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)

Required: CLDN18 overexpression (≥ 10%; ≥ 2+ CLDN18.2 positive tumor cells)

Patients must present with ≥ 10%; ≥ 2+ CLDN18.2 positive TC in their tumor tissue

Required: HER2 (ERBB2) wild-type (HER2 negative)

Patients with m/a HER2 negative GC/GEJC

Required: PD-L1 (CD274) overexpression (PD-L1 CPS <1%)

present a PD-L1 CPS score of <1%

Allowed: HER2 (ERBB2) overexpression

Patients who are HER2 positive are eligible

Must have received: chemotherapy (GemCis) — first-line

Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI

Must have received: chemotherapy — first-line

Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy

Must have received: zolbetuximab (zolbetuximab)

Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab

Cannot have received: CLDN18.2 targeting therapy

Prior CLDN18.2...targeting therapies

Cannot have received: CD47 targeting therapy

Prior...CD47 targeting therapies

Cannot have received: SIRPA targeting agent

Exception: For Part D, Cohort D2, prior treatment with zolbetuximab is allowed.

Prior...SIRPα (signal regulatory protein alpha) targeting agents. For Part D, Cohort D2, prior treatment with zolbetuximab is allowed.