Clinical Trials for Pancreas Cancer

A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic 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.

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 advanced, unresectable or metastatic pancreatic ductal adenocarcinoma (ECOG 0–1, RECIST-measurable) are randomized to mFOLFIRINOX with or without OT-101, an intravenous antisense oligonucleotide that downregulates TGF-β2 to counter tumor immune evasion and metastasis. Primary endpoint is overall survival, with key secondary endpoints of PFS and ORR.

ClinicalTrials.gov ID: NCT06079346

IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma

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 unresectable PDAC (metastatic or locally advanced) who have completed 16–24 weeks of first-line chemotherapy with no progression (stable disease or partial response), ECOG 0–1, measurable disease, and willingness for paired tumor biopsies. Patients receive maintenance IV odetiglucan (soluble β-glucan innate/myeloid immune activator engaging complement/CR3 pathways) plus IV mitazalimab (agonistic anti-CD40 antibody to activate APCs and promote T-cell priming/macrophage reprogramming), with primary efficacy focused on metastatic patients with partial response after induction chemotherapy.

ClinicalTrials.gov ID: NCT07199764

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

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: Enrolling fit adults (ECOG 0–1) with previously untreated KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma. Patients are randomized to first-line mFOLFIRINOX or NALIRIFOX plus setidegrasib/ASP3082, an IV KRAS G12D-targeted protein degrader, versus placebo plus the same chemotherapy backbone.

ClinicalTrials.gov ID: NCT07409272

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine 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.

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 well-differentiated, locally advanced/metastatic NETs and symptomatic carcinoid syndrome (≥1 daily flushing episode; SRL-naïve or washed out, without recent progression or confounding diarrhea causes) are randomized to oral paltusotine 80 mg daily vs placebo. Paltusotine is an investigational selective SST2 agonist intended to suppress serotonin-mediated symptoms (flushing/diarrhea), with open-label paltusotine available after the blinded period.

ClinicalTrials.gov ID: NCT07087054

A Phase I/IIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

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 EGFR-expressing metastatic pancreatic ductal adenocarcinoma, ECOG 0–1, with measurable disease and progression on first-line 5‑FU–based irinotecan/oxaliplatin therapy (FOLFIRINOX or NALIRIFOX) and no more than one prior metastatic line. Randomized 2:1 to gemcitabine/nab-paclitaxel plus investigational EDV nanocells (EGFR-targeted nanocell delivering the cytotoxic payload PNU-159682 plus a non-targeted α-galactosylceramide–loaded nanocell to activate iNKT-cell immune responses) versus gemcitabine/nab-paclitaxel plus placebo.

ClinicalTrials.gov ID: NCT07049055

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: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)

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 are adults with advanced or metastatic gastric/GEJ adenocarcinoma, NSCLC, or pancreatic ductal adenocarcinoma expressing CEACAM5, who have progressed after 1–3 prior systemic therapies. The trial investigates M9140, an antibody-drug conjugate targeting CEACAM5 and delivering a topoisomerase I inhibitor payload, as monotherapy in these populations.

ClinicalTrials.gov ID: NCT06710132

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant 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, previously treated KRAS G12D-mutant solid tumors (excluding those with CNS involvement or prior direct RAS inhibitor use) to receive the selective KRAS G12D inhibitor RMC-9805, either as monotherapy or combined with the RAS(ON) multi-selective inhibitor RMC-6236. RMC-9805 acts as a molecular glue inducing covalent modification of KRAS G12D, while RMC-6236 targets multiple active KRAS G12X mutations.

ClinicalTrials.gov ID: NCT06040541

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

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 (including HNSCC, NSCLC, mCRC, and PDAC) who have progressed on or lack standard therapies, to evaluate [225Ac]-FPI-2068, an investigational targeted alpha-emitting radiopharmaceutical directed against EGFR and c-MET, with or without FPI-2053 (a bispecific EGFR/c-MET antibody), and includes [111In]-FPI-2107 for diagnostic imaging.

ClinicalTrials.gov ID: NCT06147037

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation

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 pancreatic or non-small cell lung cancer harboring both MTAP loss and a RAS mutation, previously treated with standard therapies, to receive TNG462 (a selective PRMT5 inhibitor exploiting MTAP-deleted tumor vulnerabilities) combined with either RMC-6236 (a multi-RAS mutant inhibitor) or RMC-9805 (a KRAS G12D-selective inhibitor). Prior treatment with RAS-targeted, PRMT5, or MAT2A inhibitors is not allowed.

ClinicalTrials.gov ID: NCT06922591