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

E

Elucida Oncology

Status and phase

Enrolling
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, is 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. ELU001 is a new chemical entity described as a C'Dot drug conjugate (CDC), consisting of payloads (exatecans) and targeting moieties (folic acid analogs) covalently bound by linkers to the C'Dot particle carrier. ELU001 will be the first drug-conjugate of its kind to be introduced into the clinic, a first in class, and a novel molecular entity.

Full 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 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 open for recruitment.

Enrollment

166 estimated 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").

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

166 participants in 1 patient group

ELU001
Experimental group
Description:
Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)
Treatment:
Drug: ELU001

Trial contacts and locations

18

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Central trial contact

Clinical Trial Operations

Data sourced from clinicaltrials.gov

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