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New drug tested to protect fertility in women with rare tumors

NCT ID NCT07176689

Disease control Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This study tests the drug nirogacestat in 50 premenopausal women with desmoid tumors (a type of non-cancerous but aggressive growth). The main goal is to see if the drug affects ovarian function, such as menstrual periods and hormone levels. Participants take nirogacestat orally, and researchers monitor for any temporary or lasting changes in fertility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nirogacestat (oral tablet)
What this could lead to
If successful, this study could show that nirogacestat is safe for ovarian function, allowing younger women with desmoid tumors to preserve fertility while controlling their disease.
What could go wrong
This is a small, early-phase study with no placebo group, so results may not apply broadly. The drug may still cause ovarian toxicity or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant is female, postpubertal aged ≥18 and ≤40 years of age at the time of signing the informed consent and premenopausal at baseline. Premenopausal is defined as meeting all of the following: Estradiol \>30 pg/mL. Follicle-stimulating hormone (FSH) \<40 IU/L. Regular menses (e.g., menstrual cycle length of 21 to 35 days) for at least 3 menstrual cycles prior to signing informed consent * Participant uses 1 highly effective non-hormonal contraceptive method, has a negative pregnancy test prior to first dose of study treatment), is not breastfeeding, agrees to not harvest or donate eggs for at least 90 days prior to and during the study * Participant has histologically confirmed DT/AF with symptomatic or progressive disease requiring systemic treatment * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at screening * Participant has adequate organ and bone marrow function. Exclusion Criteria: * Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat * Participant has experienced any of the following within 6 months of signing informed consent: clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. * Participant has had lymphoma, leukemia, or any malignancy within the past 5 years at the time of informed consent, except for any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast), with no evidence of metastatic disease for 3 years at the time of informed consent. * Participant has known hepatic impairment * Participant previously received or is currently receiving gamma secretase inhibitors or anti-Notch antibody therapy * Participant is currently using any treatment for DT/AF including tyrosine kinase inhibitors (TKIs) or any investigational treatment 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment * Participant is currently using or anticipates using food or drugs that are known strong/moderate cytochrome P450 (CYP) 3A4 inhibitors, or strong CYP3A inducers within 14 days prior to the first dose of study treatment. * Participant has a history of polycystic ovary syndrome, hypothalamic amenorrhea, severe endometriosis involving ovaries, family history of primary ovarian insufficiency, any chromosomal abnormality, mutation, gene variant or medical condition associated with early/premature menopause, including a history of OT while on a TKI * Participant is currently using or has used hormonal contraception or ovarian suppression within 90 days prior to first dose of study treatment * Participant has a history of heavy tobacco smoking (≥20 pack years) or is a current smoker (\>1 pack per day) * Participant has experienced other severe acute or chronic medical or psychiatric conditions within 1 year of signing informed consent. * Participant is unable to comply with study related procedures (including, but not limited to, the completion of a menstrual diary and electronic patient-reported outcomes and ability to return to clinic for hormone level blood draws timed to the menstrual cycle (days 1-5)

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Conditions

The condition(s) this trial relates to.

desmoid tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aggressive fibromatosis Desmoid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Academisch Ziekenhuis Leiden

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Cambridge University - Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Cliniques Universitaires Saint-Luc (CUSL)

    RECRUITING

    Brussels, 1200, Belgium

  • Fondazione IRCCS Istituto Nazionale dei Tumori Milano

    RECRUITING

    Milan, 20133, Italy

  • Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS Istituto Ortopedico Rizzoli di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

    RECRUITING

    Meldola, Forli-Cesena, 47014, Italy

  • Institut Catala d'Oncologia

    RECRUITING

    Barcelona, 08907, Spain

  • Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • La Fondazione e l'Istituto di Candiolo

    RECRUITING

    Candiolo, Torino, 10060, Italy

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, 00128, Italy

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Universitaetsmedizin Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • University College London Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

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