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NCT03013218 Clinical Trial

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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03013218
Other study ID # AT148001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 3, 2017
Est. completion date December 1, 2024

Study information
Verified date March 2024
Source ALX Oncology Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 174
Est. completion date December 1, 2024
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evorpacept (ALX148)
Evorpacept (ALX148)
• Pembrolizumab
Keytruda
• Trastuzumab
Herceptin
• Rituximab
Rituxan
• Ramucirumab + Paclitaxel
Standard of care chemotherapy
• 5-FU + Cisplatin
Standard of care chemotherapy

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Colorado Denver Denver Colorado
United States START-Midwest Grand Rapids Michigan
United States Yale University New Haven Connecticut
United States Seattle Cancer Care Alliance Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
ALX Oncology Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicities (Number of participants with a DLT) Number of participants with a DLT Up to 28 days
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