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Mavrostobart

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: May 19, 2026

Target and mechanism

ModalitySmall molecule

Also known as Mavrostobart (PT199)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Mavrostobart · 1 trial · 2 indications

Phase 1 1
NCT05431270Dose 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)Non Small Cell Lung Cancer
RECRUITING40 Analytics
PHASE1RECRUITING
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)
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD), if reached.
Start of the study drug till 90 days after last dose.
Recommended Phase 2 Dose of Mavrostobart (PT199) as a single agent and/or in combination with a PD-1 inhibitor.
Start of the study drug till 90 days after last dose.
Dose Limiting Toxicity (DLT).
Time Frame: Start of the study drug till 90 days after last dose.

Secondary Endpoints

Preliminary efficacy assessed by the response rate by RECIST 1.1 for overall response rate.
Start of the study drug till 90 days after last dose.
Area Under the Curve from time 0 to last (AUC0-last) of Mavrostobart (PT199)
Time Frame: Start of the study drug till 90 days after last dose.
Maximum Concentration (Cmax) of Mavrostobart (PT199)
Time Frame: Start of the study drug till 90 days after last dose.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Monotherapy Dose EscalationEXPERIMENTALA standard 3+3 dose escalation design will be employed, and 3 patients will be enrolled initially at each dose level. Mavrostobart (PT199) will be administered as a monotherapy.
Part B: Combination Therapy Dose EscalationEXPERIMENTALA standard 3+3 dose escalation design will be employed, and 3 patients will be enrolled initially at each dose level. Patients will be treated with Mavrostobart (PT199) in combination with a PD-1 inhibitor, tislelizumab.
Part C: Combination Therapy Dose ExpansionEXPERIMENTALTwo RDEs for Part C will be determined in Part B and will be further evaluated in two dose expansion cohorts. Patients will be treated with Mavrostobart (PT199) in combination with a PD-1 inhibitor, tislelizumab.
Part D: Chemotherapy CombinationEXPERIMENTALThe Chemotherapy Combination Therapy Dose Escalation and Expansion will investigate four cohorts, one in frontline PDAC, two in frontline NSCLC and one in second-line and later NSCLC patients. Patients will receive Mavrostobart (PT199) plus chemotherapy, with one cohort also receiving pembrolizumab.

Interventions

NameTypeDescription
Mavrostobart (PT199)DRUGMavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.
TislelizumabDRUGAnti-PD-1 monoclonal antibody 200 mg Q3W, inhibits the lymphocytes PD-1 receptors, blocking the ligands that would deactivate it and prevent an immune response.
Gemcitabine + nab-PaclitaxelDRUGDosing is per Standard of Care.
DocetaxelDRUGDosing is per Standard of Care.
PemetrexedDRUGDosing is per Standard of Care.
GemcitabineDRUGDosing is per Standard of Care.
Carboplatin + PemetrexedDRUGDosing is per Standard of Care.
Pembrolizumab + Carboplatin + PemetrexedDRUGDosing is per Standard of Care.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about Mavrostobart

What is Mavrostobart used for?

Mavrostobart is an investigational small molecule being developed for the treatment of Non Small Cell Lung Cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with this type of cancer to evaluate its safety and efficacy.

What does Mavrostobart target?

Mavrostobart is an anti-CD73 monoclonal antibody that targets the CD73 protein. By targeting CD73, the drug aims to modulate the tumor microenvironment and enhance the body's immune response against cancer cells. This mechanism is being investigated in the context of Non Small Cell Lung Cancer treatment.

Who makes Mavrostobart?

Mavrostobart is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Non Small Cell Lung Cancer.

What phase is Mavrostobart in?

Mavrostobart is currently in Phase 1 clinical development. It is an investigational drug that has not yet received regulatory approval. The Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with Non Small Cell Lung Cancer.

What clinical trials is Mavrostobart in?

Mavrostobart is being studied in a Phase 1 clinical trial with the identifier NCT05431270. This trial is a dose escalation and expansion study that evaluates Mavrostobart administered alone and in combination with a PD-1 inhibitor or chemotherapy. The study is recruiting patients with Non Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma in the United States.

Is Mavrostobart the same as PT199?

Yes, Mavrostobart is also known as PT199. The drug is referred to by both names in clinical and research contexts. This alternative name is used in the clinical trial NCT05431270, which is investigating the drug for the treatment of Non Small Cell Lung Cancer.