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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: Recruiting Phase 1 study of Pancreatic Ductal Adenocarcinoma and Biliary Tract Cancer (BTC), sponsored by Phanes Therapeutics.

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

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

FieldValue
Enrollment Target 258 participants
Start Date 2023-03-15
Est. Completion 2028-04
Phase Phase 1
Phanes Therapeutics

3 total trials

What NCT05482893 shows while recruiting

NCT05482893 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 598-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (57% lower).

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 lists 11 locations in 10 states (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.

Similar trials for Pancreatic Ductal Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05482893's enrollment target sits among peer trials

258 24th of 84 higher than 61 of 84 other Pancreatic Ductal Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05482893, the US trial registry maintained by the National Library of Medicine. NCT05482893 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.