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

Solid Tumor Clinical Trial

Official title:

A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 as Monotherapy and in Combination Therapy in Patients With Selected Hematological Malignancies and Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828459
• Other study ID #: A20101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 10, 2023
• Est. completion date: July 2027

Study information

• Verified date: June 2023
• Source: Onward Therapeutics
• Contact: Bruno Piccolella
• Phone: +33 6 12 97 73 68
• Email: bruno.piccolella[@]onward-therapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms
• Solid Tumor

Intervention

Drug:
• OT-A201
OT-A201 IV infusion qw or q2w
• IMids
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
• Bevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
• Paclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
• TBD Compound
Combination regimen for hematological malignancy

Locations

Country	Name	City	State
France	ICM - Montpellier	Montpellier
France	Saint-Eloi Hospital - Montpellier (CHU)	Montpellier
France	Saint-Joseph Hospital - Paris	Paris
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Onward Therapeutics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201	Evaluate dose-limiting toxicity (DLT) during the DLT observation period	28 days
Primary	Safety profile of OT-A201	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	6 months