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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study

Quick Facts

Study Start:2023-03-15
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05482893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Phanes Therapeutics
CONTACT
858-766-0852
clinical-trials@phanestx.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, 80218
United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15232
United States
MD Anderson Cancer Center, GI Medical Oncology Dept
Houston, Texas, 77030
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Phanes Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2028-04

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Gastric or Gastroesophageal Junction Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancer (BTC)