Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
| ClinicalTrials.gov Identifier |
| NCT05482893 |
| Institution Name |
| City of Hope, CA; USC Norris Comprehensive Cancer Center, CA; Sarah Cannon Research Institute Denver, CO; University of Iowa, IO; Norton Cancer Institute, KN; Duke Cancer Center, NC; University of Pittsburgh Medical Center, PA; MD Anderson Cancer Center, TX; NEXT Oncology, VA; University of Wisconsin Carbone Cancer Center, WI |
| Additional Institutions |
|
*Please reach out to Phanes Therapeutics, Inc, via information below for site specific information. Note: Financial assistance may be available via the clinical site. Need to discuss with specific site. |
| Principal Investigator |
| Please reach out to Phanes Therapeutics |
| Principal Investigator Phone |
| 858-766-0852 |
| Principal Investigator Email |
| [email protected] |
| Study Coordinator |
| n/a |
| Study Coordinator Phone |
| n/a |
| Study Coordinator Email |
| n/a |
| Study Overview |
| This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with biliary tract carcinoma (BTC), without actionable mutations, will be eligible for screening. |
| Enrollment Information |
| 40-60 (for BTC, estimated) |
| Study Start Date |
| 2023-03-01 |
| Study End Date |
| 2028-04-30 |
| 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. Monotherapy: Histologically or cytologically confirmed locally advanced or metastatic biliary tract carcinoma (gallbladder, intrahepatic, extrahepatic, ampullary) with progression on or intolerance of one line of prior systemic therapy in the advanced (locally advanced or metastatic) setting. Cohort C4: Patients with advanced BTC who have progressed on 1L of systemic therapy and are eligible for 2L FOLFOX treatment. 4. Biopsies: Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers. 5. ECOG performance status of 0 or 1. 6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment. |
| Exclusion Criteria |
|
1. Women who are pregnant or lactating. 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. Has an active autoimmune disease that has required systemic treatment in the past 2 years. 4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment. 5. Patients with a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or have a history of interstitial lung disease. History of COVID-19 pneumonia with fibrotic changes. 6. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases). 7. Prior receipt of CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. 8. Active gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention. 9. Patients with actionable genomic alteration positive disease (e.g., FGFR2 fusion or rearrangement, NRG1 fusion, RET fusion, IDH1 mutations, HER2 overexpression or amplification) |
| Financial Assistance Available |
| Yes |