Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaPhase 1/2NCT07148128
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
A Phase 1/2 study testing WEF-001 in people with Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma and Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, run by Auricula Biosciences Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- WEF-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 28 Jul 2025to Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
NEXT Oncology Dallas
Dallas, Texas, 75230
NXT_TXreferrals@nextoncology.com
Shiraj Sen, MD, PhD
- Recruiting
Next Oncology, San Antonio
San Antonio, Texas, 78229
NXT_TXreferrals@nextoncology.com
Anthony Tolcher, MD, FRCPC, FACP, FASCO
Canada1 site, 1 recruiting
- Recruiting
Princess Margareth Cancer Center
Toronto, Ontario
Anna Spreafico, MD, PhD
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospital
Headington, Oxford, 0X3 9DU
Mark Middleton, MD, FRCP (UK), PhD
Magdalena Kielak, MD
About this study
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.
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
- Being tested
- WEF-001
- 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
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEF-001Drug
Also called MMAE-Drug Conjugate
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: WEF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Trough study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start28 Jul 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auricula Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148128
- Sponsor's protocol ID
- WEF-001-01
- Other IDs
- 2024-518644-21
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07148128
- Acronym / sponsor ID
- WEF-001-01
- 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
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Auricula Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose selection | Experimental | Drug: WEF-001Phase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEF-001Also: MMAE-Drug ConjugateStarting dose of 0.3 mg/m2 q4wks IV, dose escalation | Drug | Dose selection |
Primary outcome
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.
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.
Time frame: Trough study completion, an average of 2 years.
Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WEF-001 in people with Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma and Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, run by Auricula Biosciences Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Finn, MSc (1-438-884-9551, inquiries@auriculabiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.