Clinical Trial 22437

• Overview

  Study Title:

  A Phase 2a, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating LSTA1 when Added to Standard of Care (SoC) Versus Standard of Care Alone in Subjects with Advanced Solid Tumors

  Objective:

  Primary Objective To evaluate the safety and tolerability of LSTA1 when added to SoC in patients with advanced solid tumors. Secondary Objectives To determine the therapeutic effect of LSTA1 when added to SoC in patients with advanced solid tumors on: Overall survival (OS) 12-month survival Progression-free survival (PFS) Duration of response (DOR) in responding patients with measurable disease at baseline − Objective response rate (ORR) − Duration of response (DOR) To evaluate the safety profile of LSTA1 when administered as monotherapy during the run-in period To evaluate the dose tolerance of SoC therapy when administered along with LSTA1. Pharmacodynamic Objectives For the CCA cohort, disease biomarkers CA19-9, carcinoembryonic antigen (CEA), and CA125 will be assessed pre-dose (within 72 hours prior to dosing) at run-in and on Day 1 of each Cycle and at EOT. For all cohorts, retrospective assessment of tissue biomarkers in optional pre-treatment archival tissue (or pre-treatment core biopsy) and on-treatment optional core biopsy will be assessed. Pharmacokinetic Objectives To characterize the PK profile of LSTA1 when administered with standard of care therapies. To characterize the population PK profile of LSTA1 when administered in combination with SoC therapies.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

  Medications:

  AMP-514 (Durvalumab); Durvalumab (); Gemzar (gemcitabine); LSTA1 (); MEDI4736 (Durvalumab); Placebo (); Taxotere (docetaxel); cisplatin (); docetaxel (); gemcitabine ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Subjects must be at least 18 years of age at time of consent and provide informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of 3 months or more, as determined by the investigator.
  • At least one bidimensional measurable metastatic lesion assessed by RECIST 1.1. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion, or the lesion persists three months after radiotherapy. Additionally, a biopsy site should not be considered a target lesion.
  • Adequate organ and marrow function as defined by the protocol.
  • Adequate contraception as defined by the protocol.
  • Patients with histologically confirmed recurrent or metastatic HNSCC that is unresectable or considered incurable by local therapies and that has progressed after first-line immunotherapy.
  • The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have primary tumor sites of the skin, paranasal sinuses, or the nasopharynx (any histology).
  • Additional Criteria will apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Subjects with a known sensitivity to LSTA1 or its excipients.
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  • Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, and other anti-tumor therapy within 28 days prior to randomization.
  • Additional Criteria will apply

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