Clinical Trials for Rectal Cancer

A Phase I, Single-Center, Dose Escalation Trial of Heterologous Prime-Boost Vaccination With Ad5.F35-hGUCY2C-PADRE and Lm-GUCY2C Vaccines in Adults With Advanced Colorectal and Small Bowel Adenocarcinomas

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 locally advanced or metastatic colorectal or small bowel adenocarcinoma after progression on or intolerance/ineligibility for standard therapy receive heterologous GUCY2C-targeted vaccination. Treatment consists of intramuscular Ad5.F35-hGUCY2C-PADRE priming, an adenoviral vector encoding the tumor-associated antigen guanylyl cyclase C plus PADRE, followed by two IV live-attenuated Listeria monocytogenes GUCY2C boosts to enhance GUCY2C-specific cellular immunity.

ClinicalTrials.gov ID: NCT07417488

A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With 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: Enrolls adults with metastatic microsatellite-stable/mismatch-repair–proficient colorectal adenocarcinoma after progression on standard metastatic therapy, with measurable disease and ECOG 0–1. Treatment is CEA-PRIT 2.0: CEA/CEACAM5-targeting SPLIT antibodies followed by DOTAM radioligand, using 203Pb-DOTAM for imaging dosimetry and therapeutic alpha-emitting 212Pb-DOTAM to deliver targeted radiation to CEA-expressing tumors.

ClinicalTrials.gov ID: NCT07416552

A Phase 1 Study of IM-1617 in Participants With Advanced 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: Patients with ECOG 0–2 and measurable, unresectable locally advanced or metastatic solid tumors, including colorectal cancer, NSCLC, breast cancer, and upper GI adenocarcinomas; expansion focuses on refractory colorectal cancer and NSCLC. All receive IV IM-1617, an antibody–drug conjugate targeting an undisclosed receptor tyrosine kinase and delivering the HC74 topoisomerase-I inhibitor payload.

ClinicalTrials.gov ID: NCT07578571

Phase 1/2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

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 CDH17-positive gastric or gastroesophageal-junction adenocarcinoma after failure of or ineligibility for standard/curative therapy receive intravenous BHB810 every 2 weeks. BHB810 is a CDH17-directed antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE to CDH17-expressing tumor cells.

ClinicalTrials.gov ID: NCT07529808

A Phase 1/2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations

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 previously treated metastatic pancreatic ductal adenocarcinoma, NSCLC, or colorectal cancer harboring KRAS G12C/D/V/A/S or G13D mutations, measurable disease, and ECOG 0–1 are eligible. Participants receive oral once-daily BLU-924 (SAR449336), an investigational pan-KRAS small-molecule inhibitor, as monotherapy.

ClinicalTrials.gov ID: NCT07629960

Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable 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 untreated, measurable microsatellite-stable metastatic colorectal cancer and ECOG 0–1 receive first-line FOLFOX6 plus investigational SAR445877, a bifunctional anti–PD-1/IL-15 fusion protein that activates cytotoxic T and NK cells; bevacizumab is included during dose escalation but is not listed in the expansion regimen.

ClinicalTrials.gov ID: NCT07500298

Phase I, Open-Label Study of Autologous Mutant KRAS and ILT4-Redirected T-cell Receptor Cells (TCR1188-ABC)

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 HLA-A*11:01-positive, KRAS G12V-mutant metastatic pancreatic, biliary, colorectal, or non-small cell lung cancer after standard therapy receive fludarabine/cyclophosphamide lymphodepletion followed by a single infusion of autologous TCR-engineered T cells recognizing HLA-A*11:01-presented KRAS G12V and targeting ILT4/LILRB2-positive immunosuppressive cells; prophylactic tocilizumab is given on day 2.

ClinicalTrials.gov ID: NCT07594067

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.

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 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 I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents 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.

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 advanced or metastatic solid tumors—including specific cohorts for EGFR-mutant or wild-type NSCLC, HNSCC, and metastatic CRC—to investigate AZD9592, a bispecific antibody-drug conjugate targeting EGFR and cMET, given alone or in combination with standard therapies such as osimertinib or 5-FU/bevacizumab/leucovorin. Key exclusions are active ILD/pneumonitis, untreated or unstable brain metastases, active infections, or significant cardiac disease.

ClinicalTrials.gov ID: NCT05647122

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

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.

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 study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626