RecruitingPhase 1Phase 2NCT05431270

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)

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)


Sponsor

Phanes Therapeutics

Enrollment

40 participants

Start Date

Aug 11, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called mavrostobart (PT199) — either alone or combined with another immunotherapy or chemotherapy — in people with advanced solid tumors. The drug is designed to help the immune system fight cancer by blocking a protein called CD73 that some tumors use to hide from the immune system. **You may be eligible if:** - You have advanced or metastatic solid tumors that have progressed on prior treatments - For the lung cancer group: you have non-small cell lung cancer (NSCLC) without certain genetic mutations, or advanced pancreatic cancer that has progressed on prior therapy - You have at least one measurable tumor that can be tracked on scans **You may NOT be eligible if:** - You have not received prior treatment for your cancer - Your tumor type does not match the specific groups being studied - Your overall health and organ function do not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DRUGCarboplatin + Pemetrexed

Dosing is per Standard of Care.

DRUGPembrolizumab + 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

View Full Details on ClinicalTrials.gov

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NCT05431270


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