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NCT Number: NCT07148128

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

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.

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Key information

Conditions

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma Advanced Solid Tumors Advanced or Metastatic KRAS-mutant Tumor Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margareth Cancer Center, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WEF-001

Drug

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

Other names: MMAE-Drug Conjugate

Primary outcomes

  1. Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.

    Time frame: Through study completion, an average of 1 year.

    Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0.

    Frequency of dose interruptions, reductions, and discontinuations. Proportion of participants with DLTs at each dose level.

  2. Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.

    Time frame: Trough study completion, an average of 2 years.

    Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Finn, MSc

CONTACT

[email protected]

1-438-884-9551

Sponsors and collaborators

Lead sponsor

Auricula Biosciences Inc.

Industry

Collaborators

  • Simbec-Orion Group

Registry information

Official study title

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 29, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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