Colorectal cancer clinical trials, in English

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

NCT03998202 · Official ClinicalTrials.gov record · Wake Forest University Health Sciences

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.

NCT04557449 · Official ClinicalTrials.gov record · Pfizer

This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.

NCT04666727 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen.

NCT04847063 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This open-label, exploratory study is designed to measure the safety and how well it works of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

NCT04929223 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA.

NCT05112601 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

NCT05334069 · Official ClinicalTrials.gov record · Alliance for Clinical Trials in Oncology

This is an watch-and-measure (no experimental treatment required) case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid.

NCT05366881 · Official ClinicalTrials.gov record · Adela, Inc

To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.

NCT05411718 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.

NCT05492682 · Official ClinicalTrials.gov record · Valo Therapeutics Oy

This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.

NCT05845450 · Official ClinicalTrials.gov record · Gruppo Oncologico del Nord-Ovest

This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to measure the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as this drug alone and in combination with pembrolizumab (anti-PD-1 antibody).

NCT05856981 · Official ClinicalTrials.gov record · Sairopa B.V.

This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins.

NCT06102902 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC).

NCT06149481 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion.

NCT06242470 · Official ClinicalTrials.gov record · MacroGenics

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

NCT06252649 · Official ClinicalTrials.gov record · Amgen

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful.

NCT06324357 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This study is designed to assess the how well it works and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).

NCT06330064 · Official ClinicalTrials.gov record · Daiichi Sankyo

This study wants to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion).

NCT06400472 · Official ClinicalTrials.gov record · Eli Lilly and Company

The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.

NCT06529523 · Official ClinicalTrials.gov record · Memorial Sloan Kettering Cancer Center

To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.

NCT06645236 · Official ClinicalTrials.gov record · QIAGEN Gaithersburg, Inc

This study wants to measure the how well it works and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

NCT06695845 · Official ClinicalTrials.gov record · Jazz Pharmaceuticals

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

NCT06760819 · Official ClinicalTrials.gov record · Bayer

The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.

NCT06983743 · Official ClinicalTrials.gov record · Erasca, Inc.

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs.

NCT07007559 · Official ClinicalTrials.gov record · ALX Oncology Inc.

This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant). Surveillance care after resection of colorectal cancer is critical to detect potentially curable return of disease (recurrence), yet up to 60% of colorectal cancer survivors fail to receive surveillance.

NCT07018869 · Official ClinicalTrials.gov record · SWOG Cancer Research Network

This study will assess the safety and how well it works of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

NCT07020221 · Official ClinicalTrials.gov record · Verastem, Inc.

Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center watch-and-measure (no experimental treatment required) cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model.

NCT07144683 · Official ClinicalTrials.gov record · Minia University

A randomly assigned, Active-Controlled, neither you nor the study doctors know who gets the real treatment, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)

NCT07228832 · Official ClinicalTrials.gov record · Summit Therapeutics

This Phase 1b/2 trial will measure the safety and how well it works of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.

NCT07277322 · Official ClinicalTrials.gov record · Dan Feng

To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.

NCT07318389 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

This study wants to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.

NCT07318805 · Official ClinicalTrials.gov record · Pfizer

This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to measure the safety, PK, immunogenicity and preliminary how well it works of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

NCT07503808 · Official ClinicalTrials.gov record · IDEAYA Biosciences

This is a Phase 1/2 first-in-human, open-label multicenter study designed to measure the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors.

NCT07584226 · Official ClinicalTrials.gov record · Relay Therapeutics, Inc.

This study is to measure the whether it is safe and how hard side effects are to live with to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor how well it works (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.

NCT07636785 · Official ClinicalTrials.gov record · VM Discovery, Inc.

Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1).

NCT07719426 · Official ClinicalTrials.gov record · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

This Vietnam-based watch-and-measure (no experimental treatment required) study examines ecto-nucleotide pyrophosphatase/phosphodiesterase 1/cyclic GMP-AMP synthase (ENPP1/cGAS) protein and stromal fibroblast activation protein (FAP) expression in multiple solid tumor samples using immunohistochemistry (IHC). The study involves no investigational treatments or participant-facing procedures.

NCT07808164 · Official ClinicalTrials.gov record · Tam Anh Research Institute

The study investigates the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. Quantitative KLF4 methylation will be assessed in colorectal tissue samples obtained during routine colonoscopy, together with KLF4 gene expression and its correlation with methylation status in matched tissue samples.

NCT07901335 · Official ClinicalTrials.gov record · Azienda USL Reggio Emilia - IRCCS

This is a Phase 1/2, open-label, multi-center study to measure the safety, tolerability, PK, PD, and preliminary how well it works of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.

NCT07912593 · Official ClinicalTrials.gov record · Ensem Therapeutics

This study looks at the results of a new technique called knife-assisted full-thickness resection (kFTR) for removing rectal lesions. In kFTR, a doctor uses an electrical knife to remove a rectal growth along with the full thickness of the rectal wall.

NCT07923682 · Official ClinicalTrials.gov record · University Hospital, Ghent