Evaluating Mavrostobart for advanced lung and pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of Mavrostobart (PT199), an anti-CD73 monoclonal antibody, both alone and in combination with a PD-1 inhibitor or chemotherapy. It aims to inhibit CD73 enzyme activity to enhance immune response against tumors, particularly in patients with non-small cell lung cancer and pancreatic ductal adenocarcinoma. The study is structured in phases to assess pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with advanced or metastatic solid tumors. Participants will be monitored for their response to treatment and any adverse effects.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
2. For Part A: a histologically or cytologically confirmed unresectable advanced or metastatic solid tumors previously treated with therapies, or for which treatment is not available or not tolerated.

   For Part B: 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, or patients diagnosed with metastatic and/or advanced (m/a) PDAC who have disease progression after previously treated with therapies, or for which treatment is not available or not tolerated.

   For Part C: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may include a checkpoint inhibitor.

   For Part D:
   * 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.

Key Exclusion Criteria

1. Women who are pregnant or lactating.
2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.
3. Autoimmune disease requiring systemic treatment within the past twelve months. Active autoimmune disease or a history of autoimmune diseases that may relapse.
4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.
5. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.
6. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
7. Impaired cardiac function or significant diseases.
8. Patients who have ≥ Grade 3 neuropathy.
9. Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.
10. Patients who are currently receiving (last dose within 5 days from C1D1) treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.

Additional inclusion and exclusion criteria will apply.

Where it's running

• Carolina BioOncology Institute
  Huntersville, North Carolina, United States Recruiting
• Sarah Cannon Research Institute University of Oklahoma
  Oklahoma City, Oklahoma, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  Fairfax, Virginia, United States Recruiting
• Tranquility Research
  Webster, Texas, United States Terminated

Study contacts

• Study coordinator: Phanes Therapeutics
• Email: clinical-trials@phanestx.com
• Phone: 858-766-0852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.