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Clinical Trials in the UK / NCT07148128
Recruiting Phase 1/2

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 · tracked via the Priya Life Science UK tracker
Sponsor
Auricula Biosciences Inc
Phase
Phase 1/2
Started
2025-07-28
Last updated
2026-01-29

Condition(s) studied

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

Investigational drug(s) / intervention(s)

WEF-001

WEF-001: Starting dose of 0.3 mg/m2 q4wks IV, dose escalation

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
NEXT Oncology Dallas Dallas Texas Recruiting
Next Oncology, San Antonio San Antonio Texas Recruiting
Princess Margareth Cancer Center Toronto Ontario Recruiting
Oxford University Hospital Headington Oxford Recruiting

Other trials for the same condition

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Recruiting
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors Active, not recruiting
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07148128 on ClinicalTrials.gov ↗ ← All trials in the UK