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)

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
Phanes Therapeutics
Study ID
NCT05431270
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 11, 2022
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Monotherapy Dose Escalation
    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.
  • Experimental: Part B: Combination Therapy Dose Escalation
    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.
  • Experimental: Part C: Combination Therapy Dose Expansion
    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.
  • Experimental: Part D: Chemotherapy Combination
    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.

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. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Sarah Cannon Research Institute University of OklahomaOklahoma CityOklahoma73104-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Tranquility ResearchWebsterTexas77598-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in Huntersville, NC

By condition
Lung cancerPancreatic cancer
By specialty
OncologyLung oncologyLung diseaseGI oncology
By research site
Carolina BioOncology Institute· Huntersville, NCSarah Cannon Research Institute University of Oklahoma· Oklahoma City, OKSCRI Oncology Partners· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TXTranquility Research· Webster, TXNEXT Oncology· Fairfax, VA

Related Studies