Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
Onward Therapeutics (Voir sur ClinicalTrials)
juillet 2023
juillet 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Sandrine Rullé | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - Rennes - France | Emilie Fouchet | Contact (sur clinicalTrials) | |||
| ICM - Montpellier - Montpellier - France | Jérémy Fleith | Contact (sur clinicalTrials) | |||
| Saint-Eloi Hospital - Montpellier (CHU) - Montpellier - France | Cécile Popko | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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