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Ubamatamab

Clinical trials are studying Ubamatamab in adults with recurrent cancers, especially ovarian, fallopian tube, primary peritoneal, endometrial, and other MUC16-positive cancers. These studies are looking at safety, tolerability, dose finding, and early signs of how well treatment works, alone or with other cancer medicines.

Table of Contents

Trial overview

These clinical trials are studying Ubamatamab in adults with cancers that have come back after treatment.[1][2] The main cancer types in the trial data are ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, and other recurrent cancers that express MUC16.[1][2]

Both studies are Phase 1/2 trials, which means they first look at safety and dose, and then look for early signs that the treatment may help.[1][2] Both trials are listed as Authorised and are interventional studies, meaning the research team gives a treatment and follows what happens.[1][2]

Who the trials are for

The trials mainly include adult women with recurrent cancer.[1] One study focuses on women with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.[2] The other study includes adult patients with recurrent ovarian cancer or other recurrent MUC16-positive cancers, which means cancers that show the MUC16 marker.[1]

Because the trial records do not list every entry rule in the source data, the exact participation rules are not shown here.[1][2] In a clinical trial, the study team checks if a person matches the study rules before enrollment.[1][2]

Trial phases and study design

Both studies use a dose escalation part and a dose expansion part.[1][2] Dose escalation means the team studies different dose levels to find a safe and useful dose.[1][2] Dose expansion means more patients are treated at the chosen dose so researchers can learn more about safety and early benefit.[1][2]

NCT03564340 studies Ubamatamab alone and also in combination with cemiplimab.[2] NCT04590326 studies Ubamatamab in combination settings that include REGN5668 and other study arms named in the trial record.[1]

What the trials measure

The main safety measures include dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, deaths, and laboratory abnormalities.[1][2] These are standard trial terms that help show whether a treatment is too hard for the body to handle.[1][2]

The studies also measure pharmacokinetics, which is how the treatment moves through the body over time.[1][2] This helps researchers understand the amount of drug in the blood and how long it stays there.[1][2]

For early benefit, the trials use objective response rate (ORR) based on RECIST 1.1, a standard tumor-measurement system.[1][2] ORR tells researchers how many patients have tumors that shrink in a measurable way.[1][2]

NCT03564340: Ubamatamab alone or with cemiplimab

This study is titled Study of REGN4018 (Ubamatamab) administered alone or in combination with cemiplimab in adult patients with recurrent ovarian cancer or other recurrent MUC16-expressing cancers.[2] The trial includes fallopian tube cancer, endometrial cancer, ovarian cancer, and primary peritoneal cancer in its condition list.[2]

In the dose escalation phase, the study looks at safety, side effects, deaths, lab changes, and drug levels in the blood for Ubamatamab alone and with cemiplimab.[2] The goal is to find the maximum tolerated dose or a recommended phase 2 dose, which are dose levels that help balance safety and study use.[2]

In the dose expansion phase, the study checks early effectiveness by measuring ORR for Ubamatamab alone and with cemiplimab.[2] The trial plans to enroll 689 participants.[2]

NCT04590326: Ubamatamab in combination studies

This study is titled A Study to Find Out How Safe REGN5668 is and How Well It Works in adult women when given with cemiplimab, cemiplimab plus fianlimab, or Ubamatamab.[1] The condition list includes ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.[1]

In the dose escalation phase, the study looks at dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, deaths, lab abnormalities, and serum levels of REGN5668 when it is given alone or with cemiplimab or Ubamatamab.[1] The study also aims to find a maximally tolerated dose or recommended phase 2 dose for the combinations being tested.[1]

In the dose expansion phase, the study measures ORR for REGN5668 in combination with cemiplimab, cemiplimab plus fianlimab, or Ubamatamab, depending on the study cohort.[1] The trial plans to enroll 504 participants.[1]

Key points for patients

Ubamatamab is being studied in people with cancers that have come back, mainly gynecologic cancers such as ovarian, fallopian tube, and primary peritoneal cancer.[1][2] The research is still early, so the main goal is to learn about safety, dose, and early tumor response rather than to prove long-term benefit.[1][2]

These trials are important because they test Ubamatamab in different treatment combinations and in patients with hard-to-treat recurrent cancer.[1][2] The results may help guide later studies if the treatment shows acceptable safety and early signs of activity.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT03564340 Phase 1/2 Recurrent ovarian cancer and other recurrent MUC16-expressing cancers, including fallopian tube, endometrial, ovarian, and primary peritoneal cancer Authorised 689
NCT04590326 Phase 1/2 Ovarian cancer, primary peritoneal cancer, and fallopian tube cancer Authorised 504

FAQ

  • What is being studied in Ubamatamab trials? The trials are studying Ubamatamab as a cancer treatment, either alone or with other medicines such as cemiplimab. Researchers want to learn about safety and whether the treatment can shrink tumors.
  • Who may be able to join these studies? These studies focus on adult women with recurrent ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, or other cancers that express MUC16. Each trial has its own exact rules for who can join.
  • What phases are the Ubamatamab trials in? Both trials are Phase 1/2 studies. Phase 1 usually looks at safety and dose finding, while Phase 2 looks more closely at early signs of benefit.
  • What do the researchers measure in these trials? They measure dose-limiting toxicities, serious side effects, lab changes, and how the drug moves in the body. They also measure objective response rate, which means how many patients have their tumors shrink.
  • Are these trials testing Ubamatamab by itself? One trial studies Ubamatamab alone and with cemiplimab. The other trial studies Ubamatamab as part of combinations, including with REGN5668 and other medicines.

Ongoing Clinical Trials on Ubamatamab

  • Study of ubamatamab alone or with cemiplimab for adults with ovarian, fallopian tube, peritoneal, or endometrial cancer that has come back

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy The Netherlands Spain

  • Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Phase I/II Study of ubamatamab plus drug combination in patients with ovarian cancer who have poor response to first‑line chemotherapy

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Phase 1/2: A study stage that first checks safety and dose, then looks for early signs that the treatment may work.
  • Interventional study: A trial where researchers give a treatment and watch what happens.
  • Dose escalation: A step-by-step process where the study team gives higher doses to find a safe dose.
  • Dose expansion: A later part of a trial where more patients get the chosen dose to learn more about safety and early benefit.
  • Dose-limiting toxicity: A side effect serious enough to stop dose increases or limit how much treatment can be given.
  • Treatment-emergent adverse event: A health problem that starts or gets worse after treatment begins.
  • Serious adverse event: A major side effect that can be life-threatening, cause hospital care, or lead to important health problems.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Objective response rate: The percentage of patients whose tumors shrink or disappear during treatment.
  • RECIST 1.1: A standard way to measure whether tumors get smaller, stay the same, or grow.
  • MUC16-positive: Cancer that has a marker called MUC16 on the tumor cells.
  • Laboratory abnormalities: Unusual blood test results or other lab findings that may show a safety problem.

References