Gastric

A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab Paclitaxel Regimen Versus the Standard Gemcitabine and nab-Paclitaxel Regimen for the Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma Cancer (MAPKeeper 301)

MOA: Atebimetinib (IMM-1 104) is a deep cyclic dual inhibitor of MEK1 and MEK2

Key Eligibility:

• Subjects’ initial diagnosis of metastatic pancreatic adenocarcinoma
  must have occurred ≤12 weeks prior to screening
• Subjects has ≥1 lesion measurable by CT/MRI
• Subjects with only localized disease are excluded
• Subjects with squamous, adenosquamous, neuroendocrine, or
  acinar pancreatic carcinoma are excluded
• Subjects that have received prior treatment for disease, except for
  palliative radiation or stent placement, are excluded
• Subjects that have received prior adjuvant therapy for disease are
  excluded, unless ≥6 months have passed since the last dose and
  there are no ongoing treatment-related toxicities.
  • Prior neoadjuvant therapy is permitted

A Phase 2/3 Interventional Study Of PF-08634404 In Combination With Chemotherapy In Treatment-Naïve Participants With Locally Advanced Or Metastatic Gastric, Gastroesophageal Junction, Or Esophageal Adenocarcinoma

MOA: PF-08634404 is a recombinant anti-PD-1 and anti-VEGF human mAb

Key Eligibility Criteria:

• Histologically or cytologically confirmed gastric, GEJ, or EAC that is locally advanced unresectable or metastatic
• No prior systemic therapy for advanced or metastatic disease
  • Subjects who received neo/adjuvant therapy or chemoradiation and recur
    or develop metastatic disease within 6mo of stopping treatment will count
    as having prior therapy and are not eligible
• Subjects should have PD-L1 tumor expression (TAP ≥1% or CPS ≥1)
  and HER2-negative status based on local testing results
• Squamous cell or undifferentiated gastroesophageal cancer are
  excluded
• Subjects with prior exposure to anti-VEGF therapy or cancer
  immunotherapy are excluded
  • Prior treatment with an approved PD-1/PD-L1 inhibitor in the peri
    operative setting is allowed if the treatment was completed > 9 months
    prior to enrollment

A Multicenter, Randomized, Open-label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-line Treatment in Participants with Unresectable, Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction (GEJ) Cancer

MOA: Trastuzumab deruxtecan (TDXd) is a HER2- directed ADC

Key Eligibility Criteria:

• Previously untreated, unresectable, locally advanced or metastatic HER2-positive gastric or GEJ cancer
• Centrally determined tumor PD-L1 CPS
  • Main Cohort: PD-L1 CPS ≥1
  • Exploratory Cohort: PD-L1 CPS <1
• Must provide a tumor sample for tissue-based IHC staining
• At least 1 target measurable lesion on CT or MRI
• Subjects with prior exposure to HER2-targeted therapy are excluded
• Subjects with known DPD enzyme deficiency are excluded

D702AC00001: A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer. (ARTEMIDE-Gastric01)

MOA: Rilvegostomig is a bispecific antibody with an engineered triple-mutant Fc domain targeting PD-1 and TIGIT.

Key Eligibility Criteria:

• Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ cancer
• HER2-positive (IHC 3+ or IHC 2+ ISH-positive) on a tumor biopsy
• Central laboratory confirmed PD-L1 CPS ≥ 1 by PD-L1 expression
• Subjects with lack of physiological integrity of the upper gastrointestinal tract are excluded
• Subjects with known partial or total DPD enzyme deficiency are excluded