Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.

Part of paid clinical trials in Dallas, Texas.

Sponsor
Auricula Biosciences Inc.
Study ID
NCT07148128
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • Advanced or Metastatic KRAS-mutant Tumor
  • Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer
  • Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer
  • Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WEF-001 — DRUG
    Starting dose of 0.3 mg/m2 q4wks IV, dose escalation

Study Details

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.

Key Dates

Start date
Jul 28, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NEXT Oncology DallasDallasTexas75230
Shiraj Sen, MD, PhD (PRINCIPAL_INVESTIGATOR)
Next Oncology, San AntonioSan AntonioTexas78229
Anthony Tolcher, MD, FRCPC, FACP, FASCO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By research site
NEXT Oncology Dallas· Dallas, TXNext Oncology, San Antonio· San Antonio, TX

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