drugset / Trial / NCT05547321
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
Phase 1
Recruiting
150 enrolled
Oncomatryx Biopharma S.L.
Alcura Health España SA · collabAnapharm Bioanalytics · collabBiotrial Inc. · collabCTI Laboratory Services Spain · collabCentro de Investigación del Cáncer Universidad de Salamanca · collabCertara · collabClinigen, Inc. · collabEvidenze CRO · collabHistoOne · collabOpthimapharm · collabTFS Health Science · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.
Timeline
- Start
- 2022-10-20
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OMTX705 | Other / unclassified | 1 mg/kg | — |
| Subject | OMTX705 | Other / unclassified | 4 mg/kg | — |
| Subject | OMTX705 | Other / unclassified | 7.5 mg/kg | — |
| Subject | OMTX705 | Other / unclassified | 10 mg/kg | — |
| Subject | OMTX705 | Other / unclassified | 15 mg/kg | — |
| Subject | OMTX705 | Other / unclassified | 20 mg/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Background | Tislelizumab | Monoclonal antibody | 200 mg | — |
Indications
No indication recorded.