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MORNINGSTAR Study: Mavrostobart for Lung and Pancreatic Cancers

This study is testing a new drug called Mavrostobart (PT199), alone or with other treatments, for people with non-small cell lung cancer or pancreatic cancer. Mavrostobart is designed to make your immune system more active against cancer. Researchers want to find the safest and most effective dose of Mavrostobart, either by itself or when combined with Tislelizumab (a PD-1 inhibitor) or standard chemotherapy (like Gemcitabine + nab-Paclitaxel, Docetaxel, or Pemetrexed). To join, you must have advanced or metastatic solid tumors that have been treated before or for which other treatments aren't available. The study is currently enrolling about 40 participants to see how safe the drug is and how well it works.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll about 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor you from the start of the study drug until 90 days after your last dose to check for side effects and determine the best dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05431270

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Phanes Therapeutics
~40 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Mavrostobart (PT199)TislelizumabGemcitabine + nab-PaclitaxelDocetaxelPemetrexedGemcitabine

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the maximum tolerated dose (MTD), if reached.
Measured over Start of the study drug till 90 days after last dose.
+2 more outcomes measured

Conditions

Non Small Cell Lung Cancer
Pancreatic Ductal Adenocarcinoma

Explore related trials

Lung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid Neoplasm

Where it's being run

6 sites across 5 states
Texas2
North Carolina1
Oklahoma1
Tennessee1
Virginia1

Who to contact

Phanes Therapeutics
[email protected]
858-766-0852
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cohort D1: a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC), treatment naïve for advanced or metastatic disease, and eligible to receive standard of care treatment with gemcitabine plus nab-paclitaxel.
Cohort D2: 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. Patients have progressed under first-line (1L) SOC chemotherapy with or without ICI or later lines of therapy, or for which standard 1L therapy has proven to be ineffective, intolerable, or is considered inappropriate.
Cohort D3: a histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations. Patients are treatment naïve and have no contra indication to receive carboplatin plus pemetrexed.
Cohort D4: a histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations. Patients are treatment naïve and are eligible for 1L therapy with pembrolizumab and carboplatin plus pemetrexed. 3. In all Parts, should be able to provide a tumor tissue sample (archival or newly acquired biopsy) to be assessed for CD73 and other biomarkers (PD-L1), unless deemed by the Investigator to cause risk to the patient or per Investigator's discretion. 4. ECOG performance status of 0 or 1. 5. Adequate organ function confirmed at screening and within 72 hours of initiating treatment.

What this trial measures

  • To determine the maximum tolerated dose (MTD), if reached.Start of the study drug till 90 days after last dose.
  • Recommended Phase 2 Dose of Mavrostobart (PT199) as a single agent and/or in combination with a PD-1 inhibitor.Start of the study drug till 90 days after last dose.
  • Dose Limiting Toxicity (DLT).Time Frame: Start of the study drug till 90 days after last dose.