Non Small Cell Lung CancerPhase 1/2NCT05431270

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)

A Phase 1/2 study testing Mavrostobart (PT199), Tislelizumab and Gemcitabine + nab-Paclitaxel in people with Non Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma, run by Phanes Therapeutics at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
What is being tested?: Mavrostobart (PT199), Tislelizumab and Gemcitabine + nab-Paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 6 sitesUnited States
Study dates: 11 Aug 2022to Aug 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
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.

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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.
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.
ECOG performance status of 0 or 1.
Adequate organ function confirmed at screening and within 72 hours of initiating treatment.

Who cannot join

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.
Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.
Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.

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Impaired cardiac function or significant diseases.
Patients who have ≥ Grade 3 neuropathy.
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.
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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Phanes Therapeutics contact

858-766-0852

clinical-trials@phanestx.com

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

United States6 sites, 5 recruiting

NEXT Oncology
Fairfax, Virginia, 22031
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Recruiting
Sarah Cannon Research Institute University of Oklahoma
Oklahoma City, Oklahoma, 73104
Recruiting
Tranquility Research
Webster, Texas, 77598
Terminated

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients With Advanced Solid TuMORs, in CombiNation With a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination With ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)

Read the detailed description

Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action and is expected to completely inhibit CD73 enzyme activity. Mavrostobart (PT199) is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment, rendering anti-tumor immune cells to be more active and more responsive to checkpoint immunotherapies, such as PD-1/PD-L1 inhibitors.

CD73 is widely overexpressed in a number of different cancers, including pancreatic ductal adenocarcinoma (PDAC), gastric carcinoma, colorectal carcinoma, non-small cell lung cancer (NSCLC), sarcomas and glioblastomas. Thus, targeting CD73 may provide benefit for patients with a high CD73 expression in their tumor.

Mavrostobart (PT199) addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, especially in combination with PD-1 pathway inhibition, and thus offer a new treatment option for cancer patients.

NSCLC is known to have a high expression level of CD73, and emerging clinical data has shown that targeting CD73 may provide clinical benefit, when combined with an immune checkpoint inhibitor (ICI) and/or standard of care chemotherapies to overcome treatment resistance.

Conditions: Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
Being tested: Mavrostobart (PT199), Tislelizumab, Gemcitabine + nab-Paclitaxel, Docetaxel, Pemetrexed
Keywords: Advanced, Metastatic, Refractory, Anti-CD73, Checkpoint immunotherapies, PD-1/PD-L1 inhibitors
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mavrostobart (PT199)Drug
Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.
TislelizumabDrug
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-PaclitaxelDrug
Also called abraxane
Dosing is per Standard of Care.
DocetaxelDrug
Dosing is per Standard of Care.
PemetrexedDrug
Dosing is per Standard of Care.
GemcitabineDrug
Dosing is per Standard of Care.
Carboplatin + PemetrexedDrug
Dosing is per Standard of Care.
Pembrolizumab + Carboplatin + PemetrexedDrug
Dosing is per Standard of Care.

Study groups in NCT05431270
Study group	Role	What they receive
Part A: Monotherapy Dose Escalation	Experimental	A 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. Receives: Drug: Mavrostobart (PT199)
Part B: Combination Therapy Dose Escalation	Experimental	A 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. Receives: Drug: Mavrostobart (PT199); Drug: Tislelizumab
Part C: Combination Therapy Dose Expansion	Experimental	Two 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. Receives: Drug: Mavrostobart (PT199); Drug: Tislelizumab
Part D: Chemotherapy Combination	Experimental	The 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. Receives: Drug: Mavrostobart (PT199); Drug: Gemcitabine + nab-Paclitaxel; Drug: Docetaxel; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin + Pemetrexed; Drug: Pembrolizumab + Carboplatin + Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the maximum tolerated dose (MTD), if reached.
Measured: 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.
Measured: Start of the study drug till 90 days after last dose.
Dose Limiting Toxicity (DLT).
Measured: Time Frame: Start of the study drug till 90 days after last dose.

Secondary outcomes (7)

Preliminary efficacy assessed by the response rate by RECIST 1.1 for overall response rate.
Measured: 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)
Measured: Time Frame: Start of the study drug till 90 days after last dose.
Maximum Concentration (Cmax) of Mavrostobart (PT199)
Measured: Time Frame: Start of the study drug till 90 days after last dose.
Half Life (T1/2) of Mavrostobart (PT199)
Measured: Time Frame: Start of the study drug till 90 days after last dose.
Preliminary efficacy assessed by the response rate by RECIST 1.1 for disease control rate.
Measured: Time Frame: Start of the study drug till 90 days after last dose.
Progression free survival duration.
Measured: Time Frame: Start of the study drug till 90 days after last dose.
6-month overall survival.
Measured: Time Frame: Start of the study drug till 90 days after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 2022Aug 2028

First posted24 Jun 2022
Study start11 Aug 2022
Primary completionDec 2027 (estimated)
Study completionAug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: The study will consist of 4 parts: Monotherapy Dose Escalation (Part A), ICI Combination Therapy Dose Escalation (Part B), ICI Combination Dose Expansion in NSCLC (Part C), and Combination with Chemotherapy in frontline (1L) PDAC patients (Part D).
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05431270
Sponsor's protocol ID: PT199X1101
Status last verified: May 2026
First submitted: 25 May 2022
Last updated: 19 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients With Advanced Solid TuMORs, in CombiNation With a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination With ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)
ClinicalTrials.gov ID: NCT05431270
Acronym / sponsor ID: PT199X1101
Conditions: Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
Keywords: Advanced, Metastatic, Refractory, Anti-CD73, Checkpoint immunotherapies, PD-1/PD-L1 inhibitors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Phanes TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: BeiGene
Study start: 11 Aug 2022 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Aug 2028 (estimated)
First posted: 24 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: The study will consist of 4 parts: Monotherapy Dose Escalation (Part A), ICI Combination Therapy Dose Escalation (Part B), ICI Combination Dose Expansion in NSCLC (Part C), and Combination with Chemotherapy in frontline (1L) PDAC patients (Part D).

Arm	Type	Receives
Part A: Monotherapy Dose Escalation	Experimental	Drug: Mavrostobart (PT199)A 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 Escalation	Experimental	Drug: Mavrostobart (PT199), Drug: TislelizumabA 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 Expansion	Experimental	Drug: Mavrostobart (PT199), Drug: TislelizumabTwo 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 Combination	Experimental	Drug: Mavrostobart (PT199), Drug: Gemcitabine + nab-Paclitaxel, Drug: Docetaxel, Drug: Pemetrexed, Drug: Gemcitabine, Drug: Carboplatin + Pemetrexed, Drug: Pembrolizumab + Carboplatin + PemetrexedThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.
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.
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.

Key exclusion criteria (11 listed)

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.
Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mavrostobart (PT199)Mavrostobart (PT199) is an anti-CD73 mAb with a differentiated mechanism of action.	Drug	Part A: Monotherapy Dose Escalation, Part B: Combination Therapy Dose Escalation, Part C: Combination Therapy Dose Expansion, Part D: Chemotherapy Combination
TislelizumabAnti-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	Part B: Combination Therapy Dose Escalation, Part C: Combination Therapy Dose Expansion
Gemcitabine + nab-PaclitaxelAlso: abraxaneDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination
DocetaxelDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination
PemetrexedDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination
GemcitabineDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination
Carboplatin + PemetrexedDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination
Pembrolizumab + Carboplatin + PemetrexedDosing is per Standard of Care.	Drug	Part D: Chemotherapy Combination

Primary outcome

To determine the maximum tolerated dose (MTD), if reached.
Time frame: 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.
Time frame: Start of the study drug till 90 days after last dose.
Dose Limiting Toxicity (DLT).
Time frame: Time Frame: Start of the study drug till 90 days after last dose.

7 secondary outcomes

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.
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.
Maximum Concentration (Cmax) of Mavrostobart (PT199)
Time frame: Time Frame: Start of the study drug till 90 days after last dose.
Half Life (T1/2) of Mavrostobart (PT199)
Time frame: Time Frame: Start of the study drug till 90 days after last dose.
Preliminary efficacy assessed by the response rate by RECIST 1.1 for disease control rate.
Time frame: Time Frame: Start of the study drug till 90 days after last dose.
Progression free survival duration.
Time frame: Time Frame: Start of the study drug till 90 days after last dose.
6-month overall survival.
Time frame: Time Frame: Start of the study drug till 90 days after last dose.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Phanes Therapeutics contact

858-766-0852

clinical-trials@phanestx.com

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phanes Therapeutics (858-766-0852, clinical-trials@phanestx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD), if reached. (time frame: Start of the study drug till 90 days after last dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.