Clinical Trials for Rectal Cancer

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic solid tumors—including colorectal, triple-negative breast, melanoma, and ovarian cancer—who have progressed on or cannot receive standard therapies, to receive NM1F (a PVRIG/CD112R immune checkpoint inhibitor) alone or in combination with pembrolizumab. Key exclusions are active CNS involvement, prior PVRIG/CD226-axis therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT05746897

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.

HealthScout 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

An Open-label, Multi-center Phase I/Ib Dose Finding and Expansion Study of HRO761 as Single Agent and in Combinations in Patients With Microsatellite Instability-High or Mismatch Repair Deficient 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: Eligible patients are adults with advanced, unresectable or metastatic solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have progressed after or are intolerant to standard therapies. The trial investigates HRO761, a first-in-human oral allosteric inhibitor of the Werner helicase (WRN), administered alone or in combination with pembrolizumab or irinotecan.

ClinicalTrials.gov ID: NCT05838768

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced 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.

HealthScout AI summary: This trial enrolls adults with advanced, measurable solid tumors (ECOG 0-1) to receive monotherapy with TORL-3-600, an antibody-drug conjugate targeting cadherin 17 (CDH17) with an MMAE payload, particularly relevant for patients with GI cancers such as colorectal, gastric, or pancreatic cancer. Key exclusions include active brain metastases, significant comorbidities, and recent prior cancers.

ClinicalTrials.gov ID: NCT05948826

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.

HealthScout 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

A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

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 study is enrolling adults with advanced, relapsed, or refractory adenoid cystic carcinoma or colorectal carcinoma who have exhausted standard therapies, to receive the oral MYB mRNA-targeting inhibitor RGT-61159. RGT-61159 degrades MYB mRNA via altered splicing and nonsense-mediated decay, aiming to reduce MYB protein in these cancers.

ClinicalTrials.gov ID: NCT06462183

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

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.

HealthScout AI summary: Eligible patients are adults with metastatic or unresectable solid tumors harboring a G12V mutation in KRAS, NRAS, or HRAS who are HLA-A*11:01 positive and have progressed on or declined standard therapies. Treatment involves lymphodepleting chemotherapy followed by infusion of autologous peripheral blood lymphocytes genetically modified to express a murine T-cell receptor targeting the G12V RAS mutation, along with high-dose aldesleukin.

ClinicalTrials.gov ID: NCT03190941