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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)

ConditionsNon Small Cell Lung CancerPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhanes Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.

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.

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.

Disqualifiers

Women who are pregnant or lactating.

Women of child-bearing potential (WOCBP) who do not use adequate birth control.

Autoimmune disease requiring systemic treatment within the past twelve months. Active autoimmune disease or a history of autoimmune diseases that may relapse.

Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Mavrostobart (PT199)

    Drug

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

  • Tislelizumab

    Drug

    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.

  • Gemcitabine + nab-Paclitaxel

    Drug

    Dosing is per Standard of Care.

  • Docetaxel

    Drug

    Dosing is per Standard of Care.

  • Pemetrexed

    Drug

    Dosing is per Standard of Care.

  • Gemcitabine

    Drug

    Dosing is per Standard of Care.

  • Carboplatin + Pemetrexed

    Drug

    Dosing is per Standard of Care.

  • Pembrolizumab + Carboplatin + Pemetrexed

    Drug

    Dosing is per Standard of Care.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Part A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part B: Combination Therapy Dose EscalationExperimental treatment 2 interventions
Group C: Part C: Combination Therapy Dose ExpansionExperimental treatment 2 interventions
Group D: Part D: Chemotherapy CombinationExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

To determine the maximum tolerated dose (MTD), if reached.

Time frame
Start of the study drug till 90 days after last dose.
2

Recommended Phase 2 Dose of Mavrostobart (PT199) as a single agent and/or in combination with a PD-1 inhibitor.

Time frame
Start of the study drug till 90 days after last dose.
3

Dose Limiting Toxicity (DLT).

Time frame
Time Frame: Start of the study drug till 90 days after last dose.

Secondary outcomes

1

Preliminary efficacy assessed by the response rate by RECIST 1.1 for overall response rate.

Time frame
Start of the study drug till 90 days after last dose.
2

Area Under the Curve from time 0 to last (AUC0-last) of Mavrostobart (PT199)

Time frame
Time Frame: Start of the study drug till 90 days after last dose.
3

Maximum Concentration (Cmax) of Mavrostobart (PT199)

Time frame
Time Frame: Start of the study drug till 90 days after last dose.
4

Half Life (T1/2) of Mavrostobart (PT199)

Time frame
Time Frame: Start of the study drug till 90 days after last dose.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phanes Therapeutics

Lead sponsor

BeiGene

Collaborator

Source ClinicalTrials.gov
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