Clinical Trials for Rectal Cancer

Phase II Trial of Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With 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.

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.

HealthScout AI summary: This trial enrolls adults with left-sided, unresectable, metastatic, mismatch repair–proficient colorectal cancer without KRAS, NRAS, or BRAF V600 mutations to study panitumumab or cetuximab, alone or with chemotherapy, as early-line therapy, retreatment, or rechallenge based on prior anti-EGFR and chemotherapy exposure. Patients are assigned to cohorts according to their prior response and exposure to EGFR inhibitors and FOLFOX.

ClinicalTrials.gov ID: NCT04587128

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

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.

HealthScout AI summary: Adults with advanced or metastatic, microsatellite stable colorectal cancer harboring a KRAS G12C mutation who have progressed on at least one prior line of chemotherapy are eligible for combination therapy with adagrasib (a selective KRAS G12C inhibitor), cetuximab (anti-EGFR antibody), and cemiplimab (PD-1 inhibitor). Prior exposure to KRAS G12C or immune checkpoint inhibitors is excluded.

ClinicalTrials.gov ID: NCT06412198

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease

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.

HealthScout AI summary: Adults with refractory metastatic colorectal cancer and liver-dominant disease (≤50% liver involvement; limited extrahepatic disease allowed; ECOG 0–1) are randomized to induction hepatic-directed high-dose melphalan via the Delcath system (regional chemotherapy that isolates hepatic circulation to intensify cytotoxic exposure) followed by trifluridine–tipiracil plus bevacizumab, versus trifluridine–tipiracil plus bevacizumab alone. Prior exposure to fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and anti-EGFR (if RAS WT) is required; key exclusions include significant hepatic dysfunction, portal/venous thrombosis, major cardiopulmonary comorbidity, prior arterial liver-directed therapy, and peritoneal disease.

ClinicalTrials.gov ID: NCT06607458

A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy

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.

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.

HealthScout AI summary: Adults with peritoneal carcinomatosis from colorectal or appendiceal primaries undergoing cytoreductive surgery are randomized to HIPEC mitomycin C given as a fixed total dose (40 mg) versus weight-based dosing (12.5 mg/m2). Both arms use mitomycin C, a DNA crosslinking cytotoxic antibiotic, with the study focused on pharmacokinetics and potential reduction of systemic exposure/toxicity.

ClinicalTrials.gov ID: NCT04779554

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial involves patients with locally advanced or metastatic pancreatic, lung, breast, and colorectal cancers who have progressed after standard treatments and exhibit tumor uptake of [68Ga]Ga-NNS309. It evaluates the safety and preliminary activity of the investigational radioligand [177Lu]Lu-NNS309, which targets specific tumor markers, though its exact mechanism of action is undisclosed.

ClinicalTrials.gov ID: NCT06562192

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

ClinicalTrials.gov ID: NCT06362369

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 Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial involves adult patients with advanced solid tumors, including specific types like hepatocellular carcinoma and non-small cell lung cancer, who have exhausted standard treatments, and assesses the safety and clinical activity of Decoy20, a Toll-like receptor agonist immunotherapy, both alone and in combination with the PD-1 inhibitor tislelizumab.

ClinicalTrials.gov ID: NCT05651022

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial enrolls patients aged 18 and older with advanced solid tumors, including RCC, CRPC, NSCLC, SCCHN, CRC, endometrial, and ovarian cancers, who have failed or are ineligible for standard treatments, to evaluate TT-10, an adenosine A2A receptor antagonist, and TT-4, an adenosine A2B receptor antagonist, administered as single agents and in combination.

ClinicalTrials.gov ID: NCT04969315

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial investigates the safety and anti-tumor activity of the investigational drug BMS-986488, alone or combined with adagrasib, cetuximab, or nivolumab, in adults with advanced malignant tumors, including specific cohorts with ccRCC, NSCLC (KRAS G12C mutation), ccOC, and CRC (KRAS G12C mutation).

ClinicalTrials.gov ID: NCT06764771

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial enrolls adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express EGFR and have lost HLA-A*02 expression, including types such as CRC, NSCLC, HNSCC, TNBC, and RCC, and tests A2B395, a logic-gated Tmod™ CAR T-cell therapy designed to selectively target these tumor cells while sparing healthy cells. Participants receive a preconditioning lymphodepletion regimen followed by a single intravenous dose of A2B395.

ClinicalTrials.gov ID: NCT06682793