Solid Tumor
Conditions
Keywords
HDAC, Epigenetic, Histone, Acetylation
Brief summary
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.
Interventions
DRUGOBP-801
OBP-801 will be administered IV
Sponsors
Oncolys BioPharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2 | 4 weeks |
| Objective Response (OR) | 22 weeks |
| Durability of Objective Response (DOR) | 22 weeks |
Countries
United States
Outcome results
None listed