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RECRUITING
NCT05431270
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Mavrostobart (PT199)

Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.

DRUG

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.

DRUG

Gemcitabine + nab-Paclitaxel

Dosing is per Standard of Care.

DRUG

Docetaxel

Dosing is per Standard of Care.

DRUG

Pemetrexed

Dosing is per Standard of Care.

DRUG

Gemcitabine

Dosing is per Standard of Care.

DRUG

Carboplatin + Pemetrexed

Dosing is per Standard of Care.

DRUG

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