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New treatment option for Ovarian Cancer
Official title Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
ClinicalTrials.gov ID: NCT06930755
What this study is testing
What is NMS-03305293?
NMS-03305293 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube or peritoneal cancer. Sponsor might opt to restrict...
- Patients must have received no more than 5 prior lines of therapy and failed all evidence based local standards of care as per Investigator judgment...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by...
- Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy to National Cancer Institute (NCI) Common Terminology...
You likely can't join if
- Current enrollment in another treatment clinical trial.
- Current treatment with other anticancer agents or devices.
- BReast CAncer gene (BRCA) mutation.
- Prior therapy with PARP inhibitor, outside of approved indication and schedules. Sponsor might opt to restrict prior use of PARP inhibitor (PARPi) in...
- Prior therapy with topoisomerase inhibitors including payloads of Antibody-Drug Conjugates (ADCs). Sponsor has the option to allow prior ADC, if not...
- Major surgery, other than surgery for recurrent Ovarian Cancer (OC), within 4 weeks prior to treatment start.
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube or peritoneal cancer. Sponsor might opt to restrict enrollment to either platinum refractory, primary or secondary...
- Patients must have received no more than 5 prior lines of therapy and failed all evidence based local standards of care as per Investigator judgment. Sponsor might opt to restrict prior lines of therapy to 3 in any...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (radiologically...
- Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) Grade ≤ 1 or to the...
- Patients with childbearing potential must use highly effective contraception or true abstinence.
What rules you out
- Current enrollment in another treatment clinical trial.
- Current treatment with other anticancer agents or devices.
- BReast CAncer gene (BRCA) mutation.
- Prior therapy with PARP inhibitor, outside of approved indication and schedules. Sponsor might opt to restrict prior use of PARP inhibitor (PARPi) in any moments, based on data emerging from the trial.
- Prior therapy with topoisomerase inhibitors including payloads of Antibody-Drug Conjugates (ADCs). Sponsor has the option to allow prior ADC, if not last line of treatment, prior to enrollment.
- Major surgery, other than surgery for recurrent Ovarian Cancer (OC), within 4 weeks prior to treatment start.
- Patients with low-grade/borderline ovarian tumor.
- Prior anti-tumor treatment within 2 weeks prior to treatment start or 5 half-lives, whichever is shorter.
- Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.
- Use of full-dose anticoagulants unless the INR or activated thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of...
- Treatment with concomitant medications known to be sensitive substrates of CYP2D6 and CYP2C19 that cannot be replaced with another treatment.
- History of interstitial lung disease or relevant lung disease in the opinion of the Investigator.
- Treatment with systemic immune modulators such as corticosteroids at prednisone equivalent dose of \> 10 mg/day, cyclosporine and tacrolimus or radiotherapy within 28 days before Cycle 1 Day 1.
- Pregnant women. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of study drug.
- Breast-feeding women or women planning to breast feed during the study or within 3 months after study treatment.
- Known hypersensitivity to any component of NMS-03305293 or topotecan drug formulations.
- Known active, life-threatening or clinically significant uncontrolled systemic infection (bacterial, fungal, viral including Human Immunodeficiency Virus (HIV) positivity or Hepatitis B Virus (HBV) or Hepatitis C Virus...
- Patients with QTc interval ≥ 450 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT...
- Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes or structural issues or ulcer that would...
- Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic...
- History of long QT disorder or familial sudden death syndromes or related syndromes in the opinion of the Investigator.
- Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or cone biopsied or post curative intention in situ carcinoma of the cervix uteri and/or superficial bladder...
- Symptomatic, or untreated Central Nervous System (CNS) lesions except stable and well-controlled with no neurological symptoms; patients receiving corticosteroids to control neurological symptoms should be on stable...
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Illinois, United States
- St Louis, Missouri, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Illinois, United States; St Louis, Missouri, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.