RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2022-08-11
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05431270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Phanes Therapeutics
CONTACT
858-766-0852
clinical-trials@phanestx.com

Study Locations (Sites)

Carolina BioOncology Institute
Huntersville, North Carolina, 28078
United States
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Tranquility Research
Webster, Texas, 77598
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Phanes Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-11
Study Completion Date2028-08

Study Record Updates

Study Start Date2022-08-11
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Advanced
  • Metastatic
  • Refractory
  • Anti-CD73
  • Checkpoint immunotherapies
  • PD-1/PD-L1 inhibitors

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer
  • Pancreatic Ductal Adenocarcinoma