A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

Elucida Oncology

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Ovarian Neoplasms

Ovarian Cancer Stage

Ovarian Carcinoma

Fallopian Tube Cancer

Ovarian Adenocarcinoma

Endometrial Cancer

Ovary Disease

Ovarian Neoplasm Epithelial

Ovary Metastasis

Endometrioid Adenocarcinoma

Endometrial Carcinosarcoma

Ovarian Epithelial Cancer

Peritoneal Cancer

Ovarian Cancer

Endometrial Cancer Recurrent

Endometrial Neoplasms

Ovary Cancer

Endometrial Adenocarcinoma

Endometrial Clear Cell Adenocarcinoma

Endometrial Diseases

Endometrioid Tumor

Ovarian Cancer Recurrent

Ovary Neoplasm

Ovarian Diseases

Ovarian Serous Adenocarcinoma

Treatments

Drug: ELU001

Study type

Interventional

Funder types

Industry

Identifiers

NCT05001282

ELU-FRα-1

Details and patient eligibility

About

This study, ELU- FRα-1, was focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available.

Full description

The study had 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 1 is currently closed for further recruitment.

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. Part 2 is closed for recruitment.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Patients must meet the following criteria to enroll in this study:

Part 1 Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma
Part 2 Ovarian Cancer or Endometrial Cancer
No other meaningful life-prolonging therapy option available
Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of ELU001 for folate receptor alpha (FRα) expression analysis. Previous FRα expression test results may be used in certain circumstances
Adequate organ function
Measurable disease, or in the absence of measurable disease, non-measurable disease as per Response evaluation criteria in solid tumors (RECIST) v1.1
Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; Part 2: ECOG performance status of 0 or 1.
Recovered from previous surgeries
Agree to highly effective contraception, not to get pregnant, or for men, not father a child during study participation

Key Exclusion Criteria:

Patients who meet any of the following are not eligible to enroll in this study:

Clinically significant eye disorders
Taken any treatments that use the protein folate receptor alpha or FRα to work
Taken any other experimental treatments
History of significant cardiac issues or other cancers within 3 years.
Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g., not enough platelets in your blood - platelets held stop bleeding in your body)
Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.
If you are pregnant.
Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE (systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress your immune system.
Part 1: if your cancer has spread to your brain.
Part 2: You can have cancer that has spread to your brain but there are exceptions. The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3 cm, there can be no evidence on a scan that shows your brain tissue has shifted from its expected position inside the skull (called "herniation") or be bleeding in the skull or brain itself (called "hemorrhage").