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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Miscellaneous

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:

* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Miscellaneous
I/II
Cardin, Dana
NCT04657068
VICCGIP25035

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Breast

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Breast
III
Abramson, Vandana
NCT07085767
VICCBRE25043

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Lung

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Lung
II
Ramirez, Robert
NCT04665739
SWOGTHOA021901

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
Prostate
II
Schaffer, Kerry
NCT06842498
VICCURO24538

DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)

Neuro-Oncology

The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone.

Participants in the DOC1021 + pIFN + SOC arm will:

* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection
* Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses
* Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections

Both arms of the trial will:

\- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
Neuro-Oncology
II
Merrell, Ryan
NCT06805305
VICCNEU24587

Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Multiple Cancer Types

This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).
Leukemia, Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT07216443
VICCCTT25025

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

Lymphoma

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).

The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.

The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* How the study drug affects quality of life and ability to complete routine daily activities.
Lymphoma
III
Bhaskar, Shakthi
NCT06091254
VICC-DTPCL23483

Enhanced Recovery After Surgery in Extremity Sarcoma

Sarcoma

The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.
Sarcoma
N/A
Lawrenz, Joshua
NCT04461171
VICCSAR2020

A Study of ASP3082 in Adults With Advanced Solid Tumors

This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D.

This study will be in 2 parts.

In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.

In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments.

Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
Not Available
I
Not Available
NCT05382559
VICCPHI2207

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Multiple Cancer Types

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
Bladder, Kidney (Renal Cell), Rectal
II
Schaffer, Kerry
NCT03866382
ALLIANCEUROA031702

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