Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Neoplasm Metastasis

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Clear Cell

Ovarian Diseases

Fallopian Tube Neoplasms

Cystadenocarcinoma

Carcinoma, Endometrioid

Uterine Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Endocrine Gland Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Sarcoma

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Adenocarcinoma of the Appendix

Soft Tissue Sarcoma

Micronutrients

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Folic Acid

Vitamin B Complex

Exatecan

Folinic Acid

Folate

Vitamin B9

Dose Escalation: Escalating doses of ELU001 Dose Expansion: Recommended Dose for Expansion (or RP2D)

Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)

ELU001

Clinical Trial Operations

David J Park, MD

Gerardo Colon-Otero, MD

Colon-Otero Gerardo, M

David J Kahn, MD

Cesar A Perez Batista, MD

Srilata Gundala, MD

Michelle R Rowland, MD, Phd, MPH

Andrea Wahner-Hendrickson, MD

Clinical Trials Information

Yonina R Murciano-Goroff, MD, MsC

Carey Anders, MD

Wen Wee Ma, MBBS

Babar Bashir, MD

Babir Bashir, MD

Cara Mathews, MD

Luis Rojas-Espaillat, MD

Erika P Hamilton, MD

Karina Amaro, Study Coord

Teresa Marquez, ClinTrialMg

Douglas Orr, MD

NEXT Coordinators

Anthony W Tolcher, MD, FRCPC

Elizabeth Swisher, MD

Eliel Bayever, MBBCh, MRCP

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.

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.

Dose Escalation Dose Expansion, Simon's 2-stage

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

Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors

To determine the MTD and/or RP2D of ELU001 in patients with over-expressing Folate Receptor Alpha tumors. When at least 2 out of 6 patients in a given dose-level experience a dose-limiting toxicity (DLT), the dose is considered to have exceeded the MTD. The MTD, therefore, is defined as the previous highest tested dose of ELU001 that did not cause a DLT in the first cycle of treatment. In the event of emerging data during Part 1, the Sponsor may, in consultation with a dose-level safety review group, decide to define a recommended dose for expansion (in for Part 2) (RP2D) instead of the MTD. DLTs are defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to ELU001 treatment that result in a failure to meet the criteria for re-treatment.

Percentage of Participants with confirmed objective response as assessed by the investigator and per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR is defined as the disappearance of all target or non-target lesions. PR is defined as at least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

Time Measurement: DOR will begin at the date that a response has been identified (stable disease, partial response, or complete response) until the date of progressive disease (PD). PD is defined of at least a 20% increase in the sum of the longest diameters of the target lesions from data of initial response.

The number of participants Frequency/severity of abnormalities in vital signs measurements, physical examination findings, changes in clinical laboratory parameters, and incidence of adverse events after taking ELU001.

Elucida Oncology

Spots Global Cancer Trial Database for folate receptor alpha high expression