NCT07148128

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
21mo left

Started Jul 2025

Typical duration for phase_1

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jul 2025Jan 2028

First Submitted

Initial submission to the registry

June 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

June 25, 2025

Last Update Submit

January 27, 2026

Conditions

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

Keywords

Antineoplastic AgentsAdvanced Solid TumorsPancreatic CancerColorectal CancerKRAS Mutation-Related TumorsLung CancerCarcinoma, Non-Small Cell Lung CancerNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

    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.

    Through study completion, an average of 1 year.

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

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

    Trough study completion, an average of 2 years.

Study Arms (1)

Dose selection

EXPERIMENTAL

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.

Drug: WEF-001

Interventions

WEF-001DRUG

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

Also known as: MMAE-Drug Conjugate
Dose selection

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NEXT Oncology Dallas

Dallas, Texas, 75230, United States

RECRUITING

Next Oncology, San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Princess Margareth Cancer Center

Toronto, Ontario, Canada

RECRUITING

Oxford University Hospital

Headington, Oxford, 0X3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal NeoplasmsLung NeoplasmsCarcinomaCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

Michele Finn, MSc

CONTACT

1-438-884-9551inquiries@auriculabiosciences.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

August 29, 2025

Study Start

July 28, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)GB(1)CA(1)