Hematological MalignancyPhase 1NCT05828459
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
A Phase 1 study testing OT-A201, IMids and Bevacizumab in people with Hematological Malignancy and Solid Tumor, run by Onward Therapeutics at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Solid Tumor
- What is being tested?
- OT-A201, IMids and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Jul 2023to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
ICM - Montpellier
Montpellier
Jérémy Fleith, +33 (0)4 67 61 85 70, Jeremy.Fleith@icm.unicancer.fr
Diego Tosi, MD
- Recruiting
Saint-Eloi Hospital - Montpellier (CHU)
Montpellier
Cécile Popko, +33 (0)4 67 33 24 13, c-popko@chu-montpellier.fr
Guillaume Cartron, MD, PhD
- Recruiting
Saint-Joseph Hospital - Paris
Paris
Sandrine Rullé, +33 (0)1 44 12 32 41, srulle@ghpsj.fr
Eric Raymond, MD, PhD
- Recruiting
Centre Eugène Marquis
Rennes
Emilie Fouchet, +33 (0)2 99 25 44 09, e.fouchet@rennes.unicancer.fr
Héloise Bourien, MD
About this study
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
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.
- Conditions
- Hematological Malignancy, Solid Tumor
- Being tested
- OT-A201, IMids, Bevacizumab, Paclitaxel, TBD Compound
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-A201Drug
OT-A201 IV infusion qw or q2w
IMidsDrug
Also called lenalidomide, pomalidomide
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
BevacizumabDrug
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
PaclitaxelDrug
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
TBD CompoundDrug
Combination regimen for hematological malignancy
| Study group | Role | What they receive |
|---|---|---|
| OT-A201 monotherapy | Experimental | 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. Receives: Drug: OT-A201 |
| OT-A201 in combination with iMiD | Experimental | OT-A201 in combination with lenalidomide or pomalidomide at the approved dose Receives: Drug: OT-A201; Drug: IMids |
| OT-A201 in combination with a specific agent | Experimental | OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment) Receives: Drug: OT-A201; Drug: TBD Compound |
| OT-A201 in combination with bevacizumab | Experimental | OT-A201 in combination with bevacizumab at the approved dose Receives: Drug: OT-A201; Drug: Bevacizumab |
| OT-A201 in combination with paclitaxel | Experimental | OT-A201 in combination with paclitaxel at the approved dose Receives: Drug: OT-A201; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
Measured: 28 days
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start10 Jul 2023
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monotherapy dose escalation followed by dose confirmation of combination regimens. Further expansion of each groups.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onward Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Raymond, MD, PhD, Principal investigator, Saint-Joseph Hospital - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828459
- Sponsor's protocol ID
- A20101
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828459
- Acronym / sponsor ID
- A20101
- Conditions
- Hematological Malignancy, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Onward TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Monotherapy dose escalation followed by dose confirmation of combination regimens. Further expansion of each groups.
| Arm | Type | Receives |
|---|---|---|
| OT-A201 monotherapy | Experimental | Drug: OT-A201OT-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 | Experimental | Drug: OT-A201, Drug: IMidsOT-A201 in combination with lenalidomide or pomalidomide at the approved dose |
| OT-A201 in combination with a specific agent | Experimental | Drug: OT-A201, Drug: TBD CompoundOT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment) |
| OT-A201 in combination with bevacizumab | Experimental | Drug: OT-A201, Drug: BevacizumabOT-A201 in combination with bevacizumab at the approved dose |
| OT-A201 in combination with paclitaxel | Experimental | Drug: OT-A201, Drug: PaclitaxelOT-A201 in combination with paclitaxel at the approved dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OT-A201OT-A201 IV infusion qw or q2w | Drug | OT-A201 in combination with a specific agent, OT-A201 in combination with bevacizumab, OT-A201 in combination with iMiD, OT-A201 in combination with paclitaxel, OT-A201 monotherapy |
| IMidsAlso: lenalidomide, pomalidomideCombination 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 | Drug | OT-A201 in combination with iMiD |
| BevacizumabCombination regimen for solid tumor Bevacizumab: 10 mg/m² q2w | Drug | OT-A201 in combination with bevacizumab |
| PaclitaxelCombination regimen for solid tumor Paclitaxel: 175 mg/m² q3w | Drug | OT-A201 in combination with paclitaxel |
| TBD CompoundCombination regimen for hematological malignancy | Drug | OT-A201 in combination with a specific agent |
Primary outcome
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
Time frame: 28 days
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
Safety profile of OT-A201
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Raymond, MD, PhD principal investigator
Saint-Joseph Hospital - Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OT-A201, IMids and Bevacizumab in people with Hematological Malignancy and Solid Tumor, run by Onward Therapeutics at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Piccolella (+33 6 12 97 73 68, bruno.piccolella@onward-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.