Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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.

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.

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.

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.

The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:

1. what is the maximum tolerated dose and recommended dose for phase 2?

2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?

This study is being done to find out if tucatinib with other cancer drugs works better than
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side
effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body
(metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The
tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group
will get either:

- mFOLFOX6 alone,

- mFOLFOX6 with bevacizumab, or

- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs
given in this study are used to treat this type of cancer.

The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).

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.

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.

This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and
anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid
tumor malignancy with homozygous deletion of the MTAP gene.