Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SW-682 · 1 trial · 2 indications
Safety and tolerability endpoint evaluation via incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment emergent adverse events (TEAE)
The maximum tolerated dose (MTD) for SW-682, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1.
The recommended dose for expansion (RDE) will be determined based on all safety, tolerability, pharmacokinetics (PK), preliminary antitumor efficacy, and other available data from Part 1 of the study.
Objective response rate (ORR), defined as the proportion of participants with confirmed CR or PR using RECIST v1.1, mRECIST for mesothelioma, and/or GCIG CA-125 for ovarian cancer, as applicable, assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose Escalation Cohorts Ranging in Dose | EXPERIMENTAL | Participants with advanced solid tumors with or without Hippo pathway mutations will receive SW-682 tablets administered orally in continuous 28-day cycles. SW-682 dosage and frequency of administration will vary by cohort. |
| Part 2 Dose Expansion Cohort 1 | EXPERIMENTAL | Participants with mesothelioma with or without NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data. |
| Part 2 Dose Expansion Cohort 2 | EXPERIMENTAL | Participants with advanced solid tumors with NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data. |
| Part 2 Dose Expansion Cohort 3 | EXPERIMENTAL | Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data. |
| Part 2 Dose Expansion Cohort 4 | EXPERIMENTAL | Participants will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data, with appropriate combination therapy, identified based on Part 1 data. |
| Name | Type | Description |
|---|---|---|
| SW-682 | DRUG | SW-682 tablet administered orally |
| Combination Therapy | DRUG | Appropriate combination therapy |
Key Inclusion Criteria: * Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SW-682 is an investigational small molecule being developed for the treatment of advanced solid tumors, including malignant mesothelioma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
SW-682 targets TEAD, a protein involved in tumor growth. By inhibiting TEAD, SW-682 aims to interfere with cancer cell proliferation in advanced solid tumors.
SW-682 is being developed by SpringWorks Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SWTX.
SW-682 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication.
SW-682 is being studied in a Phase 1 clinical trial with the identifier NCT06251310, titled 'SW-682 in Advanced Solid Tumors.' This trial is currently recruiting participants in the United States and has an estimated enrollment of 186 patients.