First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOnward Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OT-A201
- IMids
- Bevacizumab
- Paclitaxel
- TBD Compound
Treatment groups
150 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov