Actively 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)
Led by Phanes Therapeutics · Updated on 2025-11-04
258
Participants Needed
11
Research Sites
263 weeks
Total Duration
On this page
Sponsors
P
Phanes Therapeutics
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older and able to sign informed consent and follow the study plan
- Measurable disease by RECIST V1.1 criteria for solid tumors
- Histologically or cytologically confirmed unresectable advanced or metastatic gastric, gastroesophageal junction, biliary tract, or pancreatic carcinoma
- Specific cohorts for treatment combinations based on tumor type and prior therapy
- Ability to provide tumor tissue sample for CLDN18.2 testing; Parts C and D require ≥10% and ≥2+ CLDN18.2 positive tumor cells
- ECOG performance status of 0 or 1
- Adequate organ function within 72 hours before starting treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of child-bearing potential not using adequate birth control
- Active autoimmune disease requiring systemic treatment in past 2 years
- Need for systemic corticosteroids or immunosuppressive treatment within 14 days before study treatment
- History of pneumonitis requiring steroids, current pneumonitis, or interstitial lung disease
- Untreated or progressing brain or central nervous system metastases
- Prior therapies targeting CLDN18.2, CD47, or SIRPα (except zolbetuximab allowed in Part D, Cohort D2)
- Impaired heart function or significant heart diseases
- Prior hemolytic anemia or Evans Syndrome in last 3 months
- Active gastric perforation, bowel obstruction requiring intervention, or significant pleural/peritoneal effusion
- Thromboembolic events like deep vein thrombosis or pulmonary embolism in past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
7
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
8
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
MD Anderson Cancer Center, GI Medical Oncology Dept
Houston, Texas, United States, 77030
Actively Recruiting
10
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
11
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
P
Phanes Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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