OncoMatch/Clinical Trials/NCT05482893
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)
Is NCT05482893 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments for gastric or gastroesophageal junction adenocarcinoma.
Treatment: Spevatamig (PT886) · Paclitaxel · Gemcitabine · Abraxane · KEYTRUDA® (pembrolizumab) · FOLFOX · CAPOX · FOLFIRINOX — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Esophageal Carcinoma
Gastric Cancer
Pancreatic Cancer
Cholangiocarcinoma
Biomarker criteria
Required: CLDN18 expression (testing required; no eligibility threshold specified)
tumor tissue sample...to be assessed for CLDN18.2 expression and other biomarkers
Required: HER2 (ERBB2) expression (testing required; no eligibility threshold specified)
Patients who are HER2 positive are eligible
Required: HER2 (ERBB2) wild-type
1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab)
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0 or 1
Prior therapy
Cannot have received: CLDN18.2 targeting therapy
Prior CLDN18.2...targeting therapies
Cannot have received: CD47 targeting therapy
Prior...CD47 targeting therapies
Cannot have received: SIRPA targeting agent
Prior...SIRPα (signal regulatory protein alpha) targeting agents
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Sarah Cannon Research Institute (SCRI) · Denver, Colorado
- University of Iowa · Iowa City, Iowa
- Norton Cancer Institute · Louisville, Kentucky
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05482893 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CLDN18.2 targeting therapy, CD47 targeting therapy, SIRPA targeting agent disqualifies patients from enrollment.
Does this trial require CLDN18?
Yes, CLDN18 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify