Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
STK-012 · 1 trial · 4 indications
Incidence of TEAEs in participants with select advanced solid tumors
Incidence of SAEs in participants with select advanced solid tumors
Incidence of DLTs in participants with select advanced solid tumors
Incidence of death in participants with select advanced solid tumors
Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors
Incidence of SAEs at the RP2D in participants with select advanced solid tumors
Incidence of death at the RP2D in participants with select advanced solid tumors
To compare the ORR in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: STK-012 monotherapy dose escalation | EXPERIMENTAL | STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications |
| Phase 1a: STK-012 + pembrolizumab dose escalation | EXPERIMENTAL | STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications |
| Phase 1a: STK-012 + standard of care (SoC) dose escalation | EXPERIMENTAL | STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC |
| Phase 1b: STK-012 monotherapy expansion | EXPERIMENTAL | STK-012 SC monotherapy in selected solid tumor indications |
| Phase 1b: STK-012 + pembrolizumab dose expansion | EXPERIMENTAL | STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications |
| Phase 1b: STK-012 + SoC dose expansion | EXPERIMENTAL | STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC |
| Phase 2: Arm A | EXPERIMENTAL | STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
| Phase 2: Arm B | EXPERIMENTAL | STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
| Phase 2: Arm C | ACTIVE_COMPARATOR | SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC |
| Name | Type | Description |
|---|---|---|
| STK-012 | DRUG | Engineered Interleukin-2 (IL-2) selective for antigen activated T cells |
| pembrolizumab KEYTRUDA® | DRUG | anti-PD-1 monoclonal antibody |
| pemetrexed | DRUG | chemotherapy |
| carboplatin | DRUG | chemotherapy |
Selected Inclusion Criteria: 1. Phase 1: Selected advanced solid tumors 2. Phase 2: * Diagnosis of non-small cell lung cancer (NSCLC). * Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment. * Non-squamous (NSQ) cell histology. * No prior systemic therapy for advanc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
STK-012 is an investigational small molecule being studied for the treatment of advanced solid tumors, including non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and is being evaluated alone and in combination with other treatments in patients with advanced lung cancer and other cancers.
STK-012 is a small molecule, but its specific molecular target has not been disclosed. It is being studied in biomarker-selected patients with advanced solid tumors, including non-small cell lung cancer, to assess its safety and efficacy as a monotherapy and in combination with other treatments.
STK-012 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials for advanced solid tumors.
STK-012 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug alone and with other treatments in patients with advanced solid tumors.
STK-012 is being studied in a Phase 1 clinical trial with the identifier NCT05098132. This trial is recruiting patients with advanced solid tumors, including non-small cell lung cancer, and is being conducted in the United States, Georgia, Ireland, and Spain. The study is randomized and active-controlled.