Clinical Trials for Colon Cancer

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with EGFR‑dependent advanced solid tumors—primarily mCRC (RAS/RAF WT, MSS; anti‑EGFR–naive for chemo combos or 3L+ without HER2 amp/oncogenic EGFR ECD mutations) and previously included HNSCC—receive petosemtamab, a bispecific anti‑EGFR/LGR5 IgG1 antibody given Q2W as monotherapy or combined with FOLFOX/FOLFIRI (and previously pembrolizumab in HNSCC). Suitable for ECOG 0–1 patients without uncontrolled CNS disease; aims to exploit EGFR blockade and LGR5‑targeted EGFR degradation with Fc effector function.

ClinicalTrials.gov ID: NCT03526835

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors, including biomarker-selected cohorts (e.g., ATM loss/alterations; platinum‑resistant high‑grade serous ovarian cancer; selected endometrial, colorectal, and pancreatic cancers), after appropriate standard therapies. Investigational therapy is ART0380, an oral ATR kinase inhibitor exploiting replication-stress/synthetic lethality, given as monotherapy or combined with gemcitabine or irinotecan; includes a randomized cohort of platinum‑resistant ovarian cancer comparing ART0380+gemcitabine versus gemcitabine.

ClinicalTrials.gov ID: NCT04657068

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic or locally advanced/inoperable GI cancers (colorectal and non-colorectal; ECOG 0–1; excluding dMMR/MSI-H, known DPD deficiency, and prior oxaliplatin/fluoropyrimidine) receive an oxaliplatin/leucovorin backbone with infusional 5-FU, using an adaptive algorithm to escalate 5-FU from 2,400 to up to 3,200 mg/m2 over early cycles based on tolerance. Investigational aspect is individualized 5-FU dose escalation within a FOLFOX-like regimen to optimize dose intensity and assess response, PFS, and PK correlations.

ClinicalTrials.gov ID: NCT05780684

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic GI adenocarcinomas (colorectal, pancreaticobiliary, or upper GI) progressing after standard therapy receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus capecitabine in 21-day cycles; prior topo I inhibitor exposure is excluded, treated/stable brain mets allowed. Dose-escalation assesses safety/tolerability and seeks an RP2D, with exploratory correlation to tumor Trop-2 expression.

ClinicalTrials.gov ID: NCT06065371

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

A Phase 1b/2 Study of AVUTOMETINIB and Cetuximab in Participants With Advanced KRAS Mutated Colorectal Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic KRAS-mutant colorectal adenocarcinoma after failure/intolerance of standard 5-FU/capecitabine, oxaliplatin, irinotecan, and anti-VEGF therapy (and prior IO for MSI-H) receive avutometinib (a dual RAF/MEK inhibitor that stabilizes inactive RAF–MEK complexes) plus cetuximab. Excludes prior MEK/EGFR/KRAS/SOS1/SHP2 inhibitors and those with significant cardiovascular/ocular risks or unstable CNS metastases.

ClinicalTrials.gov ID: NCT05200442

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolling adults with ECOG 0–1, measurable, mismatch repair–proficient/microsatellite-stable advanced/metastatic colorectal adenocarcinoma that has progressed on or is intolerant to standard metastatic CRC therapies (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR for RAS wild-type), excluding MSI-H/dMMR, BRAF V600, and prior regorafenib/TAS-102/fruquintinib. Patients are randomized to fruquintinib (oral selective VEGFR-1/2/3 TKI anti-angiogenic) plus TAS-102 (trifluridine/tipiracil DNA-directed cytotoxic) versus fruquintinib alone.

ClinicalTrials.gov ID: NCT06992258

Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with locally advanced unresectable or metastatic colorectal cancer (RECIST-measurable, ECOG 0–1) who have not received prior systemic therapy for advanced disease (including recurrent disease after resection without prior systemic therapy). Patients receive first-line FOLFIRI or mFOLFOX6 combined with fruquintinib, an oral selective VEGFR-1/2/3 tyrosine kinase inhibitor (anti-angiogenic) dosed days 1–21 of a 28-day cycle, with maintenance 5-FU plus fruquintinib after ~6 months in those with at least stable disease.

ClinicalTrials.gov ID: NCT07042685

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with relapsed/refractory metastatic colorectal cancer that is GCC (GUCY2C)–positive by IHC, previously treated with fluoropyrimidine/oxaliplatin/irinotecan and appropriate biologics (anti-VEGF and anti-EGFR if RAS WT), with measurable extracranial disease and limited liver tumor burden (<7 lesions, largest <3 cm) and no curative surgical option. Patients undergo leukapheresis and receive a single infusion of autologous GCC19CART (LYL273), a GCC-targeted CAR T-cell therapy using a coupled GCC CAR plus CD19 CAR component intended to enhance activation/expansion in solid tumors.

ClinicalTrials.gov ID: NCT05319314

Evaluation of Circulating Immune Response After Histosonics in Colorectal Cancer (ECHO-CRC)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolling adults with biopsy-confirmed metastatic microsatellite-stable colorectal cancer and at least one radiographically evident liver metastasis who are planned for standard-of-care histotripsy (ECOG 0–3, adequate organ function). Patients receive noninvasive focused ultrasound histotripsy (mechanical tumor disruption via acoustic cavitation) to one or more liver metastases with serial blood draws pre/post procedure to assess systemic immune modulation (T-cell clonal expansion and exhaustion markers).

ClinicalTrials.gov ID: NCT07361107