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

RECRUITINGPhase 1/2Sponsored by Auricula Biosciences Inc.
Actively Recruiting
PhasePhase 1/2
SponsorAuricula Biosciences Inc.
Started2025-07-28
Est. completion2028-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions7

Advanced Solid TumorsAdvanced or Metastatic KRAS-mutant TumorAdvanced or Metastatic KRAS-mutant Tumor in Colorectal CancerAdvanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung CancerAdvanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaCancerLung Cancer

Locations2 sites

NEXT Oncology Dallas
Dallas, Texas, 75230
Next Oncology, San Antonio
San Antonio, Texas, 78229

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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