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MinorTrial completedPrimary completion date changed from estimate of Jan 14, 2027 to Jul 14, 2026v28Show 1 more changeShow less
Primary completion date changed from estimate of Jan 14, 2027 to Jul 14, 2026
NotablePrimary and study completion pushed from Apr 10, 2026 to Jan 14, 2027v27
MinorPrimary and study completion dates: Apr 3, 2026 to Apr 10, 2026v26
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 123 to confirmed 120 · Study sites: 20 to 22v25Show 2 more changesShow less
Enrollment target: estimated 123 to confirmed 120
Study sites: 20 to 22
MinorRe-verified, no change to tracked fieldsv24
Show 22 earlier versionsHide 22 earlier versions
MinorPrimary completion date: Mar 31, 2026 to Apr 3, 2026Completion date: May 31, 2026 to Apr 3, 2026 · Site details revised at 7 of 20 sitesv23Show 2 more changesShow less
Completion date: May 31, 2026 to Apr 3, 2026
Site details revised at 7 of 20 sites
NotableEnrollment target: 72 to 123Study sites: 19 to 20v22Show 1 more changeShow less
Study sites: 19 to 20
Minor4 versionsRe-verified since Jan 29, 2025, no change to tracked fieldsv18-v21
MinorSite details revised at 3 of 19 sitesv17
MinorSite details revised at 4 of 19 sitesv16
MinorStudy sites: 5 to 19Eligibility criteria shortened, about 1 wordv15Show 1 more changeShow less
NotablePrimary completion date: Dec 12, 2023 to Mar 31, 2026Primary endpoints: 6 to 12 · Completion date: Dec 12, 2023 to May 31, 2026 · Eligibility criteria expanded, about 204 words · 2 morev12Show 5 more changesShow less
Minor5 versionsRe-verified since May 16, 2023, no change to tracked fieldsv7-v11
MinorInterventions: Drug A (DNA Damage Response Inhibitor) (Drug), Drug B (Immune Checkpoint Inhibitor) (Drug), M1774 (Drug) to Avelumab (Drug), M1774 (Drug), M4076 (Drug)Secondary endpoints revised (6)v6Show 1 more changeShow less
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of May 30, 2022 to Jun 7, 2022 · Site details revised at 5 of 5 sitesv3Show 2 more changesShow less
Start date changed from estimate of May 30, 2022 to Jun 7, 2022
Site details revised at 5 of 5 sites
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).