Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Active, not recruiting
  • Intervention/Treatment

    alx148 atezolizumab trastuzumab ...
  • Study Participants

    174
A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma
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.
Study Started
Feb 03
2017
Primary Completion
Feb 01
2022
Study Completion
Feb 01
2023
Anticipated
Last Update
Jul 21
2022

Drug Evorpacept (ALX148)

Evorpacept (ALX148)

Drug Pembrolizumab

Keytruda

Drug Trastuzumab

Herceptin

Drug Rituximab

Rituxan

Drug Ramucirumab + Paclitaxel

Standard of care chemotherapy

Drug 5-FU + Cisplatin

Standard of care chemotherapy

Evorpacept (ALX148) Experimental

The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.

Evorpacept (ALX148) + Pembrolizumab Experimental

The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.

Evorpacept (ALX148) + Trastuzumab Experimental

The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.

Evorpacept (ALX148) + Rituximab Experimental

The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.

Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum Experimental

The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.

Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel Experimental

The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.

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.
No Results Posted