161 Participants Needed

M1774 + Niraparib for Solid Tumors

Recruiting at 18 trial locations
CC
UM
Overseen ByUS Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: EMD Serono Research & Development Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib.

Do I need to stop my current medications to join the trial?

The trial protocol mentions 'prohibited concomitant medication,' but it does not specify which medications are prohibited. It's best to discuss your current medications with the trial team to see if any need to be stopped.

What safety information is available for the treatment M1774 + Niraparib for solid tumors?

Niraparib, also known as Zejula, has been studied for safety in various cancers. It has a manageable safety profile, with the main concern being myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). Other possible side effects include neuropathy (nerve damage), photosensitivity (sensitivity to light), and gastroesophageal reflux disease (acid reflux).12345

What makes the drug combination of M1774 and Niraparib unique for treating solid tumors?

The combination of M1774 and Niraparib is unique because Niraparib is a PARP inhibitor that helps repair DNA damage in cancer cells, and it is used in combination with other drugs to enhance its effectiveness. This combination is being explored for its potential to treat solid tumors, which may not have standard treatment options.12367

Who Is on the Research Team?

MR

Medical Responsible

Principal Investigator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that haven't responded to standard treatments or have no suitable standard options. They should be relatively healthy (ECOG <=1), possibly with treated, symptom-free brain metastases. Specific genetic mutations are required for some parts of the study, and participants must not be pregnant or breastfeeding.

Inclusion Criteria

My blood, liver, and kidney functions meet the required levels.
My cancer has specific genetic mutations in ARID1A, ATRX, DAXX, or ATM.
I am not pregnant or breastfeeding.
See 9 more

Exclusion Criteria

Participants with active and/or uncontrolled infection with exceptions
I haven't had a heart attack, severe chest pain, heart failure, or heart surgery in the last 6 months.
Uncontrolled arterial hypertension (systolic blood pressure >140 mmHg; Diastolic blood pressure >90mmHg)
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tuvusertib (M1774) as monotherapy or in combination with Niraparib, with dose escalation and confirmation phases

Variable, based on dose escalation and confirmation phases

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after the last dose, assessed up to approximately 2.2 years

What Are the Treatments Tested in This Trial?

Interventions

  • M1774
  • Niraparib
Trial Overview The trial tests M1774 alone and combined with Niraparib, a PARP inhibitor, in people with certain solid tumors. It's an early-phase study to determine safety, tolerability, how the body processes the drugs (with/without food), and any preliminary signs of effectiveness.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Part B1: Combination Therapy Dose FindingExperimental Treatment2 Interventions
Group II: Part A5: China Dose Confirmation MonotherapyExperimental Treatment1 Intervention
Group III: Part A4: Japan Dose Confirmation MonotherapyExperimental Treatment1 Intervention
Group IV: Part A3 - Monotherapy ExpansionExperimental Treatment1 Intervention
Group V: Part A2 - Preliminary Food Effect AssessmentExperimental Treatment1 Intervention
Group VI: Part A1: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials
86
Recruited
22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials
449
Recruited
122,000+
Danny Bar-Zohar profile image

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo profile image

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

Published Research Related to This Trial

Niraparib, a recently approved treatment for recurrent platinum-sensitive ovarian cancer, has demonstrated a high oral bioavailability of 72.7% in humans, indicating effective absorption when taken orally.
The study involved six patients who received a therapeutic dose of 300 mg of niraparib, followed by a small intravenous dose to measure its levels in the bloodstream, confirming its potential as a convenient oral treatment option.
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients.van Andel, L., Rosing, H., Zhang, Z., et al.[2019]
Niraparib has been approved by the FDA for patients with complete or partial response to first-line platinum-based chemotherapy, regardless of their BRCAm or HRD status, expanding treatment options for more patients.
Olaparib, in combination with bevacizumab, has also received FDA approval for patients with epithelial ovarian cancer, indicating that PARP inhibitors are now beneficial not only for BRCAm and HRD-deficient patients but also for those with HRD-proficient tumors.
PARP inhibitors in the treatment of ovarian cancer: a review.Washington, CR., Moore, KN.[2023]
Niraparib at a dose of 200 mg/day was determined to be the recommended phase 2 dose when combined with abiraterone acetate plus prednisone (AAP) for patients with metastatic castration-resistant prostate cancer (mCRPC), as it showed a tolerable safety profile with no new safety signals.
The combination of niraparib with apalutamide resulted in a higher incidence of dose-limiting toxicities, leading to the decision not to further evaluate this combination, highlighting the importance of monitoring drug interactions in treatment regimens.
Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE).Saad, F., Chi, KN., Shore, ND., et al.[2021]

Citations

Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
PARP inhibitors in the treatment of ovarian cancer: a review. [2023]
Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). [2021]
Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. [2022]
A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib. [2023]
Niraparib with Abiraterone Acetate and Prednisone for Metastatic Castration-Resistant Prostate Cancer: Phase II QUEST Study Results. [2023]
The safety, tolerability and pharmacokinetics of niraparib in Japanese patients with solid tumours: results of a phase I dose-escalation study. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security