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NCT05396833 · ClinicalTrials.gov registry record · Phase 1
Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)
A Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors, sponsored by EMD Serono Research & Development Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05396833 is a Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors that is active but no longer recruiting, run by EMD Serono Research & Development Institute. The registered enrollment target is 120 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT05396833, a Phase 1 study of Metastatic or Locally Advanced Unresectable Solid Tumors, is active but no longer recruiting, sponsored by EMD Serono Research & Development Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for tuvusertib in combination with lartesertib (in Part A1), food effect on the PK of lartesertib as monotherapy followed by treatment with tuvusertib in combination with lartesertib in participants with specific tumor types (in Part A1.1), relative bioavailability of a tuvusertib tablet formulation vs capsule formulation followed by treatment with tuvusertib (capsule) in combination with lartesertib in participants with specific tumor types (in Part A1.2), safety/tolerability and early signs of clinical activity of tuvusertib (capsule)and lartesertib in combination in participants with prostate cancer harboring loss of function (LoS) mutation in the gene ATM based on historic data collected prior to prescreening in circulating tumor (ct) DNA (liquid biopsies) or tumor biopsies (in Part A2), safety/tolerability and early signs of clinical activity of tuvusertib and lartesertib in combination in participants with endometrial cancer harboring LoS mutation(s) in the gene ARID1A based on historic data collected prior to prescreening in ctDNA (liquid biopsies) or tumor biopsies (in Part A3), the relative bioavailability of a tuvusertib tablet formulation (TF1, test) compared to a capsule formulation (reference) will also be investigated (in Part A2/A3), and identify a potential set of MTD combinations, and establish the RDE for the combination of tuvusertib and avelumab in participants with metastatic or locally advanced unresectable solid tumors (in Part B1).
Conditions Studied
Interventions
- DRUG Avelumab
- DRUG Tuvusertib
- DRUG Lartesertib
Study Locations (20)
Other
- Royal North Shore Hospital - St Leonards
- Calvary Mater Newcastle - PARENT - Waratah
- Princess Margaret Cancer Centre - Toronto
- Seoul National University Bundang Hospital - Seongnam-si
- Severance Hospital, Yonsei University Health System - Division of Infectious Diseases - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- The Catholic University of Korea, Seoul St. Mary's Hospital - Seoul
- Korea University Guro Hospital - Seoul
- Hospital QuironSalud Barcelona - Next Oncology - Barcelona
- Hospital Clinic de Barcelona - Servicio de Oncologia - Barcelona
- Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica - Madrid
Texas
- Mary Crowley Cancer Research Centers - Dallas
- University of Texas M. D. Anderson Cancer Center - Partner - Houston
- NEXT Oncology - San Antonio
California
- Providence Medical Foundation - Santa Rosa
Florida
- University of Miami School of Medicine - Miami
Georgia
- Augusta University - formerly Georgia Regents University - Augusta
Kansas
- The University of Kansas Medical Center Research Institute, Inc. - Kansas City
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-06-07 |
| Est. Completion | 2026-04-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05396833
The ClinicalTrials.gov registry entry for NCT05396833 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic or Locally Advanced Unresectable Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Avelumab is the first listed.
NCT05396833 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05396833 about?
NCT05396833 is a clinical study titled "Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)". This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for tuvusertib in combin...
What is the current status of trial NCT05396833?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2022-06-07. Estimated completion is 2026-04-10.
What conditions does trial NCT05396833 study?
This clinical trial studies the following conditions: Metastatic or Locally Advanced Unresectable Solid Tumors.
What interventions are being tested in trial NCT05396833?
The interventions under investigation include: Avelumab (DRUG), Tuvusertib (DRUG), Lartesertib (DRUG).
Who is sponsoring clinical trial NCT05396833?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05396833 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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