Clinical Trials for Rectal Cancer

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

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

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 (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

A Study of PARG Inhibitor IDE161 in Participants With Advanced 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 advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

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

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or 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: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264