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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)

NCT05431270 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-19

No results posted yet for this 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

Interventions

DRUG

Mavrostobart (PT199)

Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.

DRUG

Tislelizumab

Anti-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.

DRUG

Gemcitabine + nab-Paclitaxel

Dosing is per Standard of Care.

DRUG

Docetaxel

Dosing is per Standard of Care.

DRUG

Pemetrexed

Dosing is per Standard of Care.

DRUG

Gemcitabine

Dosing is per Standard of Care.

DRUG

Carboplatin + Pemetrexed

Dosing is per Standard of Care.

DRUG

Pembrolizumab + Carboplatin + Pemetrexed

Dosing is per Standard of Care.

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Phanes Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-11
Primary Completion
2027-12-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431270 on ClinicalTrials.gov