Clinical Trials for Rectal Cancer

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

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: This trial enrolls adults with either HER2-positive metastatic breast cancer that has progressed after prior therapy including T-DXd, or RAS/BRAF wild-type, pMMR/MSS metastatic colorectal cancer that has progressed after oxaliplatin-based first-line therapy, to receive the investigational CD47-blocking fusion protein evorpacept (which enhances macrophage-mediated phagocytosis) in combination with trastuzumab plus chemotherapy or with cetuximab and FOLFIRI, respectively. Candidates must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT07007559

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors

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 adult patients with advanced, relapsed, or treatment-refractory solid tumors—including specific expansion cohorts for breast, pancreatic, ovarian, or colorectal cancer—may receive SON-DP, a first-in-class investigational protein that reprograms malignant cells into normal tissue cells rather than killing them, via IV infusion.

ClinicalTrials.gov ID: NCT05989724

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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: This trial enrolls adults with advanced or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

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: This trial enrolls adults with unresectable or metastatic, mismatch repair-proficient colorectal cancer or pancreatic ductal adenocarcinoma harboring vaccine-covered KRAS mutations who have progressed after first-line chemotherapy, and treats them with a mutant KRAS-targeted peptide vaccine plus balstilimab (anti-PD-1) and botensilimab (Fc-enhanced anti-CTLA-4). Immunotherapy-naive patients with measurable disease and good performance status are eligible.

ClinicalTrials.gov ID: NCT06411691

A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774

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: This trial enrolls adults with advanced metastatic solid tumors—particularly those with MGMT promoter hypermethylation or for whom temozolomide is standard therapy—and evaluates the combination of oral temozolomide with tuvusertib (M1774), a selective ATR kinase inhibitor that targets the DNA damage response pathway. The phase 2 focus is on patients with mismatch repair proficient/microsatellite stable colorectal cancer with MGMT promoter hypermethylation.

ClinicalTrials.gov ID: NCT05691491

A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

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: This trial enrolls adults with metastatic or unresectable, RAS-mutant colorectal or pancreatic cancer (including KRAS G12D subsets), and tests oral RAS(ON) inhibitors—RMC-6236 (a multi-selective tri-complex RAS inhibitor) and RMC-9805 (a KRAS G12D-selective molecular glue)—either as monotherapy or combined with standard therapies such as mFOLFOX6, mFOLFIRINOX, gemcitabine/nab-paclitaxel, bevacizumab, or cetuximab. All patients must have ECOG 0-1 and adequate organ function.

ClinicalTrials.gov ID: NCT06445062

Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With Solid Tumors

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: This trial enrolls adults with metastatic or unresectable solid tumors—including those with prior exposure to fluorouracil or capecitabine—to receive the BET bromodomain inhibitor ZEN003694 (which disrupts BRD4-mediated oncogenic transcription) in combination with capecitabine. Expansion cohorts specifically include metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT05803382

A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E Metastatic Colorectal Cancer

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: This trial enrolls adults with refractory, BRAF V600E-mutant metastatic colorectal cancer who have previously tolerated encorafenib plus cetuximab, and evaluates the addition of ZEN003694, a pan-BET bromodomain inhibitor, to ongoing encorafenib and cetuximab therapy. Patients must have good performance status and adequate organ function, and may have stable or treated brain metastases.

ClinicalTrials.gov ID: NCT06102902

A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients with KRAS-Mutant Metastatic Colorectal Cancer

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: This trial enrolls adults with microsatellite stable, KRAS-mutant metastatic colorectal cancer who have progressed on or are intolerant of standard chemotherapy, and excludes those with diabetes or prior anti-PD1/CTLA-4 therapy. Patients receive combination therapy with botensilimab (Fc-engineered anti-CTLA-4 antibody), balstilimab (anti-PD-1 antibody), a fasting-mimicking diet, and high-dose intravenous vitamin C.

ClinicalTrials.gov ID: NCT06336902

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

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: This trial enrolls adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma (excluding MSI-H/dMMR) to receive FOLFOX and bevacizumab combined with emavusertib (CA-4948), a selective IRAK4 inhibitor targeting the TLR/IL-1R/NF-κB pathway. Key exclusions include prior FOLFOX, bevacizumab, or antiangiogenic therapy in the metastatic setting.

ClinicalTrials.gov ID: NCT06696768