RECRUITING

Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in 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 Antineoplastic Agents Pancreatic Cancer Colorectal Cancer KRAS Mutation-Related Tumors Lung Cancer Carcinoma, Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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.

Quick Facts

Study Start:2025-07-28

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07148128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Cynthia Cardinal CEO Auricula Biosciences, MSc, PharmD

CONTACT

1-514-452-9046

cynthia.cardinal@auriculabiosciences.com

Study Locations (Sites)

NEXT Oncology Dallas

Dallas, Texas, 75230

United States

Next Oncology, San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Auricula Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-28

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-07-28

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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