Actively Recruiting
Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
Led by Nerviano Medical Sciences · Updated on 2026-03-31
24
Participants Needed
5
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label Phase Ia/b study on the safety and efficacy of the combination of NMS-03305293 and topotecan in patients with recurrent ovarian cancer, with dose-limiting toxicity (DLT) escalation. The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with topotecan.
CONDITIONS
Official Title
Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube, or peritoneal cancer
- No more than 5 prior lines of therapy received and failure of all evidence-based local standards of care
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Radiographic progression after most recent anticancer therapy and measurable disease by RECIST v1.1
- Resolution of acute toxic effects from prior therapy to NCI CTCAE Grade 1 or baseline laboratory values
- Patients with childbearing potential must use highly effective contraception or true abstinence
You will not qualify if you...
- Current enrollment in another interventional clinical trial
- Current treatment with other anticancer agents or devices
- Presence of BRCA mutation or homologous recombination deficiency
- Prior therapy with PARP inhibitors outside approved indications
- Prior therapy with topoisomerase inhibitors including ADC payloads
- Major surgery (except recurrent ovarian cancer surgery) within 4 weeks before treatment
- Low-grade or borderline ovarian tumor
- Anti-tumor treatment within 2 weeks or 5 half-lives before treatment start
- Prior wide-field radiotherapy affecting at least 20% of bone marrow
- Use of full-dose anticoagulants without stable dose or therapeutic INR/aPTT
- Treatment with CYP2D6 or CYP2C19 sensitive substrate medications that cannot be replaced
- History of interstitial lung disease or relevant lung disease
- Use of systemic immune modulators above prednisone 10 mg/day or recent radiotherapy within 28 days
- Pregnant or breastfeeding women
- Known hypersensitivity to study drugs
- Known active, life-threatening, or uncontrolled systemic infections requiring treatment
- QTc interval ≥ 450 ms or risk factors for torsade de pointes
- Known active gastrointestinal disease or malabsorption impacting drug absorption
- Major cardiovascular or thromboembolic events within last 6 months
- History of long QT disorder or familial sudden death syndromes
- Active second malignancy except certain treated skin, cervical, or bladder cancers
- Symptomatic or untreated CNS lesions except stable and well-controlled
- Other severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study participation or results interpretation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
2
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
3
Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Domenico Roberti
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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