Open Actively Recruiting

Phase 2 Study of DKN-01 in Colorectal Cancer

About

Brief Summary

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) [FOLFIRI/FOLFOX and bevacizumab] as second-line treatment of advanced CRC patients.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult patients with advanced CRC with measurable disease (RECIST v1.1) who have radiographically progressed during or following one line of systemic treatment will be enrolled in the study.

Inclusion Criteria:

Patients meeting all of the following criteria will be considered eligible for study entry:

  • Disease progression following first-line systemic therapy with any fluoropyrimidine-based regimen for advanced disease (except FOLFOXIRI, see exclusion criteria).
    • Patients may have received prior neoadjuvant or adjuvant therapy which could have included irinotecan or oxaliplatin. If progression has occurred within 6 months from last dose of neoadjuvant or adjuvant treatment, this regimen will be considered as the one line of systemic therapy for advanced disease.
      • If assigned to receive FOLFIRI, patient may have received no prior irinotecan as part of first-line systemic therapy.
      • If assigned to receive FOLFOX, patient may have received no prior oxaliplatin as part of first line systemic therapy.
      • Prior treatment with an anti-VEGF or anti-EGFR therapy is allowed as first-line and/or maintenance systemic therapy.
  • Able to provide written informed consent for any study specific procedures.
  • One or more tumors measurable on radiographic imaging as defined by RECIST 1.1
  • Sufficient tumor tissue for mandatory pre-treatment evaluation (fresh biopsy [preferred], or archived tissue block specimen).
  • ECOG performance status ≤1 within 7 days of first dose of study drug. Acceptable liver, renal, hematologic, and coagulation function
  • Females of childbearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for study entry:

  • Diagnosis of Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAF V600E mutation positive colorectal cancer.
  • Prior therapy with an anti-DKK1, FOLFOXIRI, PD-1, anti-PD-L1, anti-PD-L-2 or any other antibody or drug specifically targeting T-cell co-stimulation or coinhibitory checkpoint.
  • Systemic anti-cancer therapy within 28 days prior to first dose of study drug.
  • Major surgery within 28 days prior to first dose of study drug.
  • Prior radiation therapy within 14 days prior to first dose of study drug.
  • Active leptomeningeal disease or uncontrolled brain metastases.
  • Any active cancer ≤ 2 years before first dose of study drug with the exception of cancer for this study.
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
  • Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
  • Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study entry requiring systemic therapy.
  • Serious nonmalignant disease
  • Pregnant or nursing.
  • History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
  • Known osteoblastic bony metastasis.
  • Major surgery 28 days prior to study entry.
  • Prior radiation therapy within 14 days prior to study entry.
  • Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient.
  • Active substance abuse.
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Administration of a live vaccine within 28 days before first dose of study drug

Join this Trial

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Study Stats
Protocol No.
22-001187
Category
Hematology-Oncology
Oncology
Contact
Lisa Yonemoto
Location
  • UCLA Burbank
  • UCLA San Luis Obispo
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05480306
For detailed technical eligibility, visit ClinicalTrials.gov.