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

NCT05828459
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
150
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Lead sponsor
Onward Therapeutics
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Start date
2023-07-10
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Number of sites
4
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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.
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Short title
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-01
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First posted
2023-04-25
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Registry last updated
2025-03-20
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Primary completion date
2027-01-01
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Start date
2023-07-10
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Participants
150
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Participant count basis
Estimated
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Planned participants
150
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Onward Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05828459
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ClinicalTrials.gov ID
NCT05828459
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201

    Timeframe: 28 days

    Evaluate dose-limiting toxicity (DLT) during the DLT observation period

  2. Safety profile of OT-A201

    Timeframe: 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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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
Sources for eligibility
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  • ICM - MontpellierMontpellier, FranceRecruiting
  • Saint-Eloi Hospital - Montpellier (CHU)Montpellier, FranceRecruiting
  • Saint-Joseph Hospital - ParisParis, FranceRecruiting
  • Centre Eugène MarquisRennes, FranceRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (16)