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

Phase 1

Recruiting

• Conditions: Hematological Malignancy; Solid Tumor
• Interventions: Drug: OT-A201; Drug: IMids; Drug: TBD Compound; Drug: Bevacizumab; Drug: Paclitaxel

• Registration Number: NCT05828459
• Lead Sponsor: Onward Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OT-A201 monotherapy	OT-A201	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.
OT-A201 in combination with iMiD	IMids	OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
OT-A201 in combination with paclitaxel	OT-A201	OT-A201 in combination with paclitaxel at the approved dose
OT-A201 in combination with a specific agent	TBD Compound	OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
OT-A201 in combination with bevacizumab	OT-A201	OT-A201 in combination with bevacizumab at the approved dose
OT-A201 in combination with iMiD	OT-A201	OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
OT-A201 in combination with a specific agent	OT-A201	OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
OT-A201 in combination with bevacizumab	Bevacizumab	OT-A201 in combination with bevacizumab at the approved dose
OT-A201 in combination with paclitaxel	Paclitaxel	OT-A201 in combination with paclitaxel at the approved dose

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

ICM - Montpellier; 🇫🇷 Montpellier, France

Saint-Eloi Hospital - Montpellier (CHU); 🇫🇷 Montpellier, France

Saint-Joseph Hospital - Paris; 🇫🇷 Paris, France

Centre Eugène Marquis; 🇫🇷 Rennes, France