> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-in-human-study-of-ot-a201-in-patients-with-selected-19885de4-342b-45a6-84e4-f240dbb816c1 > Record changed: 2026-10-13 # First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors NCT05828459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Lead sponsor Onward Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Start date 2023-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Short title** First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Dates **Completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **First posted** 2023-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Registry last updated** 2025-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Primary completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Start date** 2023-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Lead sponsor** Onward Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Identifiers **Registry ID** NCT05828459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **ClinicalTrials.gov ID** NCT05828459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Sites - ICM - MontpellierMontpellier, FranceRecruiting - Saint-Eloi Hospital - Montpellier (CHU)Montpellier, FranceRecruiting - Saint-Joseph Hospital - ParisParis, FranceRecruiting - Centre Eugène MarquisRennes, FranceRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05828459) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) ### Lead sponsors (1) - [Onward Therapeutics](https://trialight.com/data/company/onward-therapeutics-fc60a5f0-ef9b-4a97-8832-a9afdb3d2282.md) ### Conditions (1) - [Hematopoietic and lymphoid system neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-system-neoplasm-510101ac-7ce5-5dd1-8980-f2f110effdf0.md) ### Targets (16) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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