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

ConditionsHematological Malignancy Solid Tumor

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorOnward Therapeutics

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 5 treatment groups

Group A: OT-A201 monotherapyExperimental treatment 1 intervention

Group B: OT-A201 in combination with iMiDExperimental treatment 2 interventions

Group C: OT-A201 in combination with a specific agentExperimental treatment 2 interventions

Group D: OT-A201 in combination with bevacizumabExperimental treatment 2 interventions

Group E: OT-A201 in combination with paclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

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

Time frame

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

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onward Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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