Clinical trial · Interventional
Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53
NCT02143635CI-TRIAL-00051936completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
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 and Hematological TP53wt Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ancillary treatment | Drug | — | UNRESOLVED |
| HDM201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Drug: HDM201
- Drug: ancillary treatment
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: HDM201
- type
- EXPERIMENTAL
- label
- Arm C
- interventionNames
- Drug: HDM201
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria. * Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy. Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Prior treatment with compounds with the same mode of action * Subjects with significant or uncontrolled cardiovascular disease * History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism * Previous and concomitant therapy that precludes enrollment, as defined in the protocol * Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection * Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery * Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.