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NCT05482893PHASE1, PHASE2Recruiting

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)

Phanes Therapeutics

Start Date

3/15/2023

Completion Date

4/1/2028

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria 1. 18 years or older and able to sign informed consent and comply with the protocol. 2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors. 3. 3\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated. Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible. Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Part C, substudy C4: Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment. Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). 4. 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. 5. ECOG performance status of 0 or 1. 6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment. Key Exclusion Criteria Patients are excluded from the study if any of the following criteria apply: 1. Women who are pregnant or lactating. 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. Has an active autoimmune disease that has required systemic treatment in the past 2 years. 4. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. Additional inclusion and exclusion criteria will apply.

Interventions

DRUG

Spevatamig (PT886)

DRUG

Paclitaxel

DRUG

Gemcitabine

DRUG

Abraxane

DRUG

KEYTRUDA® (pembrolizumab)

DRUG

FOLFOX

DRUG

CAPOX

DRUG

FOLFIRINOX

Interested in This Trial?

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Conditions

Gastric or Gastroesophageal Junction AdenocarcinomaPancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)

Locations

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

Duarte, California 91010

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Sarah Cannon Research Institute (SCRI)

Denver, Colorado 80218

United States

University of Iowa

Iowa City, Iowa 52242

United States

Norton Cancer Institute

Louisville, Kentucky 40202

United States

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts 02215

United States

Duke Cancer Center

Durham, North Carolina 27710

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

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States