Clinical Trials for Rectal Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

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.

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.

TrialFetch AI summary: Eligible patients are adults with metastatic, refractory gastrointestinal, hepatobiliary, genitourinary, breast, ovarian, endometrial, or selected endocrine/neuroendocrine tumors who have failed standard therapies and have a resectable lesion for TIL generation. Treatment includes lymphodepleting chemotherapy, autologous tumor-infiltrating lymphocyte (TIL) infusion, high-dose aldesleukin, and pembrolizumab, a PD-1 immune checkpoint inhibitor, with timing of pembrolizumab varying by study arm.

ClinicalTrials.gov ID: NCT01174121

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

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.

TrialFetch AI summary: This trial enrolls adults with advanced, unresectable, or metastatic solid tumors (excluding primary CNS tumors) who have progressed on or are intolerant to standard therapies, with preferential inclusion of BRCA2 loss-of-function cases. Patients receive ETX-19477, a novel reversible small molecule inhibitor of poly(ADP-ribose) glycohydrolase (PARG), given as monotherapy.

ClinicalTrials.gov ID: NCT06395519

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic 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.

TrialFetch AI summary: Eligible patients are adults with unresectable, locally advanced, or metastatic solid tumors who have exhausted standard therapies, good performance status (ECOG 0-1), and adequate organ function. The investigational agent is AGX101, a TM4SF1-targeted antibody-drug conjugate delivering a maytansinoid payload to tumor and tumor vasculature cells.

ClinicalTrials.gov ID: NCT06440005

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, 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.

TrialFetch AI summary: Eligible patients are adults with advanced, refractory solid tumors of any histology (including those with stable, treated CNS metastases) and good performance status. The trial evaluates LCB84, a TROP2-targeted antibody-drug conjugate delivering MMAE, given alone or in combination with an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05941507

A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 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.

TrialFetch AI summary: Adults with advanced, measurable solid tumors and assessable MUC1 and/or HER3 expression are eligible to receive DM002, a bispecific antibody-drug conjugate targeting MUC1 and HER3, given intravenously every three weeks.

ClinicalTrials.gov ID: NCT06751329

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

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.

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.

TrialFetch AI summary: This trial enrolls adults with peritoneal carcinomatosis from ovarian, uterine, gastric, appendiceal, or colorectal cancer who have progressed after at least one prior chemotherapy, testing the safety and efficacy of PIPAC (pressurized intraperitoneal aerosol chemotherapy) with standard agents (doxorubicin/cisplatin, oxaliplatin, or mitomycin plus FOLFIRI) according to tumor type and prior treatment. PIPAC aims to enhance local drug exposure in the peritoneum while potentially reducing systemic toxicity.

ClinicalTrials.gov ID: NCT04329494

A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

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.

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.

TrialFetch AI summary: This trial enrolls adults with unresectable or metastatic colorectal adenocarcinoma lacking RAS, RAF, EGFR, and ERBB2 alterations, and evaluates the bispecific EGFR/MET antibody amivantamab (which blocks both receptors and recruits immune effector cells) as monotherapy or in combination with standard mFOLFOX6 or FOLFIRI chemotherapy. Patients with symptomatic CNS disease are excluded.

ClinicalTrials.gov ID: NCT05379595

A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and/or Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049

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.

TrialFetch AI summary: This trial enrolls adults with advanced, unresectable, or metastatic colorectal carcinoma (in Europe and US), as well as gastric carcinoma or pancreatic ductal adenocarcinoma (in the US), who have progressed after standard therapies or are ineligible for them, to receive BI 765049, a bispecific T-cell engager targeting B7-H6 on tumor cells and CD3 on T cells. The study investigates different dosing regimens of parenteral BI 765049, with treatment continuing in the absence of progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT06882746

A Phase I Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer

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.

TrialFetch AI summary: Adults with unresectable metastatic colorectal adenocarcinoma who have progressed after at least two prior lines of therapy and have ECOG 0-1 are eligible to receive investigational JNJ-89402638 (mechanism of action not disclosed); the study uses dose escalation and expansion to assess safety and determine the recommended phase 2 dose.

ClinicalTrials.gov ID: NCT06663319

A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers

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.

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.

TrialFetch AI summary: Eligible patients have advanced or metastatic colorectal or gastroesophageal adenocarcinoma with prior treatment failure, and will receive oral trifluridine/tipiracil plus talazoparib, a PARP inhibitor targeting DNA repair, to evaluate safety and dosing. Certain biomarker-defined cohorts are also included.

ClinicalTrials.gov ID: NCT04511039