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NCT05482893 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Pancreatic Ductal Adenocarcinoma and Biliary Tract Cancer (BTC), sponsored by Phanes Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 258
- Enrollment target
- 11
- Study locations
NCT05482893 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Biliary Tract Cancer (BTC) that is actively recruiting participants, run by Phanes Therapeutics. The registered enrollment target is 258 participants, below the 598-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (57% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT05482893, a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Biliary Tract Cancer (BTC), is actively recruiting participants, sponsored by Phanes Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 258 participants
- Enrollment target
- 11
- Study locations
Study 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) and pancreatic ductal adenocarcinoma (PDAC).
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Abraxane
- DRUG KEYTRUDA® (pembrolizumab)
- DRUG Spevatamig (PT886)
Study Locations (11)
California
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte
- USC Norris Comprehensive Cancer Center - Los Angeles
Colorado
- Sarah Cannon Research Institute (SCRI) - Denver
Iowa
- University of Iowa - Iowa City
Kentucky
- Norton Cancer Institute - Louisville
Massachusetts
- Dana-Farber Cancer Institute (DFCI) - Boston
North Carolina
- Duke Cancer Center - Durham
Pennsylvania
- University of Pittsburgh Medical Center (UPMC) - Pittsburgh
Texas
- MD Anderson Cancer Center, GI Medical Oncology Dept - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05482893
The ClinicalTrials.gov registry entry for NCT05482893 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 598-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (57% lower). The listed sponsor is Phanes Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Paclitaxel is the first listed.
NCT05482893 reports 11 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Iowa.
Frequently Asked Questions
What is clinical trial NCT05482893 about?
NCT05482893 is a clinical study titled "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)". 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 sc...
What is the current status of trial NCT05482893?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2023-03-15. Estimated completion is 2028-04.
What conditions does trial NCT05482893 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Gastric or Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT05482893?
The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), Abraxane (DRUG), KEYTRUDA® (pembrolizumab) (DRUG), Spevatamig (PT886) (DRUG).
Who is sponsoring clinical trial NCT05482893?
This trial is sponsored by Phanes Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05482893 being conducted?
This trial has 11 study locations across California, Colorado, Iowa, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.