Clinical trial for Gastric or Gastroesophageal Junction Adenocarcinoma
Official title 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)
ClinicalTrials.gov ID: NCT05482893
What this study is testing
What is Spevatamig (PT886)?
Spevatamig (PT886) is an investigational once‑weekly injectable medicine being studied as a potential treatment for gastric or gastroesophageal junction adenocarcinoma. Spevatamig (PT886) is designed to target Claudin 18.2 and CD47 in cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and tolerable Spevatamig is, how it behaves in the body, and if it shows early signs of working against these cancers.
- Who it's for
- It looks for adults with advanced, unresectable or metastatic gastric, GEJ, pancreatic, biliary tract, or colorectal cancer.
- What's involved
- Participants may receive Spevatamig alone or with other cancer drugs, attend regular clinic visits, and undergo blood tests and imaging to monitor safety and tumor response.
- Time commitment
- The trial lasts several months, with frequent visits for dosing, safety checks, and imaging as scheduled by the study team.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 1. 18 years or older and able to sign informed consent and comply with the protocol.
- Measurable disease as defined by RECIST V1.1 criteria for solid tumors.
- 3\. Part A: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary...
- Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be...
- ECOG performance status of 0 or 1.
You likely can't join if
- Women who are pregnant or lactating.
- Women of child-bearing potential (WOCBP) who do not use adequate birth control.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents.
See the full eligibility criteria
- Key 1. 18 years or older and able to sign informed consent and comply with the protocol.
- Measurable disease as defined by RECIST V1.1 criteria for solid tumors.
- 3\. Part A: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced...
- Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.
- ECOG performance status of 0 or 1.
- Adequate organ function confirmed at screening and within 72 hours of initiating treatment. Key
- Women who are pregnant or lactating.
- Women of child-bearing potential (WOCBP) who do not use adequate birth control.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. Additional inclusion and exclusion criteria will apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Durham, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; Iowa City, Iowa, United States; Louisville, Kentucky, United States; Durham, North Carolina, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.