RecruitingPhase 1Phase 2NCT05482893

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 1/2, 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

Sponsor

Phanes Therapeutics

Enrollment

258 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called TWINPEAK) is testing a new drug called Spevatamig (PT886) — alone or in combination with chemotherapy or other cancer drugs — for people with advanced stomach, esophageal junction, pancreatic, or bile duct cancers. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic gastric, gastroesophageal junction (GEJ), pancreatic, or biliary tract (bile duct) cancer confirmed by biopsy - Your cancer has progressed or is not suitable for standard treatments - You have measurable disease on scans - The specific cohort you qualify for depends on your cancer type, prior treatments, and tumor characteristics (such as HER2 and PD-L1 status) **You may NOT be eligible if...** - You have not had the required number of prior treatments for the specific cohort - Your tumor characteristics do not match the cohort requirements - You have poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpevatamig (PT886)

Spevatamig (PT886) monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.

DRUGPaclitaxel

Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C1

DRUGGemcitabine

Chemotherapy as a combination partner to Abraxane and Spevatamig (PT886) in Part C: Cohort C2

DRUGAbraxane

Chemotherapy as a combination partner to Gemcitabine and Spevatamig (PT886) in Part C: Cohort C2

DRUGKEYTRUDA® (pembrolizumab)

Immune checkpoint inhibitor as a combination partner to Spevatamig (PT886) in Part D: Cohort D2, D3 and D4.

DRUGOxaliplatin

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

DRUGLeucovorin

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

DRUGFluorouracil

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

DRUGCapecitabine

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and Spevatamig (PT886) in Part D: Cohort D4

DRUGFOLFIRINOX

Chemotherapy as a combination partner to Spevatamig (PT886) in Part C: Cohort C3

Locations(11)

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

Duke Cancer Center

Durham, North Carolina, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center, GI Medical Oncology Dept

Houston, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05482893

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