Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Endometrial Cancer
  • Appendiceal Adenocarcinoma
  • Cervical Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Exocrine Pancreatic Adenocarcinoma
  • Gastric Cancer and Gastroesophageal Junction (GEJ) Carcinoma
  • Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
  • Non - Small Cell Lung Cancer NSCLC
  • Ovarian Cancer
  • Pseudomyxoma Peritonei
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will be gated based on data generated from other expansion cohorts and will require additional biopsies. At the completion of...

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will be gated based on data generated from other expansion cohorts and will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.

Tracking Information

NCT #
NCT04665921
Collaborators
Not Provided
Investigators
Study Director: Suzanne McGoldrick, MD Seagen Inc.
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