First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

Launched by ONWARD THERAPEUTICS · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called OT-A201 for patients with certain types of blood cancers (hematological malignancies) and solid tumors, which are abnormal growths in organs like the lungs or breasts. The main goal of this early-stage study is to find out if OT-A201 is safe and how well it works when given alone or in combination with other treatments. The researchers will first test different doses to see which one is best tolerated by patients, and later look for signs that the treatment is helping to fight cancer.

To be eligible for this trial, participants should have a confirmed diagnosis of cancer that has either returned after treatment or is difficult to treat. They should also have measurable disease, meaning their cancer can be tracked, and have tried all standard treatments available for their condition. Other important criteria include having a good performance status (able to carry out daily activities) and a life expectancy of more than three months. Participants will need to undergo some initial tests, including a biopsy, to assess their condition before starting treatment. The trial is currently recruiting patients of all ages, and it’s important to note that those with certain health issues, like active infections or recent major surgeries, may not be able to participate.

Gender

ALL

Eligibility 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