Title
A Phase 1/2, Open-Label, Dose Escalation and Expansion Study with PT886 followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction (GEJ), or Pancreatic Ductal AdEnocarcinomas of PT886, in Combination with either ChemotherApy, and/or the ChecKpoint Inhibitor Pembrolizumab (The TWINPEAK Study)

Description
A Phase 1/2, Open-Label, Dose Escalation and Expansion Study with Spevatamig (PT886) Followed by a Multi-cohorT Study in Patients with Advanced GastrIc, Gastroesophageal JuNction (GEJ), or Pancreatic Ductal AdEnocarcinomas of Spevatamig (PT886), in Combination with Either ChemotherApy, And/or the ChecKpoint Inhibitor Pembrolizumab. the TWINPEAK Study

Objective
Primary Objectives Parts A and B (Monotherapy Dose Escalation and Expansion):
-To determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD), if reached, of PT886 in patients with advanced or metastatic Gastric Adenocarcinoma (GC), Gastroesophageal Junction Adenocarcinoma (GEJ), or Pancreatic Ductal Adenocarcinoma.
-To evaluate the safety and tolerability of PT886
-To determine Recommended Dose for Expansion (RDE) of PT886 (Part A)

Secondary Objectives Parts A and B (Monotherapy Dose Escalation and Expansion):
-To evaluate the pharmacokinetics of PT886
-To evaluate the immunogenicity (ADA) of PT886
-To evaluate the preliminary efficacy of PT886 (Monotherapy Dose Expansion, Part B)

Primary Objectives Parts C and D (Combination Therapy):
-To evaluate tumor response in each individual combination cohort as measured by ORR.

Secondary Objectives Part C and D (Combination Therapy):
-To evaluate efficacy measured by disease control rate (DCR), progression free survival (PFS), 6-month overall survival (6-month OS) for Cohorts 1, 3, and 5, and overall survival (OS) for all Cohorts.
-To evaluate the safety of the combination of treatments.

Treatment 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, and pancreatic ductal adenocarcinoma (PDAC).

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Esophagus; Pancreas; Stomach

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital