Office of Research
Clinical Trials

Testing Abemaciclib with 5-Fluorouracil for Metastatic Colorectal Cancer

This clinical trial is investigating how well two drugs, Abemaciclib and 5-Fluorouracil (5-FU), work together in treating people with colorectal cancer that has spread to other parts of the body and hasn't responded to other treatments. The study aims to discover the safest dose of the drug combination that patients can handle without severe side effects. Participants will take Abemaciclib by mouth twice daily, and receive 5-FU through a vein on specific days during each 28-day cycle. Throughout the study, various samples will be collected to track the effectiveness and side effects of the treatment. After finishing the treatment cycles, participants will be monitored every three months for follow-up. Researchers hope this combination will provide a new option for those with this difficult-to-treat cancer type.

This study may be appropriate for those with: Metastatic Cancer

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

The main purpose of this study is to measure the safety and effectiveness with ivonescimab/SMT112 in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and Fluorouracil) in the first-line treatment of metastatic colorectal cancer (mCRC) compared to bevacizumab in combination with chemotherapy drugs, i.e., FOLFOX (Oxaliplatin, Leucovorin and 5-Fluorouracil). Ivonescimab/SMT112 is considered investigational and has not been approved by the U.S. Food & Drug Administration/local Regulatory Authority for treatment or sale. Bevacizumab is a different approved drug sold under the brand name Avastin. FOLFOX is a standard chemotherapy regimen made up of the drugs folinic acid (leucovorin, FOL), fluorouracil (5-FU, F), and oxaliplatin (Eloxatin, OX).

This study may be appropriate for those with: Metastatic Cancer

Study of RAS Inhibitors in GI Tumors

This clinical study is investigating new drugs called RAS inhibitors for treating gastrointestinal cancers, focusing mainly on colorectal and pancreatic cancers. The goal is to see if these drugs are safe, how well they are tolerated by patients, and if they show any early signs of fighting the cancer. Researchers are combining these RAS inhibitors with standard cancer treatments or other new drugs to find the most effective therapy. The study has three main parts, each testing a different combination of drugs: 1. **Part A**: This part looks at RMC-6236 combined with 5-fluorouracil-based treatments in patients who have not received prior treatment for their unresectable or metastatic colorectal cancer or metastatic pancreatic cancer. 2. **Part B**: In this segment, RMC-6236 is paired with cetuximab, and sometimes with mFOLFOX6, for patients with unresectable or metastatic colorectal cancer or those who have either previously treated or newly diagnosed metastatic pancreatic cancer. 3. **Part C**: This section tests RMC-6236 combined with gemcitabine and nab-paclitaxel in patients who have newly diagnosed metastatic pancreatic cancer. Each part of the study is open-label, meaning that both the doctors and the patients know which treatments are being given. The study consists of two phases: Dose Exploration to find the right dose levels and Dose Expansion to further evaluate the selected doses. To join the study, participants must be adults with specific types of cancer and good overall health. They should not have had major surgery 28 days before starting the study, and cannot have certain health issues like primary CNS tumors or GI problems that might affect the drug's absorption. The main outcomes of the study include monitoring for adverse events, understanding how the drug moves through the body, and measuring how well the drug works against the cancer. These measurements will include looking at how long and how well patients respond to the treatment, how long they live without the cancer getting worse, and their overall survival time. The study is currently recruiting participants and holds promise for finding more effective treatments for GI cancers involving mutations in the RAS gene.

This study may be appropriate for those with: Metastatic Cancer

Calderasib With Chemo For KRAS G12C

This is a Phase 3, randomized study for people with advanced colorectal cancer that cannot be removed by surgery or has spread, and whose tumor has the KRAS G12C mutation. The study tests whether adding the targeted drug calderasib (MK-1084) plus cetuximab to a standard chemotherapy regimen called mFOLFOX6 works better than mFOLFOX6 with or without bevacizumab. The study has two parts and will look at safety and how well people tolerate treatment, plus whether the new combination delays cancer growth and helps people live longer. People may join if their cancer tests positive for KRAS G12C and they meet other health rules (some people with controlled HIV or viral hepatitis may be eligible). Certain health problems, recent treatments, or other active cancers can keep someone from joining. Participants receive study treatments and have regular visits for safety checks, scans, and quality-of-life questionnaires over months to years of follow-up.

This study may be appropriate for those with: Metastatic Cancer

Family Genetic Communication Study

This study tests two ways of letting close family members know about inherited genetic changes found in people newly diagnosed with colorectal cancer. First, patients (called probands) get blood testing for inherited cancer genes. If a harmful inherited change is found, the patient and their eligible first-degree relatives are put into one of two groups. In the usual approach, the patient tells relatives about the test result (proband-mediated). In the other approach, a healthcare team member contacts relatives directly to offer testing and information (provider-mediated). The main goal is to see which method leads to more relatives getting genetic testing within 6 months. The study also looks at whether relatives who test positive take prevention steps within a year, whether testing differs by patient subgroups (such as age, race, or rural vs. urban), the range of inherited variants found, and patient disease-free survival over 3 years. Probands are followed up for up to 3 years; relatives are followed for up to 1 year. Materials and counseling are provided in English or Spanish.

DISP 10 Advanced GI Cancer Study

This is an early phase (Phase 1) study testing DISP 10, a combination of an engineered adenovirus (DV-10) and a CAR T cell therapy (idecabtagene vicleucel or ide‑cel). Adults with advanced or metastatic cancers of the esophagus, gastroesophageal junction, stomach, or colon who have measurable disease and at least one site for biopsy may join. The study has two parts: Part 1 slowly increases doses to find a recommended dose for expansion, focusing on safety and dose‑limiting toxicities. Part 2 treats more participants at that dose to learn about safety and whether tumors shrink or stabilize. Main goals are to record side effects, establish a safe dose, and measure tumor response. Participants must have good organ function and no major infections, recent transplants, or prior similar viral or CAR T therapies. Follow up includes frequent checks after treatment and ongoing monitoring for up to 2 years, with long term survival follow up possible up to 15 years.

This study may be appropriate for those with: Metastatic Cancer

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/​11 Mutations or PRKC Fusions

This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.

This study may be appropriate for those with: Metastatic Cancer

Testing a New Treatment Combination for Advanced Colon or Rectal Cancer

his research study is testing whether adding a medicine called pelareorep to standard treatment can help people with advanced colon or rectal cancer that has spread to other parts of the body. The study is for adults whose cancer has a RAS gene mutation, is microsatellite stable, and has worsened after a previous oxaliplatin-based treatment. Participants will be assigned by chance to receive either standard treatment with chemotherapy and bevacizumab or the same treatment plus pelareorep. Study doctors will monitor tumor response, side effects, and overall health through clinic visits, blood and urine tests, physical exams, and regular imaging scans. The information collected may help determine whether this treatment combination improves outcomes for patients with this type of colorectal cancer.

This study may be appropriate for those with: Metastatic Cancer

BBO 11818 in KRAS Mutant Cancer

This is an early stage (Phase 1a/1b) open study testing a new oral drug called BBO 11818, which targets KRAS mutations found in many solid tumors. The study will enroll adults with advanced unresectable or metastatic cancers that carry specific KRAS mutations (G12A, G12C, G12D, G12S, or G12V), including lung, colorectal, and pancreatic cancers. The main goals are to find safe dose levels, watch for side effects, measure how the drug behaves in the body, and get a first look at whether the drug can shrink tumors or slow their growth. The study includes a dose-finding stage and a later expansion stage. BBO 11818 will be tested alone and with other approved cancer treatments such as pembrolizumab (an immune therapy), various chemotherapy combinations, and cetuximab. Participants will be seen regularly for tests, scans, and safety checks and followed over time to record responses and any side effects.

This study may be appropriate for those with: Metastatic Cancer