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NCT05431270 · ClinicalTrials.gov registry record · Phase 1

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 study of Non-Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Phanes Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
6
Study locations

NCT05431270 is a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Phanes Therapeutics. The registered enrollment target is 40 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT05431270, a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Phanes Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
6
Study locations

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

Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma

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

FieldValue
Enrollment Target 40 participants
Start Date 2022-08-11
Est. Completion 2028-08
Phase Phase 1

Sponsor

Phanes Therapeutics

3 total trials

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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, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Phanes Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT05431270 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Texas, North Carolina, Oklahoma.

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.

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).

Who is sponsoring clinical trial NCT05431270?

This trial is sponsored by Phanes Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.