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Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 MAb, Administered Alone and in Combination with a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)
Sponsor: Phanes Therapeutics
Summary
This is a first-in-human, Phase 1/2, open-label, study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Mavrostobart (PT199) alone and in combination with a PD-1 inhibitor or chemotherapy.
Official title: A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients with Advanced Solid TuMORs, in CombiNation with a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination with ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-08-11
Completion Date
2028-08
Last Updated
2025-01-31
Healthy Volunteers
No
Interventions
Mavrostobart (PT199)
Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.
Tislelizumab
Anti-PD-1 monoclonal antibody 200 mg Q3W, inhibits the lymphocytes PD-1 receptors, blocking the ligands that would deactivate it and prevent an immune response.
Gemcitabine + nab-Paclitaxel
Dosing is per Standard of Care.
Docetaxel
Dosing is per Standard of Care.
Pemetrexed
Dosing is per Standard of Care.
Gemcitabine
Dosing is per Standard of Care.
Carboplatin + Pemetrexed
Dosing is per Standard of Care.
Pembrolizumab + Carboplatin + Pemetrexed
Dosing is per Standard of Care.
Locations (6)
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Tranquility Research
Webster, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States