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)
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.
Description
Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action and is expected to completely inhibit CD73 enzyme activity. Mavrostobart (PT199) is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment, rendering anti-tumor immune cells to be more active and more responsive to checkpoint immunotherapies, such as PD-1/PD-L1 inhibitors. CD73 is widely overexpressed in a number of different cancers, including pancreatic ductal adenocarcinoma (PDAC), gastric carcinoma, colorectal carcinoma, non-small cell lung cancer (NSCLC), sarcomas and glioblast…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria 1. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors. 2. For Part A: a histologically or cytologically confirmed unresectable advanced or metastatic solid tumors previously treated with therapies, or for which treatment is not available or not tolerated. For Part B: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may include a checkpoint inhibitor, or patients diag…
Interventions
- DrugMavrostobart (PT199)
Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.
- DrugTislelizumab
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.
- DrugGemcitabine + nab-Paclitaxel
Dosing is per Standard of Care.
- DrugDocetaxel
Dosing is per Standard of Care.
- DrugPemetrexed
Dosing is per Standard of Care.
- DrugGemcitabine
Dosing is per Standard of Care.
- Drug
Locations (6)
- Carolina BioOncology InstituteHuntersville, North Carolina
- Sarah Cannon Research Institute University of OklahomaOklahoma City, Oklahoma
- SCRI Oncology PartnersNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Tranquility ResearchWebster, Texas
- NEXT OncologyFairfax, Virginia