Health Trials

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

ConditionsHigh Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerEndometrial CancerNon-small Cell Lung CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)MesotheliomaBreast AdenocarcinomaTriple Negative Breast CancerHormone Receptor-positive/Her2 Negative Breast CancerPlatinum-resistant Ovarian Cancer (PROC)Platinum Sensitive Ovarian Cancer (PSOC)Primary Refractory Ovarian CancerUterine Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenmab

About this trial

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).

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).

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.

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)

Disqualifiers

History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Trial design

Treatments tested in this trial

  • Rina-S
  • Carboplatin
  • Bevacizumab
  • Pembrolizumab

Treatment groups

884 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Genmab

Lead sponsor

Source ClinicalTrials.gov