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

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.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07148128

Enrollment

110

Registered

2025-08-29

Start date

2025-07-28

Completion date

2028-01-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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, Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced Solid Tumors

Keywords

Antineoplastic Agents, Advanced Solid Tumors, Pancreatic Cancer, Colorectal Cancer, KRAS Mutation-Related Tumors, Lung Cancer, Carcinoma, Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer

Brief 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.

Interventions

DRUGWEF-001

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.	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.
Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.	Trough study completion, an average of 2 years.	Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1

Countries

Canada, United Kingdom, United States

Contacts

CONTACTMichele Finn, MSc

inquiries@auriculabiosciences.com1-438-884-9551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026