NCT07148128phase 1 2recruiting

Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.

Auricula Biosciences Inc. · with Simbec-Orion Group

ClinicalTrials.gov

110

Enrollment · estimated

Countries · 4 sites

2028-01

Primary completion

7 mo ago

Record updated

Commercial relevance

No explicit biomarker / molecular-testing language identified in the public record.

Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial

New trial
42/100
Opportunity
New phase 1_2 trial NCT07148128 posted by Auricula Biosciences Inc.: "Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.".
ClinicalTrials.gov record updated 222 days ago.

Eligibility — raw, for validation

Inclusion Criteria:

* Advanced KRAS-mutant solid tumor: pancreatic ductal adenocarcinoma, colorectal cancer, non small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma or urothelial bladder cancer
* Progressive disease following at least one line of standard of care therapy
* Measurable disease as defined by RECIST v1.1
* ECOG ≤ 1

Exclusion Criteria:

* Active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP
* Active cardiovascular disease
* Having a second active primary malignancy, requiring systemic administration of any cancer-related therapy
* Liver dysfunction
* Untreated brain metastasis and/or unstable neurological dysfunction
* Inflammatory bowel disease
* Active and untreated hyperthyroidism
* Lupus erythematosus within past 5 years