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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)
NCT05431270 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG Tislelizumab
- DRUG Mavrostobart (PT199)
- DRUG Gemcitabine + nab-Paclitaxel
Study Locations (6)
Texas
- The University of Texas MD Anderson Cancer Center — Houston
- Tranquility Research — Webster
North Carolina
- Carolina BioOncology Institute — Huntersville
Oklahoma
- Sarah Cannon Research Institute University of Oklahoma — Oklahoma City
Tennessee
- SCRI Oncology Partners — Nashville
Virginia
- NEXT Oncology — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05431270
The ClinicalTrials.gov registry entry for NCT05431270 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phanes Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05431270 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, North Carolina, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05431270 about?
NCT05431270 is a clinical study titled "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.
What is the current status of trial NCT05431270?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-08-11. Estimated completion is 2028-08.
What conditions does trial NCT05431270 study?
This clinical trial studies the following conditions: Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05431270?
The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), Tislelizumab (DRUG), Mavrostobart (PT199) (DRUG), Gemcitabine + nab-Paclitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05431270?
This trial is sponsored by Phanes Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05431270 being conducted?
This trial has 6 study locations across North Carolina, Oklahoma, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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