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)

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).

Trial Details

NCT ID
NCT05482893
Phase
PHASE1 / PHASE2
Sponsor
Phanes Therapeutics
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • Spevatamig (PT886)
  • Paclitaxel
  • Gemcitabine
  • Abraxane
  • KEYTRUDA® (pembrolizumab)
  • FOLFOX
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Denver, Colorado, United States|39.73915,-104.9847
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Louisville, Kentucky, United States|38.25424,-85.75941

Key Eligibility 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)…
  • 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 el…

For full eligibility, visit ClinicalTrials.gov.

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