Clinical Trials /

A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

NCT03013218

Description:

A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma

Related Conditions:
  • Malignant Solid Tumor
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma
  • Official Title: A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: AT148001
  • NCT ID: NCT03013218

Conditions

  • Metastatic Cancer
  • Solid Tumor
  • Advanced Cancer
  • NonHodgkin Lymphoma

Interventions

DrugSynonymsArms
ALX148ALX148
AtezolizumabTecentriqALX148 + Atezolizumab
TrastuzumabHerceptinALX148 + Trastuzumab

Purpose

A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma

Detailed Description

      This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose,
      dose-escalation, safety, PK, and PD study of ALX148. The phase 1 protocol will have 2 parts:
      a single agent dose escalation phase (Part 1) and a combination therapy phase (Part 2). Part
      2 will include an initial dose escalation portion followed by a dose expansion portion.
      Approximately 110 adult patients are expected to be enrolled in the study.
    

Trial Arms

NameTypeDescriptionInterventions
ALX148ExperimentalThe Part 1 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks.
  • ALX148
ALX148 + AtezolizumabExperimentalThe Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with atezolizumab infusions administered every three weeks.
  • ALX148
  • Atezolizumab
ALX148 + TrastuzumabExperimentalThe Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with trastuzumab infusions administered every three weeks.
  • ALX148
  • Trastuzumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
             that is resistant to standard therapy or for which no standard therapy is available;
             or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is
             available.

          -  Adequate Bone Marrow Function.

          -  Adequate Renal & Liver Function.

          -  Adequate Performance Status

        Exclusion Criteria:

          -  Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring
             steroids.

          -  Previous high-dose chemotherapy requiring stem cell rescue.

          -  Prior irradiation to >25% of the bone marrow.

          -  Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting
             agent.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities (Number of participants with a DLT)
Time Frame:Up to 28 days
Safety Issue:
Description:Number of participants with a DLT

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Alexo Therapeutics, Inc.

Trial Keywords

  • Neoplasms
  • CD47
  • SIRPα
  • ALX148

Last Updated

March 22, 2017