Recruiting
Phase 1
Phase 2

WEF-001

Sponsor:

Auricula Biosciences Inc.

Code:

NCT07148128

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WEF-001

Study Details

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.

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

Study ID

NCT07148128

Start date

Jul 28, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose selection

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.

Interventions

WEF-001

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

Primary outcome measure

  • 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. ]
  • Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy. [ Time Frame: Trough study completion, an average of 2 years. ]

Central Contacts and Locations

Central contacts

Michele Finn, MSc

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

Locations

NEXT Oncology Dallas

Recruiting

Dallas, Texas, United States, 75230

Contacts

NXT_TXreferrals@nextoncology.com

Principal Investigator:

Shiraj Sen, MD, PhD

Next Oncology, San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

NXT_TXreferrals@nextoncology.com

Principal Investigator:

Anthony Tolcher, MD, FRCPC, FACP, FASCO

Princess Margareth Cancer Center

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Anna Spreafico, MD, PhD

More Information

Sponsor

Auricula Biosciences Inc.

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Auricula Biosciences Inc. on 2026-01-29.