Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.
NCT05547321 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-11-25
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.
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
OMTX705
The investigational product is OMTX705 administered as monotherapy at different escalation doses.
- DRUG
-
Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705.
- DRUG
-
OMTX705
The investigational product is OMTX705 administered as monotherapy at 10 mg/kg
- DRUG
-
OMTX705
The investigational product is OMTX705 administered as monotherapy at 15 mg/kg
- DRUG
-
OMTX705
The investigational product is OMTX705 administered as monotherapy at 7.5 mg/kg
- DRUG
-
Tislelizumab (BGB-A317)
Tislelizumab at 200 mg is administered in combination with OMTX705
- DRUG
-
OMTX705
The investigational product is OMTX administered at 4.0 mg/kg
Sponsors & Collaborators
-
Centro de Investigación del Cáncer Universidad de Salamanca
collaborator UNKNOWN -
CTI Laboratory Services Spain
collaborator UNKNOWN -
Anapharm Bioanalytics
collaborator UNKNOWN -
Certara
collaborator INDUSTRY -
Biotrial
collaborator INDUSTRY -
Alcura Health España SA
collaborator UNKNOWN -
Clinigen, Inc.
collaborator INDUSTRY -
Evidenze
collaborator UNKNOWN -
TFS Health Science
collaborator UNKNOWN -
HistoOne
collaborator UNKNOWN -
Opthimapharm
collaborator UNKNOWN -
Oncomatryx Biopharma S.L.
lead INDUSTRY
Principal Investigators
-
Ignacio García-Ribas, MD · Oncomatryx Biopharm, S.L.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-20
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
- Spain
Study Locations
More Related Trials
-
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
NCT05853367 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
NCT05581004 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors
NCT02715531 ·Status: COMPLETED ·Phase: PHASE1
-
Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
NCT06686745 ·Status: RECRUITING ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies
NCT06719362 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
NCT02410512 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
NCT03918278 ·Status: COMPLETED ·Phase: PHASE1
-
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT05098132 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of AMV564 in Subjects With Advanced Solid Tumors
NCT04128423 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Evaluate the Safety and Tolerability of EP0089
NCT07030478 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
NCT03313778 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
NCT06547957 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
NCT04857138 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
NCT05761223 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours
NCT04808362 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
NCT00569036 ·Status: COMPLETED ·Phase: PHASE1
-
Study of MK-7162 in Combination With Pembrolizumab (MK-3475) in Adult Participants With Advanced Solid Tumors (MK-7162-002)
NCT03364049 ·Status: COMPLETED ·Phase: PHASE1
-
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
NCT04130516 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors
NCT01618136 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT06716138 ·Status: RECRUITING ·Phase: PHASE1
-
AO-176 in Multiple Solid Tumor Malignancies
NCT03834948 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
NCT04047862 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
NCT06795412 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors
NCT02298387 ·Status: COMPLETED ·Phase: PHASE1
-
AMT-676 in Patients With Advanced Solid Tumors
NCT06400485 ·Status: RECRUITING ·Phase: EARLY_PHASE1