Clinical trial · Interventional
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
A First-in-human, Phase I, Open-label Study of the ATM Inhibitor M4076 in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 410)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M4076 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1A Dose Escalation: M4076 100 mg
- description
- Participants received M4076 film coated tablets at a dose of 100 milligrams (mg), orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study
- interventionNames
- Drug: M4076
- type
- EXPERIMENTAL
- label
- Part 1A Dose Escalation: M4076 200 mg
- description
- Participants received M4076 film coated tablets at a dose of 200 mg, orally once daily in 21-day cycles, starting from Day 1 of each cycle disease progression, death, AE leading to discontinuation of study intervention(s), or withdrawal of consent, whichever occurred first, or End of Study.
- interventionNames
- Drug: M4076
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with advanced solid tumors, for whom no standard of care therapy exists or for whom is not considered sufficiently effective, or who cannot tolerate standard of care * Participants with Eastern Cooperative Oncology Group Performance status 0 or 1 * Adequate hematological, hepatic, and renal function as defined in the protocol * Participants in Part 1B (the preliminary food effect assessment) must agree to provide paired tumor biopsies if not contraindicated for medical reasons * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Clinically significant (i.e., active) uncontrolled intercurrent illness including, but not limited to: 1. Active infection (i.e., requiring systemic antibiotics or antifungals) 2. Uncontrolled arterial hypertension 3. Severe cardiac arrhythmia requiring medication 4. Cerebral vascular accident/stroke * Has known ataxia telangiectasia * Participants with tumors harboring previously identified ATM mutations * Participants with hypersensitivity to the active substance or to any of the excipients of M4076 * Other protocol defined exclusion criteria could apply
References
Publications (0)
Data not yet available