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)

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.

Trial Details

NCT ID

NCT05431270

Phase

PHASE1 / PHASE2

Sponsor

Phanes Therapeutics

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Mavrostobart (PT199)
Tislelizumab
Gemcitabine + nab-Paclitaxel
Docetaxel
Pemetrexed
Gemcitabine

Locations (sample)

Huntersville, North Carolina, United States|35.41069,-80.84285
Oklahoma City, Oklahoma, United States|35.46756,-97.51643
Nashville, Tennessee, United States|36.16589,-86.78444
Houston, Texas, United States|29.76328,-95.36327
Webster, Texas, United States|29.53773,-95.11826

Key Eligibility Criteria

At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
For Part A: a histologically or cytologically confirmed unresectable advanced or metastatic solid tumors previously treated with therapies, or for …
For Part B: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutati…
For Part C: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations such as EGFR or ALK mutations and…

For full eligibility, visit ClinicalTrials.gov.

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