Clinical Trials for Pancreas Cancer

A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, 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.

TrialFetch AI summary: Patients with locally advanced or metastatic solid tumors who have exhausted or are unsuitable for standard treatment receive oral OKN4395, an investigational EP2/EP4/DP1 prostanoid receptor antagonist, alone or with the anti–PD-1 antibody pembrolizumab. Expansion cohorts give OKN4395 alone for selected sarcomas and pancreatic adenocarcinoma, and the combination for NSCLC, microsatellite-stable or MSI-low colorectal cancer, and head and neck squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06789172

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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 selected advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive once-weekly intravenous MT-4561, an investigational drug designed to degrade BRD4. Dose escalation is followed by planned dose optimization and an assessment of MT-4561’s effect on oral midazolam pharmacokinetics.

ClinicalTrials.gov ID: NCT06943521

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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.

TrialFetch AI summary: Adults with previously treated unresectable or metastatic KRAS G12D–mutated solid tumors are eligible for dose escalation; dose expansion is limited to pancreatic ductal adenocarcinoma after at least one prior systemic therapy. All receive IV ARV-806, an investigational PROTAC designed to degrade mutant KRAS G12D, weekly or every two weeks.

ClinicalTrials.gov ID: NCT07023731

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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 measurable, unresectable locally advanced or metastatic epithelial carcinomas that have relapsed or are refractory after at least two prior treatment lines, have no standard options, and have ECOG performance status 0–1 receive DR-0202 every two weeks. DR-0202 is an investigational bispecific antibody designed to bring myeloid immune cells into contact with tumor cells; its tumor-cell target has not been disclosed.

ClinicalTrials.gov ID: NCT06999187

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy 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.

TrialFetch AI summary: Adults with advanced solid tumors, particularly BRCA1/2-mutated or other homologous-recombination–deficient cancers, receive oral XL309, an investigational USP1 inhibitor that disrupts DNA repair, alone or with the PARP inhibitor olaparib. Cohorts include breast, castration-resistant prostate, pancreatic, and platinum-sensitive or platinum-resistant ovarian cancer.

ClinicalTrials.gov ID: NCT05932862

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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 or metastatic TP53 R175H-mutant solid tumors who are HLA-A*02:01-positive and have exhausted standard options receive CLSP-1025 monotherapy. This investigational T-cell engager binds CD3 and an HLA-A*02:01-presented mutant p53 peptide to direct T-cell killing of tumor cells.

ClinicalTrials.gov ID: NCT06778863

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

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: Eligible patients are adults with metastatic, refractory gastrointestinal, hepatobiliary, genitourinary, breast, ovarian, endometrial, or selected endocrine/neuroendocrine tumors who have failed standard therapies and have a resectable lesion for TIL generation. Treatment includes lymphodepleting chemotherapy, autologous tumor-infiltrating lymphocyte (TIL) infusion, high-dose aldesleukin, and pembrolizumab, a PD-1 immune checkpoint inhibitor, with timing of pembrolizumab varying by study arm.

ClinicalTrials.gov ID: NCT01174121

SHARON: Study of Metastatic Cancers in Patients With a Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives

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: This trial enrolls adults with metastatic pancreatic (ductal or acinar) or HER2-negative breast cancer harboring BRCA1, BRCA2, or PALB2 mutations, and treats them with high-dose melphalan and BCNU in combination with vitamin B12b, escalating doses of vitamin C, and low-dose ethanol, followed by autologous hematopoietic stem cell rescue. The investigational regimen aims to overcome drug resistance in homologous recombination-deficient tumors by exploiting oxidative stress pathways.

ClinicalTrials.gov ID: NCT04150042

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or 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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic solid tumors who have exhausted, are ineligible for, or decline standard therapy receive IV AGX101 in dose-escalation or expansion cohorts, including a planned advanced angiosarcoma cohort. AGX101 is an antibody–drug conjugate targeting TM4SF1 on tumor cells and tumor-associated blood vessels that delivers a maytansinoid tubulin inhibitor.

ClinicalTrials.gov ID: NCT06440005

A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

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 unresectable or metastatic solid tumors after standard treatment, or multiple myeloma after at least three prior regimens including a proteasome inhibitor, IMiD, and anti-CD38 therapy, receive intravenous QXL138AM every two weeks. QXL138AM is a masked anti-CD138 antibody–interferon-alpha fusion designed to activate interferon signaling near CD138-expressing cancer cells.

ClinicalTrials.gov ID: NCT06582017