Recruitment

Recruitment Status
Recruiting

Summary

Conditions
  • Gastroesophageal Junction Adenocarcinoma
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Rectal Neoplasms
  • Endometrial Neoplasms
  • Colorectal Carcinoma
  • Distal Cholangiocarcinoma
  • Colon Neoplasm
  • Rectum Carcinoma
  • Ovarian Cancer Recurrent
  • Breast Neoplasm
  • Rectum Cancer
  • Colon Cancer Liver Metastasis
  • Ovarian Carcinoma
  • Endometrial Cancer
  • Rectal Cancer, Metastatic
  • Hilar Cholangiocarcinoma
  • Colon Cancer
  • Colorectal Cancer Metastatic
  • Ovarian Diseases
  • Peritoneal Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Gastric Adenocarcinoma
  • Bile Duct Cancer
  • Colorectal Cancer Stage IV
  • Breast Cancer
  • TNBC - Triple-Negative Breast Cancer
  • Ovarian Serous Adenocarcinoma
  • Breast Cancer Stage
  • Triple -Negative Breast Cancer
  • Breast Cancer Metastatic
  • Endometrial Diseases
  • Rectal Cancer Stage
  • Fallopian Tube Cancer
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrioid Tumor
  • Colorectal Neoplasms
  • Colorectal Adenocarcinoma
  • Ovary Metastasis
  • Ovarian Neoplasm Epithelial
  • Esophageal Neoplasms
  • Ovarian Epithelial Cancer
  • Cholangiocarcinoma
  • Colon Cancer Stage
  • Colon Rectal Cancer
  • Intrahepatic Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma Recurrent
  • Ovary Cancer
  • Endometrial Cancer Recurrent
  • Breast Adenocarcinoma
  • Triple Negative Breast Neoplasms
  • Ovarian Adenocarcinoma
  • Breast Cancer Stage IV
  • Rectal Adenocarcinoma
  • Esophagus Cancer
  • Ovary Neoplasm
  • Colon Adenocarcinoma
  • Esophageal Cancer
  • Ovarian Cancer Stage
  • Endometrioid Adenocarcinoma
  • Endometrial Adenocarcinoma
  • Rectal Cancer (Stage III)
  • Endometrial Carcinosarcoma
  • Rectum Neoplasm
  • Rectal Cancer
  • Gastric Cancer Stage
  • Breast Cancer Invasive
  • Ovary Disease
Type
Interventional
Phase
Phase 1Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Dose Escalation Dose Expansion, Simon's 2-stageMasking: None (Open Label)
  • Masking Description: Open LabelPrimary Purpose: Treatment

Participation Requirements

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

Description

The study has two parts: Part 1 Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and Part 2 Tumor Group Expansion Cohort(s) where specific cancer types will be evaluated for efficacy and safety at the RP2D. Part 1, subjects with ca...

The study has two parts: Part 1 Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and Part 2 Tumor Group Expansion Cohort(s) where specific cancer types will be evaluated for efficacy and safety at the RP2D. Part 1, subjects with cancer types with a high likelihood of having FRα overexpressing tumors based on historical data, specifically, ovarian, endometrial, colorectal, gastric, gastroesophageal junction, triple negative breast, or non-small cell lung cancers, or cholangiocarcinoma, will be enrolled in a basket clinical study. Retrospective analysis of folate receptor alpha (FRα) expression status will be determined. Part 2 Stage 1 of a Simon's Two-Stage design, tumor group expansion cohorts, each consisting of subjects with cancer types studied as part of the basket in Part 1.

Locations

San Antonio, Texas, 78229
San Antonio, Texas, 78229

Tracking Information

NCT #
NCT05001282
Investigators
Study Director: Eliel Bayever, MBBCh, MRCP Elucida Oncology, Inc.