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

ALX Oncology

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer; Solid Tumor; Metastatic Cancer; NonHodgkin Lymphoma

Treatments: Drug: Trastuzumab; Drug: Pembrolizumab; Drug: 5-FU + Cisplatin; Drug: Evorpacept (ALX148); Drug: Rituximab; Drug: Ramucirumab + Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03013218

AT148001

Details and patient eligibility

About

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

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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174 participants in 6 patient groups

Evorpacept (ALX148)

Experimental group

Description:

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

Treatment:

Drug: Evorpacept (ALX148)

Evorpacept (ALX148) + Pembrolizumab

Experimental group

Description:

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

Treatment:

Drug: Evorpacept (ALX148)

Drug: Pembrolizumab

Evorpacept (ALX148) + Trastuzumab

Experimental group

Description:

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

Treatment:

Drug: Evorpacept (ALX148)

Drug: Trastuzumab

Evorpacept (ALX148) + Rituximab

Experimental group

Description:

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

Treatment:

Drug: Rituximab

Drug: Evorpacept (ALX148)

Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum

Experimental group

Description:

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

Treatment:

Drug: Evorpacept (ALX148)

Drug: 5-FU + Cisplatin

Drug: Pembrolizumab

Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Ramucirumab + Paclitaxel

Drug: Evorpacept (ALX148)

Drug: Trastuzumab