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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

This trial will be a randomized controlled study comparing the efficacy and safety of
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care.
Not Available
III
Chambless, Lola
NCT04365374
VICC-DTNEU23344

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Nave

This study will evaluate the safety and efficacy of intravesical administration of EG-70 in
the bladder and its effect on bladder tumors in patients with NMIBC.

This study study consists of two phases; a Phase 1 dose-escalation to establish safety and
recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the
treatment is.

The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and
patients with NMIBC with Cis who are BCG-nave or inadequately treated.
Not Available
I/II
Chang, Sam
NCT04752722
VICC-DDURO24102P

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is
typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can
cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are
available, but MM can come back (relapsed) or may not get better (refractory) with treatment.
This is a study to determine adverse events and change in disease symptoms of ABBV-383 in
adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma
(MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2
parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different
level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the
step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of
ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with
relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the
world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for
approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and questionnaires.
Not Available
I
Not Available
NCT05650632
VICC-DTPCL23010P

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). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Lung
II
Ramirez, Robert
NCT04665739
SWOGTHOA021901

TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage I-III Breast Cancer in Patients with Residual Disease after Chemotherapy and Surgery

This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage I-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage I-III breast cancer.
Not Available
II
Not Available
NCT04197687
VICCBRE2241

Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers

This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.
Not Available
I
Heumann, Thatcher
NCT05803382
VICC-NTPHI23420

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose
(RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with
investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable,
advanced, well-differentiated, somatostatin receptor expressing (SSTR+)
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following
treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as
177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
Not Available
I/III
Not Available
NCT05477576
VICCGIP2209

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound
that targets both EGFR with TGF. Based on preclinical data, this bifunctional antibody may
exert synergistic activity in patients with EGFR-driven tumors.
Not Available
I
Choe, Jennifer
NCT04429542
VICCPHI2254

Testing the use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.
Not Available
II
Choe, Jennifer
NCT05638295
ECOGMDEAY191-E5

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109,
which is a recombinant humanized tetravalent antibody targeting the human death receptor 5
(DR5).
Not Available
I
Davis, Elizabeth
NCT03715933
VICCMDP2287

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