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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04787042 | Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 | PHASE1 | RECRUITING | 316 | — | — | Aug 6, 2021 | Dec 31, 2025 | Nov 15, 2024 | 6 | United States |
Patients will be enrolled at a dose level that is predicted to be the MTD
In patients experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy administered alone or in combination.
AE assessed by CTCAE 5.0
Investigator-assessed ORR, defined as either a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
| Arm | Type | Description |
|---|---|---|
| Phase 1a, Dose Escalation | EXPERIMENTAL | In the Phase 1a monotherapy study, the starting dose of ST-067 will be 30 μg/kg, with a total of 7 dose level cohorts planned. The starting dose for the IV infusion monotherapy dosing will be 60 µg/kg. Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. Up to 12 patients will be treated at the RP2D. |
| Phase 2, Expansion | EXPERIMENTAL | Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and microsatellite instability-high (MSI-Hi) tumors at the RP2D. |
| Phase 1a, Dose Escalation, ST-067 SC + Obinutuzumab Pre-treatment | EXPERIMENTAL | Patients will be treated every week with ST-067 in all cohorts. The DLT period is 28 days after the initial dose of ST-067. According to the mTPI schema initially there will be 3 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. The starting dose for ST-067 with obinutuzumab pre-treatment will be 120µg/kg. Obinutuzumab will be administered at 1000 mg daily via IV infusion on 2 consecutive days, with the first dose given at least 7 days prior to first dose of SC ST-067. |
| Phase 1 combination therapy | EXPERIMENTAL | Phase 1 dose escalation in combination with pembrolizumab will start at a dose of 30 µg/kg of ST-067 and 200 mg every 3 weeks of pembrolizumab. Patients will be treated every week with ST-067 and every three weeks with pembrolizumab. The MTD will be determined based on the mTPI design. |
| Name | Type | Description |
|---|---|---|
| ST-067 | BIOLOGICAL | ST-067 is an engineered variant of human interleukin-18. |
| Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA] | BIOLOGICAL | Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells. |
| pembrolizumab | BIOLOGICAL | Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody. |
Inclusion Criteria: 1. Male and female patients aged ≥18 years 2. Must provide written informed consent and any authorizations required by local law 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Have histologically or cytologically confirmed diagnosis of advanced/meta...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |