TrialPath
Recruiting

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 · Phanes Therapeutics
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study
About this 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).
Eligibility 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 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). 4. 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. 5. ECOG performance status of 0 or 1. 6. 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: 1. Women who are pregnant or lactating. 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. Has an active autoimmune disease that has required systemic treatment in the past 2 years. 4. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. Additional inclusion and exclusion criteria will apply.
Study design
Enrollment target: 258 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-15
Estimated completion: 2028-04
Last updated: 2026-07-09
Interventions
Drug: Spevatamig (PT886)Drug: PaclitaxelDrug: GemcitabineDrug: AbraxaneDrug: KEYTRUDA® (pembrolizumab)Drug: FOLFOXDrug: CAPOXDrug: FOLFIRINOX
Primary outcomes
  • To evaluate the safety and tolerability of Spevatamig (PT886) as monotherapy and in each individual combination substudy. (Through study completion, an average of 2 years)
  • To evaluate anti-tumor activity of PT886 as assessed by ORR, in Spevatamig (PT886) monotherapy and in each combination substudy. (Through study completion.)
  • To determine the recommended dose for expansion of Spevatamig (PT886) monotherapy. (Through study completion.)
Sponsor
Phanes Therapeutics · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactPhanes Therapeutics · contact · clinical-trials@phanestx.com · 858-766-0852
All locations (11)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Recruiting
Duarte, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Sarah Cannon Research Institute (SCRI)Recruiting
Denver, Colorado, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Dana-Farber Cancer Institute (DFCI)Active Not Recruiting
Boston, Massachusetts, United States
Duke Cancer CenterRecruiting
Durham, North Carolina, United States
University of Pittsburgh Medical Center (UPMC)Recruiting
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, GI Medical Oncology DeptRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
Fairfax, Virginia, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
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) · TrialPath