Clinical Research Directory

SMYD3-Driven Metabolic Rewiring in Colorectal Liver Metastases

This study focuses on patients with colorectal cancer undergoing surgery for the primary tumor and/or liver metastases. Tumor samples collected during surgery will be used to generate patient-derived models (primary cultures, spheroids, and organoids) to study colorectal cancer stem cells. The main objective is to investigate the role of the lysine methyltransferase SMYD3 in metabolic reprogramming and adaptation to oxidative stress that enable colorectal cancer cells to survive and grow in the liver. Previous work has shown that SMYD3 is overexpressed in colorectal cancer, promotes drug resistance, and regulates key oncogenic pathways, including c-MYC and the AMPK/mTOR axis. By identifying SMYD3-dependent pathways and pharmacologic vulnerabilities in cancer stem cells within liver metastases, this study aims to support the development of new therapeutic strategies that combine SMYD3 inhibitors with approved or experimental agents targeting tumor metabolism and oxidative stress responses

A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.

A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC. Participants will take: Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Validation of High-Throughput Large-Format Tissue Preprocessing for Lung and Colorectal Cancer

This project aims to employ a sample preprocessing system in conjunction with three-dimensional imaging techniques to generate morphologically more complete, high-resolution datasets for lung and colorectal cancers. Building on systematic experimental optimization of the preprocessing system, the investigators will establish tissue-clearing workflows and transparency assessment criteria specifically for lung and colorectal cancer specimens, and develop and validate an efficient 3D immunofluorescent iterative staining protocol adapted for these tumor types to achieve robust three-dimensional imaging. Successful implementation of this project will enable an in-depth characterization of the spatial morphological features of lung and colorectal cancer pathology, facilitate identification of more effective and precise interventional strategies, and ultimately contribute to improved overall survival for cancer patients. Additionally, the resulting datasets will support prospective validation of two-dimensional pathological models.

Feasibility of a Multi-Channel Intervention to Promote Colorectal Cancer Screening Among American Indians in Oklahoma

The Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS) Program addresses major regional CRC screening disparities among AI in Oklahoma. The investigators are engaged in a participatory and collaborative effort with Tribal Nations, Area Indian Health Boards, and Indian Health Service (IHS) healthcare facilities. The overall objective of this proposal is to leverage these relationships and examine the feasibility of co-developing and disseminating a v-TCHE as part of a multi-channel communication intervention. To achieve this objective, the investigators have partnered with IHS Clinton Service Unit, which serves members of the Cheyenne and Arapaho Tribes. The intervention will be disseminated across two channels: (1) Social Media (i.e., accessed via online study adverts) and (2) Clinic (i.e., direct messaging to patients via a study link in a SMS text). Across both channels, the investigators will examine reach of the intervention and its potential efficacy via a randomized controlled trial. Once participants click on the study link they will be randomized 1:1 to one of two intervention conditions: (1) watch a Narrative Testimonial Video of a real-life Tribal community health educator (control) or (2) an interaction with a v-TCHE. Participants will then complete a post-intervention survey, in which they can click to order a FIT kit afterwards.

A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer

For colorectal cancer with peritoneal metastasis, the current first-line standard treatment offers very limited benefits and short survival. Therefore, it is necessary to seek new treatment strategies to improve the prognosis and survival of such patients. Based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or RTX provides a feasible solution that can benefit patients with advanced colorectal cancer and peritoneal metastasis undergoing first-line treatment. This study aims to evaluate the effectiveness of PIPAC combined with MMC or RTX as first-line treatment for patients with colorectal cancer and peritoneal metastasis, while ensuring that patients receive standard first-line treatment. (The main purpose of the proposed Phase I trial is to determine the MTD of PIPAC combined with MMC or RTX and evaluate the safety of combining it with systemic chemotherapy for patients with colorectal cancer and peritoneal metastasis.)

Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer

This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.

Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer

The study in question is an observational study that aims to identify new non-invasive biomarkers present in the serum of patients with CRC and, subsequently, to create a score capable of predicting the development of CRC. It is an observational study with 3 enrollment arms: Arm 1: Patients undergoing surgery at the U.O.C. of Surgery, with a CRC diagnosis; Arm 2: Subjects with a negative result from the endoscopic examination; Arm 3: Subjects in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.

A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.

cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer

The EpiCORE study aims to identify cfDNA-based epigenetic markers predictive of response to first-line chemotherapy (FOLFOX or FOLFIRI) in metastatic colorectal cancer (mCRC). By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to establish a non-invasive biomarker panel capable of distinguishing responders from non-responders.

Development of a cfDNA 5mC/5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC

The EpiDRIVE study aims to identify cfDNA-based epigenetic determinants of response in metastatic colorectal cancer (mCRC) patients treated with EGFR- or VEGF-targeted therapy. By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to develop a predictive biomarker panel capable of differentiating responders from non-responders to targeted therapy.

Improving Rates of Diagnostic Colonoscopy in Native Americans

Colorectal cancer (CRC) is the second-leading cause of cancer death in both men and women in the United States. Compared to national averages, Native Americans (NA) endure a disproportionate burden of CRC incidence and CRC-specific mortality. The long-term goal of this collaboration is to enhance health equity through the reduction of CRC disparities in morbidity, mortality, stage-at-diagnosis, and survival among NA. To do so, the primary focus of these efforts has been to improve processes that increase uptake of home stool screening. The overall objective is to leverage these relationships and infrastructure to now focus on improving rates of timely diagnostic colonoscopy follow up after an abnormal home stool screening.

A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors

This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations. The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276. The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.

PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal cancer.

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

The goal of this exploration study is to evaluate the performance of a colorectal cancer (CRC) early screening model based on the DNA methylation technology platform. The study focuses on individuals over the age of 40 and aims to identify and verify methylation biomarkers for colorectal cancer using stool samples . The main question it aims to answer is: Can a DNA methylation-based model effectively detect colorectal cancer and adenoma in individuals over 40 using non-invasive stool samples? Participants will provide stool samples for methylation analysis. The study results will be used solely for internal product performance evaluation and optimization by the sponsor and will not be used for product registration or influence any clinical diagnosis.

A Study of DCTY1102 Injection in Patients With Advanced Solid Tumors

This study is an open-label, single-arm, multicenter Phase I clinical trial consisting of a dose-escalation phase (Phase Ia) and a cohort-expansion phase (Phase Ib). Phase Ia (Dose Escalation) aims to evaluate the safety and tolerability of DCTY1102 Injection in patients with advanced solid tumors positive for KRAS G12D mutation and HLA-A\*11:01 genotype, observe potential dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), characterize the pharmacokinetic (PK) profile of DCTY1102 following infusion, assess its in vivo proliferation and persistence, preliminarily evaluate therapeutic efficacy, and investigate immunogenicity. Phase Ib (Cohort Expansion) will be conducted after establishing MTD and/or RP2D in Phase Ia. This phase further evaluates the preliminary efficacy, safety, PK profile, and immunogenicity of DCTY1102 Injection in patients with KRAS G12D mutation-positive, HLA-A\*11:01 genotype tumors, including colorectal cancer, pancreatic cancer, or other malignancies. The study plans to establish 2-3 cohorts: Cohort 1: Colorectal cancer Cohort 2: Pancreatic cancer Cohort 3: Other tumor types Each cohort will enroll approximately 15-31 patients who will receive DCTY1102 infusion at the MTD and/or RP2D dose levels identified in Phase Ia.

Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer

This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (WD-01) in the metastatic colorectal cancer.