Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05431270 | 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) | PHASE1 | RECRUITING | 40 | — | — | Aug 11, 2022 | Aug 1, 2028 | May 19, 2026 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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...