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

Primary Purpose

Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ELU001

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Folate Receptor Alpha, Carcinomas, Recurrent, Refractory, Folate Receptor alpha moderate expression, Folate Receptor alpha high expression, ELU001, Exatecan, C'Dot, C-Dot, Folic Acid, Payload, Nanoparticle, C'Dot drug conjugate, CDC, Linker, ELU-FRa-1, FOLR1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

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
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
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:

Active or ongoing 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").

Sites / Locations

Mayo Clinic - Phoenix, AZ
Mayo Clinic - Jacksonville, FLRecruiting
Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
Mayo Clinic - Rochester, MNRecruiting
Memorial Sloan Kettering Cancer CenterRecruiting
Duke University Medical Center - Duke Cancer InstituteRecruiting
Cleveland Clinic
Thomas Jefferson University, Sidney Kimmel Cancer CenterRecruiting
Women & Infants Hospital of Rhode IslandRecruiting
Avera Cancer InstituteRecruiting
Sarah Cannon Research Institute at Tennessee OncologyRecruiting
Mary Crowley Cancer ResearchRecruiting
New Experimental Therapeutics of San Antonio (NEXT Oncology)Recruiting
Fred Hutchinson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ELU001

Arm Description

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

Outcomes

Primary Outcome Measures

Part 1 Dose Escalation: The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha 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.

Part 2 Dose Expansion: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.

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.

Secondary Outcome Measures

Part 1 Dose Escalation: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors, per RECIST v1.1.

Part 1 and Part 2: To determine Duration of Response (DOR) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.

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.

Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.

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.

Full Information

NCT ID

NCT05001282

First Posted

July 14, 2021

Last Updated

October 3, 2023

Sponsor

Elucida Oncology

1. Study Identification

Unique Protocol Identification Number

NCT05001282

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2021 (Actual)

Primary Completion Date

June 15, 2024 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Elucida Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Endometrial Cancer, Ovary Cancer, Ovary Neoplasm, Ovary Disease, Ovary Metastasis, Ovarian Diseases, Ovarian Cancer Stage, Ovarian Epithelial Cancer, Ovarian Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Neoplasm Epithelial, Ovarian Cancer Recurrent, Endometrial Diseases, Endometrial Adenocarcinoma, Endometrial Carcinosarcoma, Endometrial Clear Cell Adenocarcinoma, Endometrioid Adenocarcinoma, Endometrial Neoplasms, Endometrial Cancer Recurrent, Endometrioid Tumor, Fallopian Tube Cancer, Peritoneal Cancer

Keywords

Folate Receptor Alpha, Carcinomas, Recurrent, Refractory, Folate Receptor alpha moderate expression, Folate Receptor alpha high expression, ELU001, Exatecan, C'Dot, C-Dot, Folic Acid, Payload, Nanoparticle, C'Dot drug conjugate, CDC, Linker, ELU-FRa-1, FOLR1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Dose Escalation Dose Expansion, Simon's 2-stage

Masking

None (Open Label)

Masking Description

Open Label

Allocation

N/A

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ELU001

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ELU001

Other Intervention Name(s)

FA-CDC

Intervention Description

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

Primary Outcome Measure Information:

Title

Part 1 Dose Escalation: The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.

Description

Time Frame

28 days

Title

Description

Time Frame

First dose of study drug until responses of CR or PR, assessed up to 12 months.

Secondary Outcome Measure Information:

Title

Description

Time Frame

First dose of study drug until responses of CR or PR, assessed up to 12 months.

Title

Part 1 and Part 2: To determine Duration of Response (DOR) of ELU001 for IV infusion in patients with over-expressing Folate Receptor Alpha tumors.

Description

Time Frame

Date of first response (CR or PR) until the date of disease progression or up to 12 months, whichever occurs first.

Title

Part 1 and Part 2: Number of participants with adverse events as assessed by CTCAE v5.0 Safety Evaluations.

Description

Time Frame

First dose of study drug up to 28 days after the last dose of study drug or up to 12 months, whichever occurs first.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: Active or ongoing 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").

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trial Operations

Phone

732-823-1182

clinicaltrialinfo@elucidaoncology.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eliel Bayever, MBBCh, MRCP

Organizational Affiliation

Elucida Oncology, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic - Phoenix, AZ

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Individual Site Status

Withdrawn

Facility Name

Mayo Clinic - Jacksonville, FL

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerardo Colon-Otero, MD

gcolonotero@mayo.edu

First Name & Middle Initial & Last Name & Degree

Yujie Zhao, MD, PhD

First Name & Middle Initial & Last Name & Degree

Steven Attia, DO

First Name & Middle Initial & Last Name & Degree

Saranya Chumsri, MD

First Name & Middle Initial & Last Name & Degree

Gerardo Colon-Otero, MD

First Name & Middle Initial & Last Name & Degree

Jeremy C Jones, MD

First Name & Middle Initial & Last Name & Degree

Yanyan Lou, MD

First Name & Middle Initial & Last Name & Degree

Rami Manochakian, MD

First Name & Middle Initial & Last Name & Degree

Kabir Mody, MD

First Name & Middle Initial & Last Name & Degree

Jason Starr, MD

First Name & Middle Initial & Last Name & Degree

Winston W Tan, MD

First Name & Middle Initial & Last Name & Degree

Colon-Otero Gerardo, M

Facility Name

Sarah Cannon Research Institute at Florida Cancer Specialists

City

Orlando

State/Province

Florida

ZIP/Postal Code

32827

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cesar A Perez Batista, MD

First Name & Middle Initial & Last Name & Degree

Cesar A Perez Batista, MD

First Name & Middle Initial & Last Name & Degree

Michel Valez, MD

First Name & Middle Initial & Last Name & Degree

Ernesto B Linares, MD

First Name & Middle Initial & Last Name & Degree

Osheka M Hansel, APRN

Facility Name

Mayo Clinic - Rochester, MN

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Wahner-Hendrickson, MD

First Name & Middle Initial & Last Name & Degree

Alex Adjei, MD, PhD

First Name & Middle Initial & Last Name & Degree

Thorvardur Halfdanarson, MD

First Name & Middle Initial & Last Name & Degree

Thanh P Ho, MD

First Name & Middle Initial & Last Name & Degree

Joleen M Hubbard, MD

First Name & Middle Initial & Last Name & Degree

Zhaohui Jin, MD

First Name & Middle Initial & Last Name & Degree

Sani H Kizilbash, MD, MPH

First Name & Middle Initial & Last Name & Degree

Roberto A Leon Ferre, MD

First Name & Middle Initial & Last Name & Degree

Konstantinos Leventakos, MD

First Name & Middle Initial & Last Name & Degree

Minetta C Liu, MD

First Name & Middle Initial & Last Name & Degree

Amit Mahipal, BS

First Name & Middle Initial & Last Name & Degree

Aaron S Mansfield, MD

First Name & Middle Initial & Last Name & Degree

Ciara O'Sullivan, MB, B.Ch

First Name & Middle Initial & Last Name & Degree

Andrea E Wahner Hendrickson, MD

First Name & Middle Initial & Last Name & Degree

Mojun Zhu, MD

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Information

Phone

646-888-4226

First Name & Middle Initial & Last Name & Degree

Yonina R Murciano-Goroff, MD, MsC

First Name & Middle Initial & Last Name & Degree

Alexander Drilon, MD

First Name & Middle Initial & Last Name & Degree

Allison Betof Warner, MD, PhD

First Name & Middle Initial & Last Name & Degree

Michelle Bradbury, MD, PhD

First Name & Middle Initial & Last Name & Degree

Yolanda C.D. Bryce, MD

First Name & Middle Initial & Last Name & Degree

Margaret Callahan, MD, PhD

First Name & Middle Initial & Last Name & Degree

Claire Friedman, MD

First Name & Middle Initial & Last Name & Degree

James Harding, MD

First Name & Middle Initial & Last Name & Degree

Komal Jhaveri, MD

First Name & Middle Initial & Last Name & Degree

Christopher Klebanoff, MD

First Name & Middle Initial & Last Name & Degree

Chrisann Kyi, MD

First Name & Middle Initial & Last Name & Degree

Bob Li, MD

First Name & Middle Initial & Last Name & Degree

Ezra Y Rosen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alison Schram, MD

First Name & Middle Initial & Last Name & Degree

Soo Ruym Yang, MD

First Name & Middle Initial & Last Name & Degree

Robert Young, MD

First Name & Middle Initial & Last Name & Degree

Dmitriy Zamarin, MD, PhD

Facility Name

Duke University Medical Center - Duke Cancer Institute

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27719

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carey Anders, MD

First Name & Middle Initial & Last Name & Degree

Carey Anders, MD

First Name & Middle Initial & Last Name & Degree

James Abbruzzese, MD

First Name & Middle Initial & Last Name & Degree

Gerard Blobe, MD PhD

First Name & Middle Initial & Last Name & Degree

Niharika Mettu, MD PhD

First Name & Middle Initial & Last Name & Degree

John Stricker, MD

First Name & Middle Initial & Last Name & Degree

David Hsu, MD PhD

First Name & Middle Initial & Last Name & Degree

Michael Morse, MD

First Name & Middle Initial & Last Name & Degree

Hope Uronis, MD

First Name & Middle Initial & Last Name & Degree

Nicholas Devito, MD

First Name & Middle Initial & Last Name & Degree

Evan Dropkin, PA

First Name & Middle Initial & Last Name & Degree

Carolyn Tashie, PA

First Name & Middle Initial & Last Name & Degree

Margo O'Neill, PA

First Name & Middle Initial & Last Name & Degree

Deanna Griffie, NP

First Name & Middle Initial & Last Name & Degree

Paula Kennedy-Newton, NP

First Name & Middle Initial & Last Name & Degree

Gretchen Kimmick, MD

First Name & Middle Initial & Last Name & Degree

Kelly Westbrook, MD

First Name & Middle Initial & Last Name & Degree

Jeremy Force, MD

First Name & Middle Initial & Last Name & Degree

Rita Deimler, NP

First Name & Middle Initial & Last Name & Degree

Rachel Pienknagura, PA

First Name & Middle Initial & Last Name & Degree

Rebecca Previs, MD

First Name & Middle Initial & Last Name & Degree

Sarah Collins, NP

First Name & Middle Initial & Last Name & Degree

Kimberly Nolte, PA

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen Wee Ma, MBBS

Facility Name

Thomas Jefferson University, Sidney Kimmel Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Babar Bashir, MD

First Name & Middle Initial & Last Name & Degree

Babir Bashir, MD

First Name & Middle Initial & Last Name & Degree

Maysa Abu-Khalaf, MD

First Name & Middle Initial & Last Name & Degree

Rita S Axelrod, MD

First Name & Middle Initial & Last Name & Degree

Jennifer M Johnson, DO, PhD

First Name & Middle Initial & Last Name & Degree

William K Kelly, DO

First Name & Middle Initial & Last Name & Degree

Daniel Lin, MD

First Name & Middle Initial & Last Name & Degree

Neil D Palmisiano, MD

First Name & Middle Initial & Last Name & Degree

James A Posey, MD

First Name & Middle Initial & Last Name & Degree

Russell J Schilder, MD

First Name & Middle Initial & Last Name & Degree

William J Tester, MD

First Name & Middle Initial & Last Name & Degree

Eleanor L Vanderklok, CRNP

First Name & Middle Initial & Last Name & Degree

Cynthia Wheeler, CRNP

Facility Name

Women & Infants Hospital of Rhode Island

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cara Mathews, MD

First Name & Middle Initial & Last Name & Degree

Cara Mathews, MD

First Name & Middle Initial & Last Name & Degree

Elizabeth Lokich, MD

First Name & Middle Initial & Last Name & Degree

Katherine Miller, MD

First Name & Middle Initial & Last Name & Degree

Ashley Stuckey, MD

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Rojas-Espaillat, MD

First Name & Middle Initial & Last Name & Degree

Luis Rojas-Espaillat, MD

First Name & Middle Initial & Last Name & Degree

David Starks, MD

Facility Name

Sarah Cannon Research Institute at Tennessee Oncology

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erika P Hamilton, MD

First Name & Middle Initial & Last Name & Degree

Todd M Bauer, MD

First Name & Middle Initial & Last Name & Degree

Howard A Burriss, MD

First Name & Middle Initial & Last Name & Degree

Benjamin Garmezy, MD

First Name & Middle Initial & Last Name & Degree

Melissa L Johnson, MD

First Name & Middle Initial & Last Name & Degree

Meredith McKean, MD

First Name & Middle Initial & Last Name & Degree

Meredith S Pelster, MD

First Name & Middle Initial & Last Name & Degree

David R Spigel, MD

Facility Name

Mary Crowley Cancer Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karina Amaro, Study Coord

ksmsto@marycrowley.org

First Name & Middle Initial & Last Name & Degree

Teresa Marquez, ClinTrialMg

tmarquez@marycrowley.org

First Name & Middle Initial & Last Name & Degree

Douglas Orr, MD

First Name & Middle Initial & Last Name & Degree

Jairo R Olivares, MD

First Name & Middle Initial & Last Name & Degree

Reva E Schneider, MD

First Name & Middle Initial & Last Name & Degree

Minal Barve, MD

Facility Name

New Experimental Therapeutics of San Antonio (NEXT Oncology)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NEXT Coordinators

Phone

210-580-9500

NXTSA_Coordinators@nextoncology.com

First Name & Middle Initial & Last Name & Degree

Anthony W Tolcher, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

David Sommerhalder, MD

First Name & Middle Initial & Last Name & Degree

Sridhar Beeram, MD

Facility Name

Fred Hutchinson Cancer Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth Swisher, MD

First Name & Middle Initial & Last Name & Degree

Elizabeth Swisher, MD

First Name & Middle Initial & Last Name & Degree

Kalyan Banda, MD

First Name & Middle Initial & Last Name & Degree

John Liao, MD Phd

First Name & Middle Initial & Last Name & Degree

Kathryn Pennington, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.elucidaoncology.com

Description

Elucida Oncology Corporate Website

Learn more about this trial

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

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