Hematological Malignancy, Solid Tumor
Conditions
Brief summary
This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.
Interventions
DRUGOT-A201
OT-A201 IV infusion qw or q2w
DRUGIMids
Combination regimen for hematological malignancy Lenalidomide: 25 mg on Days 1 to 21 of each 28-day cycle; or Pomalidomide: 4 mg on Days 1 to 21 of each 28-day cycle
DRUGBevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
DRUGPaclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
DRUGTBD Compound
Combination regimen for hematological malignancy
Sponsors
Onward Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Monotherapy dose escalation followed by dose confirmation of combination regimens. Further expansion of each groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Histologically or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer * Measurable disease * Have had all available therapeutic standards for their disease * Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy * ECOG performance status ≤ 1 * Life expectancy \> 3 months as assessed by the investigator * Acceptable clinical lab results Main
Exclusion criteria
* Systemic steroids at a daily dose of \> 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed * Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy * Within 4 weeks of major surgery * Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months * Prior solid organ transplant * Primary or secondary immune deficiency * Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment * Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * Clinically significant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201 | 28 days | Evaluate dose-limiting toxicity (DLT) during the DLT observation period |
| Safety profile of OT-A201 | 6 months | Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations |
Countries
France
Contacts
Primary ContactBruno Piccolella
Backup ContactErica Wang
Outcome results
None listed