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RecruitingInterventionalPhase 1/Phase 2

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.

NCT ID: NCT07148128Sponsor: Auricula Biosciences Inc.Last updated: 2026-01-29

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.

Arms & interventions

  • DrugWEF-001

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

Outcome measures

Primary

  • 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.

    Time frame: 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

    Time frame: Trough study completion, an average of 2 years.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (2)

NEXT Oncology Dallas

Dallas, Texas, 75230

Recruiting
Shiraj Sen, MD, PhD · Principal Investigator

Next Oncology, San Antonio

San Antonio, Texas, 78229

Recruiting
Anthony Tolcher, MD, FRCPC, FACP, FASCO · Principal Investigator
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours. | Cancerify