All Trials

A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer

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.

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 previously treated advanced/metastatic pancreatic ductal adenocarcinoma (ECOG 0–1) receive the anti-PAUF monoclonal antibody PBP1510 (ulenistamab)—a first-in-class IgG1 that neutralizes PAUF-mediated ERK/JNK/AKT and TLR2/4 signaling—given as monotherapy in dose escalation and then combined with gemcitabine at RP2D. Prior gemcitabine is allowed (unless stopped for intolerance), and the expansion focuses on PBP1510 plus gemcitabine to assess safety and antitumor activity.

ClinicalTrials.gov ID: NCT05141149

A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

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.

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 CLDN18.2-positive, unresectable locally advanced or metastatic gastric/GEJ or pancreatic adenocarcinoma, ECOG 0–1. Tests the CLDN18.2×CD3 bispecific T‑cell engager ASP2138 as monotherapy and combined with pembrolizumab+mFOLFOX6 (first-line HER2‑negative gastric/GEJ), ramucirumab+paclitaxel (second-line gastric/GEJ), or mFOLFIRINOX (first-line pancreatic).

ClinicalTrials.gov ID: NCT05365581

A Pilot Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

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.

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: For patients ≥12 years with unresectable/metastatic fibrolamellar hepatocellular carcinoma or adults with other solid tumors harboring the DNAJB1‑PRKACA fusion, including checkpoint‑naïve and some checkpoint‑experienced FLC cohorts. Treatment combines an off‑the‑shelf DNAJB1‑PRKACA junction neoepitope peptide vaccine (adjuvanted with TLR1/2 agonist XS15) with nivolumab (PD‑1 inhibitor) and ipilimumab (CTLA‑4 inhibitor) to augment vaccine‑primed T‑cell responses; a re‑enrollment option may use nivolumab plus vaccine if prior CTLA‑4 toxicity.

ClinicalTrials.gov ID: NCT04248569

An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)

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.

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: Pediatric and young adult patients (1–21 years) with relapsed/refractory, AFP-high (≥100 ng/mL), HLA-A2–positive hepatoblastoma, HCN-NOS, or HCC receive a single infusion of autologous ET140203 T cells after lymphodepletion. ET140203 (JWATM-203) is an engineered T-cell therapy using an ARTEMIS receptor with a TCR-mimic that targets AFP158–166/HLA-A*02:01 to selectively kill AFP+/HLA-A2+ liver cancer cells.

ClinicalTrials.gov ID: NCT04634357

First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease

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.

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 advanced primary liver cancers (HCC or cholangiocarcinoma) or solid tumors with liver‑predominant metastases (≤2 extrahepatic sites), ECOG 0–1, receive oral AU409 in 28‑day cycles. AU409 is a first‑in‑class small‑molecule RNA transcription modulator designed to alter liver cancer transcription programs; key exclusions include untreated/symptomatic CNS metastases, significant cardiac risk, Child‑Pugh ≥B7 (for HCC), and strong CYP inducer/inhibitor use.

ClinicalTrials.gov ID: NCT05791448

A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent 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.

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 advanced or recurrent solid tumors lacking standard options receive BP1001-A, a neutral-charge liposomal antisense oligonucleotide targeting GRB2 to inhibit RAS/MAPK and PI3K/AKT signaling; the expansion cohort enrolls recurrent/persistent epithelial ovarian, primary peritoneal, fallopian tube, or endometrial cancers for BP1001-A combined with standard-dose paclitaxel. Key exclusions include CNS disease, significant recent cardiovascular events, inability to receive paclitaxel, and strong CYP3A4/2C8 modulators.

ClinicalTrials.gov ID: NCT04196257

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

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.

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, biopsy-accessible stage III (macroscopic nodal) or stage IV melanoma, ECOG 0–1, and no prior PD‑1/PD‑L1 or CTLA‑4 therapy receive ipilimumab plus nivolumab combined with CBL0137, a non-genotoxic DNA intercalator that traps FACT to activate p53 and suppress NF‑κB/HSF1/MYC. Excludes active autoimmune disease or need for immunosuppression; serial biopsies and blood draws required.

ClinicalTrials.gov ID: NCT05498792

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 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.

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 advanced solid tumors including HNSCC, pancreatic adenocarcinoma, NSCLC, HR+/HER2− breast cancer post‑CDK4/6 inhibitor, or platinum‑resistant high‑grade serous ovarian/related cancers receive the oral CDK7 inhibitor GTAEXS617 (transcription/cell‑cycle regulator) as monotherapy or combined with standard-of-care regimens. Eligible patients have ECOG 0–1 and adequate organ function; study explores safety, PK, and preliminary activity with tumor biopsies required.

ClinicalTrials.gov ID: NCT05985655

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer

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.

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: Eligible patients are adult women with relapsed/refractory locally advanced or metastatic breast cancer (ECOG 0–1) who have progressed after standard therapies or lack standard options; a dose-expansion cohort is restricted to measurable triple-negative disease (ER/PR <10%, HER2-negative) previously treated with at least one active TNBC regimen and with a biopsiable lesion. All participants receive oral OTS167PO, an investigational small-molecule inhibitor of maternal embryonic leucine zipper kinase (MELK), in single-arm dose escalation to define MTD with PK/safety characterization and TNBC expansion at the selected dose.

ClinicalTrials.gov ID: NCT02926690

A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in 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.

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: Enrolls adults with relapsed/refractory or treatment-ineligible advanced/metastatic solid tumors (ECOG 0–1) who have at least two injectable lesions, with emphasis on cutaneous and head/neck cancers (e.g., cSCC, BCC, melanoma, Merkel cell carcinoma, HNSCC) including anti–PD-1–refractory cohorts. Patients receive intratumoral MQ710/MQ719, a non-replicating modified vaccinia Ankara virotherapy (E5R-deleted to enhance cGAS/STING signaling and engineered to express Flt3L and OX40L), given in escalating multi-dose schedules alone or combined with systemic pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT05859074