Actively 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)
Led by Phanes Therapeutics · Updated on 2025-01-31
40
Participants Needed
6
Research Sites
311 weeks
Total Duration
On this page
Sponsors
P
Phanes Therapeutics
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
- For Part A: histologically or cytologically confirmed unresectable advanced or metastatic solid tumors previously treated or with no available or tolerated treatment.
- For Part B: confirmed diagnosis of NSCLC without actionable genomic alterations with disease progression on prior treatments, which may include checkpoint inhibitors, or metastatic/advanced PDAC with disease progression after prior therapies or no available/tolerated treatment.
- For Part C: confirmed diagnosis of NSCLC without actionable genomic alterations with disease progression on prior treatments, possibly including checkpoint inhibitors.
- For Part D:
- Cohort D1: confirmed PDAC, treatment-naïve for advanced/metastatic disease, eligible for gemcitabine plus nab-paclitaxel.
- Cohort D2: confirmed NSCLC without actionable genomic alterations with progression after first-line standard chemotherapy with or without immune checkpoint inhibitors or later lines.
- Cohort D3: confirmed NSCLC without actionable genomic alterations, treatment-naïve, no contraindication to carboplatin plus pemetrexed.
- Cohort D4: confirmed NSCLC without actionable genomic alterations, treatment-naïve, eligible for first-line pembrolizumab with carboplatin plus pemetrexed.
- Ability to provide tumor tissue sample for CD73 and biomarker assessment unless unsafe or at investigator discretion.
- ECOG performance status of 0 or 1.
- Adequate organ function confirmed at screening and within 72 hours of starting treatment.
You will not qualify if you...
- Pregnant or lactating women.
- Women of child-bearing potential not using adequate birth control.
- Autoimmune disease requiring systemic treatment within the past 12 months or active/history of autoimmune diseases that may relapse.
- Need for systemic corticosteroids or immunosuppressive treatment within 14 days prior to study treatment.
- History of Grade 3 or higher immune-related events such as pneumonitis, interstitial lung disease, myocarditis.
- Untreated or progressing brain or central nervous system metastases.
- Impaired cardiac function or significant cardiac diseases.
- Grade 3 or higher neuropathy.
- Recent wide-field radiotherapy within 4 weeks or limited field radiation within 2 weeks prior to study drug or unresolved adverse events from prior therapy.
- Current use of therapeutic doses of warfarin or other coumarin anticoagulants within 5 days before first study drug dose.
- Additional unspecified inclusion and exclusion criteria apply.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
2
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Tranquility Research
Webster, Texas, United States, 77598
Actively Recruiting
6
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
P
Phanes Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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