Phase 1/2 Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors

This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment. Monoclonal antibodies, such as VX15/2503, may interfere with the ability of tumor cells to grow and spread.

Principal Investigator:
Kirov, Ivan

Research Coordinator:
Tina Templeman
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 180105
  • Sponsor: Children's Oncology Group
  • Protocol Number: ADVL1614
  • NCT Number: NCT03320330
  • Research Type: Adolescents and Young Adults, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active - Open to Enrollment

Inclusion

  • Part A: ≥ 12 months to < 21 years of age
  • Part B:  ≥ 22 years and ≤ 30 years of age at the time of study enrollment until part A is complete. Part B will expand to include patients ≥ 12 months and ≤ 30 years of age once Part A is complete.
  • Recurrent or refractory solid tumors, excluding CNS tumors
  • Must have either measurable or evaluable disease
  • Prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible.
  • Standard COG Phase 1 organ function requirements

Exclusion

  • Excluded concomitant medications: Corticosteroids (unless on stable dosing), other investigational drugs, other anti-cancer agents, anti-GvHD agents post-transplant

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UC Irvine

CHOC Children's is affiliated with the UC Irvine School of Medicine