Clinical trial NCT05828459: First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematological Malignancy
Solid Tumor
Lead sponsor: Onward Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monotherapy dose escalation followed by dose confirmation of combination regimens.

Further expansion of each groups.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
timeFrame: 28 days
measure: Safety profile of OT-A201
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM - Montpellier
city: Montpellier
country: France
facility: Saint-Eloi Hospital - Montpellier (CHU)
city: Paris
country: France
facility: Saint-Joseph Hospital - Paris
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Saint-Joseph Hospital - Paris
name: Eric Raymond, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: