Clinical Trials /

A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

NCT03013218

Description:

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

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

Active, not recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03013218

Trial Eligibility

Document

Title

  • Brief Title: A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
  • Official Title: A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

Clinical Trial IDs

  • ORG STUDY ID: AT148001
  • NCT ID: NCT03013218

Conditions

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

Interventions

DrugSynonymsArms
Evorpacept (ALX148)Evorpacept (ALX148)
PembrolizumabEvorpacept (ALX148) + Pembrolizumab
TrastuzumabEvorpacept (ALX148) + Trastuzumab
RituximabEvorpacept (ALX148) + Rituximab
Ramucirumab + PaclitaxelEvorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
5-FU + CisplatinEvorpacept (ALX148) + Pembrolizumab + 5FU + Platinum

Purpose

A phase 1, dose escalation study of evorpacept (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 evorpacept (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 184 adult patients are expected to be enrolled in the study.

Trial Arms

NameTypeDescriptionInterventions
Evorpacept (ALX148)ExperimentalThe Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
  • Evorpacept (ALX148)
Evorpacept (ALX148) + PembrolizumabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
  • Evorpacept (ALX148)
  • Pembrolizumab
Evorpacept (ALX148) + TrastuzumabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
  • Evorpacept (ALX148)
  • Trastuzumab
Evorpacept (ALX148) + RituximabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
  • Evorpacept (ALX148)
  • Rituximab
Evorpacept (ALX148) + Pembrolizumab + 5FU + PlatinumExperimentalThe Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
  • Evorpacept (ALX148)
  • Pembrolizumab
  • 5-FU + Cisplatin
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + PaclitaxelExperimentalThe Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
  • Evorpacept (ALX148)
  • Trastuzumab
  • Ramucirumab + Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy;
             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 allogenic stem cell rescue.

          -  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:Active, not recruiting
Lead Sponsor:ALX Oncology Inc.

Trial Keywords

  • Neoplasms
  • CD47
  • SIRPα
  • ALX148
  • Evorpacept

Last Updated

August 27, 2021