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Also known as Spevatamig (PT886)
Spevatamig · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | An accelerated titration design will be employed for early dose levels, followed by the standard 3+3 design at higher dose levels. |
| Dose Expansion | EXPERIMENTAL | Two dose levels will be explored; the recommended dose for expansion (RDE) from Part A, and another dose level. |
| Combination Expansion with Chemotherapy | EXPERIMENTAL | Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Part C, substudy C4: 2L BTC patients will receive PT886 in combination with SOC chemotherapy mFOLFOX6. |
| Combination Expansion with KEYTRUDA® (pembrolizumab) | EXPERIMENTAL | Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). |
| Name | Type | Description |
|---|---|---|
| Spevatamig (PT886) | DRUG | Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47. |
| Paclitaxel | DRUG | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C1 |
| Gemcitabine | DRUG | Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2 |
| Abraxane | DRUG | Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2 |
| KEYTRUDA® (pembrolizumab) | DRUG | Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D. |
| FOLFOX | DRUG | Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only) |
| CAPOX | DRUG | Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) |
| FOLFIRINOX | DRUG | Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3 |
Key Inclusion Criteria 1. 18 years or older and able to sign informed consent and comply with the protocol. 2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors. 3. 3\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastri...
Spevatamig is an investigational small molecule being developed for the treatment of gastric or gastroesophageal junction adenocarcinoma. It is also being studied in pancreatic ductal adenocarcinoma and biliary tract cancer. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
Spevatamig is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated in oncology indications, including gastric and gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, and biliary tract cancer.
Spevatamig is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
Spevatamig is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted orphan drug and fast track designations by the FDA, reflecting its potential to address unmet medical needs in certain cancers.
Spevatamig is being studied in the TWINPEAK study (NCT05482893), a Phase 1 trial evaluating the drug as monotherapy or in combination with chemotherapy and/or immune checkpoint inhibitors. The trial is recruiting patients with advanced gastric, gastroesophageal junction, pancreatic ductal, or biliary tract carcinomas in the United States.
Yes, Spevatamig is also known as PT886. Both names refer to the same investigational drug being developed by Merck & Company, Inc. for the treatment of certain gastrointestinal cancers.