Clinical trial · Interventional
A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
NCT02414516CI-TRIAL-00037571unknownPhase 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)
This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OBP-801 | Drug | HDAC Inhibitor OBP-801 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OBP-801
- interventionNames
- Drug: OBP-801
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 6 weeks
Secondary outcomes (3)
- measure
- Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2
- timeFrame
- 4 weeks
- measure
- Objective Response (OR)
- timeFrame
- 22 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: * Histologically or cytologically confirmed metastatic or unresectable solid tumor. * Has failed treatment with all standard therapies for their malignancy. * Adequate Karnofsky Performance Status. * An expected survival of at least 3 months. * Adequate organ and bone marrow function. * Signed informed consent form for study participation prior to screening. Patient Exclusion Criteria Patients presenting with any of the following will be excluded in the study: * Clinically significant disease as defined by the protocol. * Surgical therapy or other therapies within period as defined by the protocol. * Any condition that will interfere with compliance with the protocol as determined by investigator.
References
Publications (1)
- DERIVEDHeath EI, Weise A, Vaishampayan U, Danforth D, Ungerleider RS, Urata Y. Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2022 Apr;40(2):300-307. doi: 10.1007/s10637-021-01180-9. Epub 2021 Oct 6. PMID 34613570