocardial infarction, severe heart failure, uncontrolled arrhythmias, or serious ventricular arrhythmias
- Known cardiac disease or prior cardiotoxic treatment unless meeting specific cardiac function criteria
- Known HIV infection unless on effective therapy with undetectable viral load
- Known hepatitis B or C infection unless controlled or cured with undetectable viral load
- Receiving any other investigational agent
- History of significant gastrointestinal bleeding, colitis, or perforation
- Severe co-morbid illnesses interfering with safety or assessment
- Requirement for anticoagulation that raises INR or APTT above normal except low dose prophylaxis
- Known central nervous system disease except treated brain metastases without progression
- Known Gilbert's syndrome or severely reduced UGT1A1 enzyme activity
- Need for treatment with UGT1A1 inhibitors during study treatment period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including CT, biopsy, and blood and stool sample collection
Duration - Up to 6 cycles of 21 days each
Participants receive PLX038 intravenously over 1 hour on day 1 of each 21-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, biopsy, and blood and stool sample collection during treatment.
1 visit every 21 days per cycle for infusion and assessments
Duration - 30 days and then every 6 months for up to 5 years
After completing study treatment, participants are followed up to monitor health outcomes and safety.
1 visit at 30 days post-treatment and visits every 6 months thereafter
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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