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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Metastatic Cancer, Solid Tumor, Advanced Cancer, NonHodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Evorpacept (ALX148)
* Drug: Pembrolizumab
* Drug: Trastuzumab
* Drug: Rituximab
* Drug: Ramucirumab + Paclitaxel
* Drug: 5-FU + Cisplatin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evorpacept (ALX148)<br>The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>|
| Experimental: Evorpacept (ALX148) + Pembrolizumab<br>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>Drug: Pembrolizumab<br>* Keytruda<br>|
| Experimental: Evorpacept (ALX148) + Trastuzumab<br>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>Drug: Trastuzumab<br>* Herceptin<br>|
| Experimental: Evorpacept (ALX148) + Rituximab<br>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>Drug: Rituximab<br>* Rituxan<br>|
| Experimental: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum<br>The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>Drug: Pembrolizumab<br>* Keytruda<br>Drug: 5-FU + Cisplatin<br>* Standard of care chemotherapy<br>|
| Experimental: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel<br>The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions. | Drug: Evorpacept (ALX148)<br>* Evorpacept (ALX148)<br>Drug: Trastuzumab<br>* Herceptin<br>Drug: Ramucirumab + Paclitaxel<br>* Standard of care chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities (Number of participants with a DLT) | Number of participants with a DLT | Up to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasms, CD47, SIRPα, ALX148, Evorpacept