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.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer; Advanced Solid Tumors; Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma; Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer; Advanced or Metastatic KRAS-mutant Tumor

Treatments: Drug: WEF-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07148128

2024-518644-21 (EudraCT Number)

WEF-001-01

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Dose selection

Experimental group

Description:

Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses. Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.

Treatment:

Drug: WEF-001