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 1Lead Sponsor
ALX OncologyStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Metastatic Cancer Solid Tumor Advanced Cancer NonHodgkin LymphomaIntervention/Treatment
alx148 atezolizumab trastuzumab ...Study Participants
174A 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.
Evorpacept (ALX148)
Keytruda
Herceptin
Rituxan
Standard of care chemotherapy
Standard of care chemotherapy
The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
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.
