Clinical Trials for Rectal Cancer

A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 pMMR/MSS metastatic colorectal cancer and measurable liver metastases receive balstilimab (anti-PD-1), botensilimab (Fc-enhanced anti-CTLA-4), and agenT-797, an allogeneic invariant natural killer T-cell therapy that recognizes CD1d-presented glycolipid antigens. Patients must have received fluorouracil, oxaliplatin, and irinotecan, plus an EGFR inhibitor or bevacizumab when appropriate, and must not have had prior immunotherapy.

ClinicalTrials.gov ID: NCT07550088

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

Active drug

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

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 recurrent IDH-mutant astrocytoma or IDH-wildtype glioblastoma after radiation-based treatment receive oral NEO212 alone; patients with selected solid tumors and brain metastases uncontrolled by surgery or radiation receive it with tumor-appropriate standard-of-care therapy. NEO212 is an investigational temozolomide–perillyl alcohol conjugate that acts as a DNA-alkylating agent.

ClinicalTrials.gov ID: NCT06047379

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects with Advanced, Metastatic, and Progressive Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

No known activity

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

TrialFetch AI summary: Adults with progressive metastatic colorectal cancer who have exhausted, cannot tolerate, or declined standard therapies are randomized within ENPP1/cGAS biomarker groups to oral RBS2418 plus best supportive care or placebo plus best supportive care. RBS2418 inhibits ENPP1 to preserve extracellular cGAMP and promote antitumor immune activity.

ClinicalTrials.gov ID: NCT06824064

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 ECOG 0–1, measurable disease, and an injectable, biopsiable lesion may enroll in cohorts for untreated PD-L1-positive advanced head and neck squamous-cell carcinoma or advanced melanoma progressing on or after anti-PD-(L)1 therapy; the previously treated, non–MSI-high advanced colorectal cancer cohort is closed. Treatment combines intratumoral VV1, an engineered oncolytic virus designed to kill tumor cells and stimulate immunity, with intravenous cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT04291105

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 or metastatic endometrial, gastric, castration-resistant prostate, ovarian, colorectal, urothelial, or biliary tract cancer receive datopotamab deruxtecan, a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, either alone or in tumor-specific combinations. Combination partners include fluoropyrimidines, platinum chemotherapy, bevacizumab, corticosteroids, or the investigational bispecific antibodies volrustomig (PD-1/CTLA-4) and rilvegostomig (PD-1/TIGIT).

ClinicalTrials.gov ID: NCT05489211

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 measurable metastatic or recurrent/refractory HPV16-positive cancer who are HLA-A*02:01-positive and have received or declined standard therapy receive cyclophosphamide/fludarabine lymphodepletion, followed by a single infusion of autologous TCR-engineered T cells targeting HPV16 E7 presented by HLA-A*02:01 and adjuvant aldesleukin.

ClinicalTrials.gov ID: NCT05686226

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

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

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.

TrialFetch AI summary: Adults with measurable, locally advanced or metastatic solid tumors and ECOG performance status 0–1 receive MDNA11 alone or with pembrolizumab. MDNA11 is a long-acting IL-2 agonist designed to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT05086692

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

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, recurrent unresectable, locally advanced, or metastatic EGFR-expressing solid tumors are eligible if they are germline HLA-A*02 heterozygous and their tumors have lost HLA-A*02 expression. After lymphodepleting chemotherapy, patients receive a single infusion of A2B395, an allogeneic CAR T-cell therapy designed to target EGFR-positive cells while sparing healthy cells that retain HLA-A*02.

ClinicalTrials.gov ID: NCT06682793

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable locally advanced or metastatic KRAS-mutant or KRAS-amplified solid tumors, including NSCLC, pancreatic ductal adenocarcinoma, and colorectal cancer, receive oral BBO-11818, a noncovalent pan-KRAS inhibitor, alone or with pembrolizumab, pembrolizumab plus platinum/pemetrexed chemotherapy, or cetuximab. Eligible patients must have measurable disease and ECOG performance status 0–1.

ClinicalTrials.gov ID: NCT06917079

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 have measurable, unresectable locally advanced or metastatic HER2-positive or HR-positive/HER2-negative breast cancer, KRAS-mutant colorectal cancer, or KRAS-mutant non-small cell lung cancer, with ECOG performance status 0–1. Treatment is oral BBO-10203, an investigational inhibitor of RAS-mediated PI3Kα activation, alone or with trastuzumab in the breast cancer cohorts.

ClinicalTrials.gov ID: NCT06625775