Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Mixed Tumor, Mullerian

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Malignant Mixed Mullerian Tumor

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Mitogens

Antineoplastic Agents, Immunological

400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.

Initial Dose = 400 mg/m\^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m\^2 IV Over 60 Minutes.

Judith Wolf, MD

The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer.

Primary Objective:

1. To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer.

Secondary Objectives:

1. To determine the duration of disease control, time to disease progression, and survival of this cohort of patients.
2. To determine the nature and degree of toxicity of cetuximab in this cohort of patients.
3. To correlate biologic markers with response to therapy if tissue is available.

The epidermal growth factor receptor (EGFR) is a large protein that plays an important role in tumor growth. When EGFR is stimulated or "overexpressed," a series of chemical reactions happen that result in a tumor being "told" to grow. Researchers know that EGFR is overexpressed in many types of endometrial cancer. Cetuximab is designed to block this receptor, which may help to stop or slow the growth of tumors in those patients whose endometrial cancer has come back.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. If you have had some of the tests done recently, they may not need to be repeated. Your complete medical history will be recorded. You will have a physical exam, including a pelvic exam and measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Blood (about 2-3 teaspoons) will be drawn for routine tests, tests of your kidney and liver function, and a pregnancy test for women who are able to have children. The pregnancy test must be negative for you to be allowed to take part in this study. You will have a chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (stomach and hip area) to measure the tumor.

If you are found to be eligible to take part in this study, you will receive cetuximab once a week through a needle in a vein. Each treatment cycle is 4 weeks long. In the first week of your first treatment cycle only, you will receive cetuximab over 120 minutes (2 hours). For all additional treatments, you will receive cetuximab over 60 minutes. During the infusion and for 60 minutes after the infusion ends, you will be closely watched for signs of an allergic reaction.

You will receive diphenhydramine (or a similar antihistamine) by vein, about 30-60 minutes before receiving each cetuximab infusion. This is in order to lower the risk of side effects that the study drug may cause. Your doctor may decide to lower the dose of diphenhydramine in later doses.

Before each cycle of therapy and 1 month after treatment ends, you will have a physical exam. Blood (about 2-3 teaspoons) will be drawn for routine tests. CT scans or MRI will be repeated every 2-3 cycles and at the end of treatment. If you have any tumors in your chest, a chest x-ray will be repeated every 2-3 cycles and at the end of treatment. If you have a partial or complete response (the tumor shrinks or disappears completely) or the disease is stable (where the tumor has neither grown nor shrunk), the CT or MRI will be repeated 4 weeks later to check the response.

You will be able to keep receiving additional treatment cycles as long as you are benefitting. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study.

After you have completed treatment on the study, the status of your health and the disease will be checked. Your doctor will decide how often these check-ups will occur. You may return to M. D. Anderson for these follow-up exams, or if you choose not to come in to the clinic, you will be contacted by phone to see how you are doing.

This is an investigational study. Cetuximab is commercially available and FDA approved for the treatment of colorectal cancer. Its use in the treatment of endometrial cancer in this study is experimental. Up to 40 patients will take part in this study. Up to 30 patients will be enrolled at M. D. Anderson.

Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer

Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer

Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.

Bristol-Myers Squibb

M.D. Anderson Cancer Center

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Judith Wolff, MD / Professor

There were ten inevaluable participants (completing less than 1 cycle).

Overall Disease Control Rate

Overall Study

Gland and Hormone Related Diseases

Carcinoma

Adenocarcinoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinosarcoma

Adenocarcinoma, Clear Cell

Ovarian Diseases

Fallopian Tube Neoplasms

Cystadenocarcinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Endocrine Gland Neoplasms

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Sarcoma

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Soft Tissue Sarcoma

Micronutrients

Hematinics

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

Anti-Infective Agents

Letrozole

Sirolimus

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Patients with advanced or recurrent endometrioid endometrial carcinoma

Prospective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients

nab-sirolimus

Aadi Bioscience Medical Information

Aaron Holley

Matthew Kovak

Michelle McClosky

Brian Slomovitz, MD

Thania Escamilla

Jacky Amador

Nicola M Spirtos, MD

Angela Green, MD

Leah J Wilson, BS, RN, OCN

Allison M Puechi, MD

Christine Pappaterra

Lauren Dockery, MD

Pamela Smith

Shelly Maxfield, CCRP

Anna Priebe, MD

Anh Lam

Fernanda Musa, MD

Willis Navarro, MD

A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer

This is a prospective phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma who have received 0-1 prior lines of chemotherapy in the recurrent/metastatic setting. Patients will be treated with nab-sirolimus (given IV on Days 1 and 8 in a 21-day cycle, combined with letrozole (orally, daily) until unacceptable toxicity or disease progression, or until in the opinion of the Investigator the patient is no longer benefiting from therapy, or at patient discretion.

Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer

A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer

ORR, defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using RECIST v1.1.

Determined for patients with BOR of confirmed CR or PR

BOR of confirmed CR or PR (either of any duration) or stable disease (SD) following study treatment initiation (by IRR)

Time from study treatment initiation to initial measurement of CR or PR, where CR or PR is subsequently confirmed

Number of months from study treatment initiation to the date of disease progression 3 or death due to any cause

Number of months from study treatment initiation to the date of death due to any cause or last follow up date if alive

Of treatment-emergent and treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Aadi Bioscience, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer	NCT00392769	Endometrial Can...	Cetuximab	-	M.D. Anderson Cancer Center
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)	NCT05001282	Ovarian Cancer Ovarian Neoplas... Ovarian Carcino... Endometrial Can... Ovary Cancer Ovary Neoplasm Ovary Disease Ovary Metastasi... Ovarian Disease... Ovarian Cancer ... Ovarian Epithel... Ovarian Adenoca... Ovarian Serous ... Ovarian Neoplas... Ovarian Cancer ... Endometrial Dis... Endometrial Ade... Endometrial Car... Endometrial Cle... Endometrioid Ad... Endometrial Neo... Endometrial Can... Endometrioid Tu... Fallopian Tube ... Peritoneal Canc...	ELU001	18 Years -	Elucida Oncology
Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer	NCT05997017	Endometrial Can... Endometrioid Tu... Cancer Tumor Recurrent Endom... Endometrioid En...	nab-sirolimus	18 Years -	Aadi Bioscience, Inc.

Spots Global Cancer Trial Database for endometrioid tumor