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)
NCT05482893 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 258
Last updated 2025-11-04
Summary
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).
Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Biliary Tract Cancer (BTC)
Interventions
- DRUG
-
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
- DRUG
-
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
- DRUG
-
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
- DRUG
-
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4
- DRUG
-
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C3
- DRUG
-
Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: Cohort C2
- DRUG
-
KEYTRUDA® (pembrolizumab)
Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D: Cohort D2, D3 and D4.
- DRUG
-
Spevatamig (PT886)
Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.
- DRUG
-
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C1
- DRUG
-
Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: Cohort C2
Sponsors & Collaborators
- collaborator INDUSTRY
-
Phanes Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-15
- Primary Completion
- 2027-12-31
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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