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HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST FOLR1 CONJUGATED TO 1-[(2R,3R,4R,5S,52S)-1,2,3,4,5-PENTAHYDROXY-52-{[(2S)-1-{[(2S)-5-CARBAMOYLAMINO-1-OXO-1-{3-[({[(1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12HBENZO[DE]PYRANO[3′,4′:6,7]INDOLIZINO[1,2-B]QUINOLIN-1-YL]CARBAMOYL}OXY)METHYL]ANILINO}PENTAN-2-YL]AMINO}-3-METHYL-1-OXOBUTAN-2-YL]CARBAMOYL}-7-[(2S,3R,4R,5R)-2,3,4,5,6-PENTAHYDROXYHEXYL]-46,54-DIOXO10,13,16,19,22,25,28,31,34,37,40,43-DODECAOXA-7,47,53-TRIAZANONAPENTACONTAN-59-YL]-2,5-DIOXOPYRROLIDIN-3-YL

Clinical trials are studying HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST FOLR1 CONJUGATED TO 1-[(2R,3R,4R,5S,52S)-1,2,3,4,5-PENTAHYDROXY-52-{[(2S)-1-{[(2S)-5-CARBAMOYLAMINO-1-OXO-1-{3-[({[(1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12HBENZO[DE]PYRANO[3′,4′:6,7]INDOLIZINO[1,2-B]QUINOLIN-1-YL]CARBAMOYL}OXY)METHYL]ANILINO}PENTAN-2-YL]AMINO}-3-METHYL-1-OXOBUTAN-2-YL]CARBAMOYL}-7-[(2S,3R,4R,5R)-2,3,4,5,6-PENTAHYDROXYHEXYL]-46,54-DIOXO10,13,16,19,22,25,28,31,34,37,40,43-DODECAOXA-7,47,53-TRIAZANONAPENTACONTAN-59-YL]-2,5-DIOXOPYRROLIDIN-3-YL, also called Rina-S, in several cancers. The trials look at how well it works and, in some studies, how safe it is compared with other treatments.

Table of contents

Overview of the trials

The trial data describe three interventional studies, which means the researchers assign a treatment and then watch what happens.[1] All three studies are authorised and are testing the same named substance, also called Rina-S in the trial titles and summaries.[1][2][3]

The studies focus on different cancer types and use different trial phases, including Phase 2 and Phase 3.[1][2][3] The main purpose is to see how well the treatment works, and in one study to compare treatment safety and efficacy with other options listed by the investigator.[1][2][3]

Platinum-resistant ovarian cancer study

NCT06619236 is a Phase 3 study in platinum-resistant ovarian cancer, which means ovarian cancer that does not respond well to platinum chemotherapy.[1] The study plans to include 532 participants.[1]

This trial compares Rina-S with investigator’s choice of therapy, meaning the study doctor chooses one of the listed standard treatment options for the comparison group.[1] The options listed in the data are pegfilgrastim, paclitaxel, doxorubicin, gemcitabine, and topotecan.[1]

The main endpoint is progression-free survival (PFS), which is the time from randomization until the cancer gets worse or the person dies, whichever happens first.[1] The trial measures this using RECIST v1.1, a standard way to judge changes in solid tumors.[1]

Endometrial cancer study

The study with ID 2024-519818-31-01 is a Phase 3 trial in endometrial cancer, which starts in the lining of the uterus.[2] It includes advanced, recurrent, metastatic, or primary unresectable disease.[2]

This study aims to compare the clinical efficacy of Rina-S with treatment of investigator’s choice in patients whose cancer has come back or gotten worse after prior therapy.[2] The listed comparison drugs are doxorubicin and paclitaxel.[2]

The trial plans to enroll 480 participants.[2] Its primary outcomes are PFS, measured by RECIST v1.1 and reviewed by independent central review, and overall survival (OS), which is the time from study start until death from any cause.[2]

Non-small cell lung cancer study

The study with ID 2025-522107-18-00 is a Phase 2 trial in locally advanced or metastatic non-small cell lung cancer.[3] It plans to enroll 200 participants.[3]

This study is designed to assess the anti-tumor activity of Rina-S as monotherapy, which means it is being studied alone rather than with another cancer drug.[3] The intervention list also includes pegfilgrastim.[3]

The main endpoint is objective response rate (ORR), which is the percentage of patients whose tumors shrink or disappear based on RECIST v1.1 and investigator assessment.[3]

Main study endpoints

Across these trials, the most important outcomes are about tumor control and how long patients live without worsening disease.[1][2][3] The data mention PFS, OS, and ORR as the key endpoints.[1][2][3]

  • PFS asks how long the cancer stays controlled before it grows again.[1][2]

  • OS asks how long patients live after joining the study.[2]

  • ORR asks how many tumors shrink or disappear during treatment.[3]

Who the trials are for

These studies are for adults with specific cancers, not for a general cancer population.[1][2][3] Each trial focuses on a different group: people with platinum-resistant ovarian cancer, people with advanced or recurrent endometrial cancer, and people with locally advanced or metastatic non-small cell lung cancer.[1][2][3]

The endometrial cancer study specifically includes patients with recurrent or progressive disease after prior therapy.[2] The trial data do not give full inclusion or exclusion rules, so only the cancer types and disease settings listed above can be confirmed here.[1][2][3]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT06619236 Phase 3 Platinum-resistant ovarian cancer Authorised 532 Progression-free survival (PFS)
2024-519818-31-01 Phase 3 Endometrial cancer; advanced, recurrent, metastatic, or primary unresectable disease Authorised 480 PFS and overall survival (OS)
2025-522107-18-00 Phase 2 Locally advanced or metastatic non-small cell lung cancer Authorised 200 Objective response rate (ORR)

FAQ

  • What cancers are being studied? The trials study platinum-resistant ovarian cancer, endometrial cancer, and locally advanced or metastatic non-small cell lung cancer.
  • What is the main goal of these trials? The main goals are to measure how well the treatment works and, in some trials, to compare it with the treatment chosen by the investigator. The studies also measure survival and tumor response.
  • Who can take part? People with the specific cancer types listed in each trial may take part. The endometrial cancer trial includes advanced, recurrent, metastatic, or primary unresectable disease.
  • What trial phases are included? The ovarian cancer and endometrial cancer studies are Phase 3 trials. The non-small cell lung cancer study is a Phase 2 trial.
  • What outcomes are being measured? The trials measure progression-free survival, overall survival, and objective response rate. Progression-free survival means the time until the cancer gets worse or the person dies from any cause.

Ongoing Clinical Trials on HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST FOLR1 CONJUGATED TO 1-[(2R,3R,4R,5S,52S)-1,2,3,4,5-PENTAHYDROXY-52-{[(2S)-1-{[(2S)-5-CARBAMOYLAMINO-1-OXO-1-{3-[({[(1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12HBENZO[DE]PYRANO[3′,4′:6,7]INDOLIZINO[1,2-B]QUINOLIN-1-YL]CARBAMOYL}OXY)METHYL]ANILINO}PENTAN-2-YL]AMINO}-3-METHYL-1-OXOBUTAN-2-YL]CARBAMOYL}-7-[(2S,3R,4R,5R)-2,3,4,5,6-PENTAHYDROXYHEXYL]-46,54-DIOXO10,13,16,19,22,25,28,31,34,37,40,43-DODECAOXA-7,47,53-TRIAZANONAPENTACONTAN-59-YL]-2,5-DIOXOPYRROLIDIN-3-YL

  • Phase 2 Study of Rinatabart Sesutecan with PEGFILGRASTIM in Adults with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +2

  • A study comparing Rinatabart Sesutecan to other treatments in patients with endometrial cancer who have previously received platinum-based chemotherapy and PD-L1 therapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Finland France Germany Greece +5

  • Study Comparing Rinatabart Sesutecan with Other Treatments for Patients with Platinum-Resistant Ovarian Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +6

Glossary

  • Platinum-resistant ovarian cancer: Ovarian cancer that no longer responds well to platinum chemotherapy. This type of cancer is often harder to treat.
  • Endometrial cancer: Cancer that starts in the lining of the womb, also called the uterus.
  • Non-small cell lung cancer: The most common type of lung cancer. It can be locally advanced or metastatic.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Locally advanced: Cancer that has grown more than early-stage disease and may be harder to remove or treat.
  • Primary unresectable: Cancer that cannot be removed with surgery at the time it is found.
  • Progression-free survival (PFS): The length of time during and after treatment when the cancer does not get worse.
  • Overall survival (OS): The length of time from treatment start or randomization until death from any cause.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • RECIST v1.1: A standard way doctors measure tumor size changes in cancer trials.
  • Independent central review (BICR): A review of scans or results by experts who are not part of the local study team.
  • Investigator’s choice of therapy: The treatment selected by the study doctor from the options listed in the trial.

References

  1. https://clinicaltrials.eu/trial/study-comparing-rinatabart-sesutecan-with-other-treatments-for-patients-with-platinum-resistant-ovarian-cancer/
  2. https://clinicaltrials.gov/study/2024-519818-31-01
  3. https://clinicaltrials.gov/study/2025-522107-18-00