A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced Gastrointestinal Cancers, Including GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, Targeted Therapy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study

Phanes Therapeutics

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), pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key 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. 3\. Part A: 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 B: Patients with PDAC and GC/GEJC must meet the same criteria as those in Part A depending on which…

Interventions

Drug
Spevatamig (PT886)
Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.
Drug
Paclitaxel
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C1
Drug
Gemcitabine
Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: substudy C2
Drug
Abraxane
Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: substudy C2
Drug
KEYTRUDA® (pembrolizumab)
Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D.
Drug
FOLFOX
Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab, Part D only)
Drug
CAPOX
Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886)
Drug
FOLFIRINOX
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3
Drug
TAS 102
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudies C5 and C7.
Drug
Bevacizumab
Targeted therapy as a combination partner to Spevatamig (PT886) in Part C: substudies C6 and C7.
Drug
Gemcitabine Combined With Cisplatin
Chemotherapy as a combination partner to Spevatamig (PT886) and KEYTRUDA® (pembrolizumab) in Part D: substudy D2
Drug
NALIRIFOX
Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: substudy C3.

Summary

Eligibility

Interventions

Locations (11)