Assessing the effects of Tuvusertib in patients with advanced solid tumors
Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, Excretion and Absolute Bioavailability of Tuvusertib (M1774) Containing Microtracer 14C Tuvusertib in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)
PHASE1 · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · NCT06308263
This study is testing a new drug called Tuvusertib in people with advanced solid tumors to see how the body processes it and if it can help manage their condition.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT06308263 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the pharmacokinetics and bioavailability of Tuvusertib (M1774) in participants with advanced solid tumors. It consists of two periods: the first focuses on understanding the drug's mass balance and biotransformation pathways, while the second allows participants to receive the drug until disease progression. The study aims to provide insights into the drug's metabolism and clearance mechanisms, which could inform future treatment strategies for solid tumors.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed advanced solid tumors that have not responded to standard therapies or for which no effective standard therapy exists.
Not a fit: Patients with uncontrolled hypertension, severe heart failure, or significant cardiac arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with advanced solid tumors who have limited or no effective therapies available.
How similar studies have performed: Other studies involving ATR inhibitors have shown promise, suggesting that this approach may yield beneficial results, although this specific study's methodology is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 (\<=) 1 * Have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at Screening * Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification more than equal to (\>=) Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc) average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than (\>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start * Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (\<=) Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia) * Treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted) * Participation in a study involving administration of 14C-labeled compound(s) within last 6 months prior to start of study intervention * Other protocol defined exclusion criteria could apply
Where this trial is running
Budapest and 1 other locations
- Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely — Budapest, Hungary (RECRUITING)
- Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály — Budapest, Hungary (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, Ataxia telangiectasia mutated and Rad3-related inhibitor, ADME, Tuvusertib