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)
Recruiting · NCT05482893 · Interventional (participants receive a specific treatment) · Lead sponsor: Phanes Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 18 years or older and able to sign informed consent and comply with the protocol.
- Measurable disease as defined by RECIST V1.1 criteria for solid tumors.
- 3\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.
- Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.
- 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: Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.
- 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).
- 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.
- ECOG performance status of 0 or 1.
- Adequate organ function confirmed at screening and within 72 hours of initiating treatment.
- Key
Exclusion criteria
- Patients are excluded from the study if any of the following criteria apply:
- Women who are pregnant or lactating.
- Women of child-bearing potential (WOCBP) who do not use adequate birth control.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents.
- Additional inclusion and exclusion criteria will apply.
Where it is running
11 locations listed across 10 US states.
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Sarah Cannon Research Institute (SCRI) - Denver, Colorado, United States
- University of Iowa - Iowa City, Iowa, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- Dana-Farber Cancer Institute (DFCI) - Boston, Massachusetts, United States
- Duke Cancer Center - Durham, North Carolina, United States
- University of Pittsburgh Medical Center (UPMC) - Pittsburgh, Pennsylvania, United States
- MD Anderson Cancer Center, GI Medical Oncology Dept - Houston, Texas, United States
- NEXT Oncology - Fairfax, Virginia, United States
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison, Wisconsin, United States