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

Onward Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor; Hematological Malignancy

Treatments: Drug: OT-A201; Drug: IMids; Drug: TBD Compound; Drug: Paclitaxel; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05828459

A20101

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

OT-A201 monotherapy

Experimental group

Description:

OT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.

Treatment:

Drug: OT-A201

OT-A201 in combination with iMiD

Experimental group

Description:

OT-A201 in combination with lenalidomide or pomalidomide at the approved dose

Treatment:

Drug: IMids

Drug: OT-A201

OT-A201 in combination with a specific agent

Experimental group

Description:

OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)

Treatment:

Drug: TBD Compound

Drug: OT-A201

OT-A201 in combination with bevacizumab

Experimental group

Description:

OT-A201 in combination with bevacizumab at the approved dose

Treatment:

Drug: Bevacizumab

Drug: OT-A201

OT-A201 in combination with paclitaxel

Experimental group

Description:

OT-A201 in combination with paclitaxel at the approved dose

Treatment:

Drug: Paclitaxel

Drug: OT-A201