NCT05482893 - 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) | Biotech Hunter

Enrollment

258

Participants

Timeline

Start Date

March 15, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

April 30, 2028

Conditions

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

Interventions

DRUG

Spevatamig (PT886)

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

DRUG

Paclitaxel

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

DRUG

Gemcitabine

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

DRUG

Abraxane

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

DRUG

KEYTRUDA® (pembrolizumab)

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

DRUG

Oxaliplatin

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

DRUG

Leucovorin

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

DRUG

Fluorouracil

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

DRUG

Capecitabine

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

DRUG

FOLFIRINOX

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

Trial Locations (11)

15232

RECRUITING

University of Pittsburgh Medical Center (UPMC), Pittsburgh

22031

RECRUITING

NEXT Oncology, Fairfax

27710

RECRUITING

Duke Cancer Center, Durham

40202

RECRUITING

Norton Cancer Institute, Louisville

52242

RECRUITING

University of Iowa, Iowa City

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

77030

RECRUITING

MD Anderson Cancer Center, GI Medical Oncology Dept, Houston

80218

RECRUITING

Sarah Cannon Research Institute (SCRI), Denver

90033

RECRUITING

USC Norris Comprehensive Cancer Center, Los Angeles

91010

RECRUITING

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

02215

RECRUITING

Dana-Farber Cancer Institute (DFCI), Boston