Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
Public ClinicalTrials.gov record NCT05482893. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05482893
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
- Spevatamig (PT886) Drug
- Paclitaxel Drug
- Gemcitabine Drug
- Abraxane Drug
- KEYTRUDA® (pembrolizumab) Drug
- FOLFOX Drug
- CAPOX Drug
- FOLFIRINOX Drug
- TAS 102 Drug
- Bevacizumab Drug
- Gemcitabine Combined With Cisplatin Drug
- NALIRIFOX Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2023 (Actual)
- Primary completion
- Dec 2027 (Estimated)
- Completion
- Apr 2028 (Estimated)
- Last update posted
- Sep 28, 2026
2023 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Sarah Cannon Research Institute (SCRI) | Denver | Colorado | 80218 | Recruiting |
| University of Iowa | Iowa City | Iowa | 52242 | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | Recruiting |
| Dana-Farber Cancer Institute (DFCI) | Boston | Massachusetts | 02215 | Active, not recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| MD Anderson Cancer Center, GI Medical Oncology Dept | Houston | Texas | 77030 | Recruiting |
| NEXT Oncology | Fairfax | Virginia | 22031 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05482893, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05482893 live on ClinicalTrials.gov.