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

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.

Conditions

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaAdvanced or Metastatic KRAS-mutant Tumor in Colorectal CancerAdvanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung CancerAdvanced Solid TumorsAdvanced or Metastatic KRAS-mutant Tumor
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Related Conditions:

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaAdvanced or Metastatic KRAS-mutant Tumor in Colorectal CancerAdvanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung CancerAdvanced Solid TumorsAdvanced or Metastatic KRAS-mutant Tumor

Study Overview

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Study Details

Study overview

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.

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.

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

Condition
Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Dallas

NEXT Oncology Dallas, Dallas, Texas, United States, 75230

San Antonio

Next Oncology, San Antonio, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Auricula Biosciences Inc.,

Study Record Dates

2028-01