Clinical Trial 21433

• Overview

  Study Title:

  A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cell engager, in patients with therapy refractory metastatic castration resistant prostate cancer

  Summary:

  This trial is an open-label Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.

  Objective:

  Primary Objectives: Part 1 Dose Escalation To investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC. To determine the recommended Phase 2 dose (RP2D) of LAVA-1207 in patients with therapy refractory mCRPC. Part 2 Expansion Cohort To investigate the safety and tolerability of LAVA-1207 at the RP2D in therapy refractory mCRPC patients with measurable disease. Secondary Objectives Part 1 Dose Escalation and Part 2 Expansion Cohort To explore the preliminary antitumor activity of LAVA-1207. To evaluate the pharmacokinetics of LAVA-1207. To evaluate the pharmacodynamics of LAVA-1207. To evaluate the immunogenicity of LAVA-1207.

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  LAVA-1207 ()

• Inclusion Criteria

  INCLUSION CRITERIA:
  • Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
  • Male patient with mCRPC with measurable or evaluable disease
  • Patient should have failed at least 1 line of taxane-based chemotherapy
  • Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor
  • Patients with evidence of progressive disease
  • Predicted life-expectancy of ≥ 6 months.
  • ECOG performance status of 0 or 1.
  • Surgically sterile
  • Compliant with an effective contraceptive regimen (i.e. use of male condom with female partner and assuring use of an additional highly effective contraceptive method with a failure rate
  • Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures
  • Other criteria may apply

• Exclusion Criteria

  EXCLUSION CRITERIA
  • Uncontrolled or severe intercurrent medical condition.
  • Patient has any active-, uncontrolled-, or suspected infection.
  • Known clinically relevant immunodeficiency disorders.
  • Unstable cardiovascular function
  • Previous treatment with antitumor therapies within 2 weeks prior to initial IMP for radiotherapy and androgen receptor targeted therapy/ androgen biosynthesis inhibitor, and within 4 weeks for systemic chemotherapy or targeted-/ immunotherapy
  • Known ongoing drug and alcohol abuse in the opinion of the investigator.
  • Additional exclusions may apply

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