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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.

NCT07148128 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

WEF-001

Starting dose of 0.3 mg/m2 q4wks IV, dose escalation

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • Auricula Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148128 on ClinicalTrials.gov