Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Rina-S for High Grade Epithelial Ovarian Cancer

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Official registry: https://clinicaltrials.gov/study/NCT05579366 · Genmab · enrollment listed as 952

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rina-S, Carboplatin, or Bevacizumab. The registry lists allocation as randomized. This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

They plan to enroll about 952 people at 67 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

Interventions: Rina-S, Carboplatin, Bevacizumab, Pembrolizumab, Erythromycin, Itraconazole

Primary outcome (registry wording): Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Previously received therapies known to confer clinical benefit
  • Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
  • Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below
  • High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
  • Participants must have platinum-resistant ovarian cancer
  • Participants must have received prior bevacizumab or approved biosimilar
  • Measurable disease per the RECIST v1.1 at baseline

Public study contact (from the registry)

Genmab Trial Information

+4570202728

clinicaltrials@genmab.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

67 listed

+ 30 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Evaluation for NCI Surgery Branch Clinical Research Protocols

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT05579366 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05579366?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05579366?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary