Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Mitogens

Dose escalation of SYN125. Each dose level (low, medium, high) will be tested in a cohort of 3 patients. If no dose-limiting toxicity (DLT) is observed in the 3 patients, dose escalation will continue to the next SYN125 dose level.

Dose escalation of SYN125 administered with a fixed-dose of SYN004 (SYN004 will be administered immediately after SYN125 infusion is complete, if tolerated). Once cohorts with low and medium dose levels in Part A are completed and no DLTs are observed per cohort, Part B with the SYN125 low dose level + SYN004 will start and run in parallel with Part A. The high dose of SYN125 in a cohort in Part A will begin along with Part B.

SYN125

SYN004

Ding Wang, MD

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in the Treatment of Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Cancer of the Internal or External Lining of the Body.

Humans have an immune system that can protect and fight infections and abnormal cells. T-cells are a type of cell produced by the body that can attack and kill cancer cells. Unfortunately, many cancer cells have ways preventing T-cells from working properly. SYN125 and SYN004 can make T-cells work again. This is a study to find the maximum tolerated dose of SYN125 when it is used as a single treatment (Part A) for solid tumors, and when it is used as a combined treatment with a fixed dose of SYN004 (Part B), in patients with epithelial cancers with EGFR (epithelial growth factor receptor) expressions.

A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Epithelial Cancers With EGFR Expressions.

Incidence of DLTs with single agent SYN125

Incidence of DLTs with SYN125 and fixed-dose SYN004 administered in combination

Defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)

Serum concentration time profiles (Area under the serum concentration-time curve from time zero to the last measurable concentration) of SYN125 and SYN004

Area under the serum concentration time-curve over the dosing interval of SYN125 and SYN004

Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of SYN125 and SYN004

Maximum Observed Plasma Concentration (Cmax) of SYN125 and SYN004

Time to maximum observed serum concentration (Tmax) of SYN125 and SYN004

Terminal elimination half-life (t1/2) of SYN125 and SYN004

Volume of distribution at steady-state (Vss) of SYN125 and SYN004

Synermore Biologics USA Limited

Synermore Biologics Co., Ltd.

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Melanoma

Sarcoma

Neoplasm Metastasis

Neoplastic Processes

Soft Tissue Sarcoma

RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy:

For all sites the dose levels are as follows:

1. 8 Gy/ fraction x 3 fractions = 24 Gy
2. 10 Gy/fraction x 3 fractions = 30 Gy
3. 12 Gy/fraction x 3 fractions = 36 Gy
4. 14 Gy/fraction x 3 fractions = 42 Gy
5. 16 Gy/fraction x 3 fractions = 48 Gy
6. 18 Gy/fraction x 3 fractions = 52 Gy
7. 20 Gy/fraction x 3 fractions = 60 Gy

Hypofractionated RT

Steven Chmura, MD

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.

The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.

Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

The dose limiting toxicities occurring within the initial observation period will be defined.

University of Chicago

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

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

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Gastrointestinal Agents

Muromonab-CD3

Catumaxomab

Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).

catumaxomab

Michael V Seiden, MD, Ph.D

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.

Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy

Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.

Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die

Fresenius Biotech North America

Neovii Biotech

4 dose series (10-20-50-150 micrograms) within 21 days

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Anne Kuan

Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days

Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy

Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)

Number of Participants Who Survived (Post-study at 24 Month Visit)

Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.

Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Lung Neoplasms

Dermatologic Agents

Coal Tar

HLA genotyping and tumor tissue profiling for certain TAA and LOH.

Tumor and HLA Profiling

Marlyane Motta, BS

OncoBay Clinical CRO

Justin Moser, MD

Jialing Zhang

Michael Hurwitz, MD

Brian Pico, MD

Marialby Donis Ramos

Jose Lutzky, MD

Melinda Porter

Sajeve Thomas, MD

Ben Orem

Jaspreet Grewal, MD

Marie Ventimiglia

Ira Winer, MD

Manar Al-Assi

Elizabeth Shelton, MPH

Brian Henick, MD

UNC Immunotherapy Team

Jared Weiss, MD

Cancer Answer Line

James Isaacs, MD

Rom Leidner, MD

Shelly Evans

Yazan Samhouri, MD

Barb Stadterman

Jason Luke, MD

Dawn Pinchasik, MD

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, subjects will provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.

A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumors

To identify subjects with Head and Neck, Cervical, Ovarian, Melanoma, Non-Small Cell Lung HPV positive anogenital and other types of cancers that could potentially be eligible for the TScan Therapeutics clinical trials.

TScan Therapeutics, Inc.

Ear, Nose, and Throat Diseases

Laryngeal Diseases

Psychotropic Drugs

Anti-Infective Agents

Central Nervous System Stimulants

Cardiotonic Agents

Bupropion

Minocycline

Modafinil

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Anti-Bacterial Agents

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Placebo

Armodafinil

David I. Rosenthal, MD, MA, BA

The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.

The Study Drugs:

It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 3 study drugs that may help to reduce side effects such as fatigue, pain, sleep disturbance, difficulty swallowing, and lack of appetite. The study drugs will be tested alone and in combination with each other.

* Armodafinil is designed to prevent excessive sleepiness.
* Bupropion and minocycline each may reduce inflammation, which may help to reduce other symptoms. Bupropion is a drug for depression. Minocycline is an antibiotic (a drug to treat infection).

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 8 groups. You may be assigned to receive no study drugs, 1 study drug, a combination of 2, or all 3 of the study drugs.

During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. The study drugs are being tested to learn if they can help control symptoms. All participants will be able to receive standard care for head and neck cancer outside of the study.

Neither you nor the study staff will know if you are receiving the study drugs and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug(s) you are receiving.

Study Drug Administration:

You will take the study drugs/placebos 2 times every day for up to 10 weeks. You will take 1 or more study drug(s) or placebos by mouth each time, as instructed by the study doctor. If you have trouble swallowing the study drugs/placebos, they can be crushed just before taking them. You will be given information sheets on how to take the study drugs/placebos.

You will be given a daily diary to write down when you take the study drugs/placebos. You should bring your study drugs/placebos to the clinic to every study visit. You should also bring your diary to every study visit.

Symptom Questionnaire:

Throughout the study, you will be asked to fill out a symptom questionnaire. You will be asked about symptoms you may be experiencing and how they may be interfering with your daily activities. When you are in the clinic, the questionnaire can be completed by paper and pen with the study staff or by entering your answers into a computer. When you are away from the clinic, the questionnaire may be completed either through a phone call with the study staff or through a phone call from the interactive voice response (IVR) system. The symptom questionnaire will take up to 5 minutes each time. The study staff will give you the information you need to complete the questionnaire through the IVR system.

During Weeks 1-10, you will complete the symptom questionnaire 2 times a week. During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.

If you would like, you can fill out a paper version of the questionnaire instead of using the phone system.

Study Visits:

Before you begin chemoradiation:

* You will fill out 6 questionnaires about pain and other symptoms, your mood, your tobacco and alcohol use, and the quality of your life. This should take about 15 minutes.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.
* If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy. This will also be done at about Weeks 4 and 7, at the first follow-up visit after radiation treatment, and 30 days after the study drugs are stopped.

At about Week 4 of chemoradiation:

* You will fill out 1 quality-of-life questionnaire. This should take about 2-3 minutes.
* You will be asked three questions about smoking after the start of chemoradiation therapy.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.

During the last week of chemoradiation (about Week 7):

-You will fill out 3 questionnaires about your symptoms, mood, and quality of life. This should take about 10 minutes.

After about Week 7, the study staff will call you 2 times per week to check on you until Week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call may take longer.

At about Week 10 and at your first follow-up visit after your chemoradiation treatment:

* You will fill out 3 questionnaires about your symptoms, mood, and quality of life.
* You will fill out 2 questionnaires that ask about your smoking history and changes in your tobacco use during the study. This will take a few minutes.
* You will be asked to fill out another questionnaire that asks about your satisfaction with the study drug(s). For example, you will be asked if you thought the study drugs helped to control the symptoms, if you would recommend the study drugs to other patients, and if you had problems taking the study drugs. This will take a few minutes.
* In addition, at your first follow-up visit after your chemoradiation treatment, you will have a blood coagulation test, called PT INR, to make sure your blood clots normally.

Length of Study:

You will take the study drug(s)/placebo for up to 10 weeks, if the doctor thinks it is in your best interest. You will fill out the symptom questionnaires by phone until 16 weeks. You will no longer be able to take the study drug(s)/placebo if you experience intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The different possible combinations of these drugs being used in this study are investigational.

Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.

Symptom Burden in Head and Neck Cancer

A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer

Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Placebo by mouth 2 times every day.

Placebo: 1 by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion 100 mg by mouth two times a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Armodafinil + Minocycline

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Bupropion

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Minocycline + Bupropion

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Minocycline + Bupropion

Total

<=18 years

Between 18 and 65 years

>=65 years

Female

Male

Gender

Study halted due to low enrollment (one participant). No analysis completed.

Analysis was not possible due to early termination with only one participant accrued.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions	NCT04363242	Epithelial Carc... Solid Tumor	SYN125 SYN004	18 Years -	Synermore Biologics Co., Ltd.
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer	NCT01215500	Tumor Cancer Melanoma Sarcoma Carcinoma	Hypofractionate...	18 Years -	University of Chicago
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy	NCT00377429	Ovarian Cancer	catumaxomab	18 Years -	Neovii Biotech
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors	NCT05812027	Head and Neck C... Cervical Cancer Non Small Cell ... Melanoma Ovarian Cancer HPV16 Related C...	Tumor and HLA P...	18 Years -	TScan Therapeutics, Inc.
Symptom Burden in Head and Neck Cancer	NCT01219673	Head And Neck C...	Placebo Armodafinil Minocycline Bupropion	18 Years - 65 Years	M.D. Anderson Cancer Center
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites	NCT00326885	Malignant Ascit...	catumaxomab	18 Years -	Neovii Biotech
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors	NCT05812027	Head and Neck C... Cervical Cancer Non Small Cell ... Melanoma Ovarian Cancer HPV16 Related C...	Tumor and HLA P...	18 Years -	TScan Therapeutics, Inc.
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy	NCT00377429	Ovarian Cancer	catumaxomab	18 Years -	Neovii Biotech

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