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

Sponsor

ALX Oncology Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03013218

Collaborator

(none)

174

Enrollment

Locations

Arms

71.9

Anticipated Duration (Months)

17.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer Solid Tumor Advanced Cancer NonHodgkin Lymphoma	Drug: Evorpacept (ALX148) Drug: Pembrolizumab Drug: Trastuzumab Drug: Rituximab Drug: Ramucirumab + Paclitaxel Drug: 5-FU + Cisplatin	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 3, 2017

Actual Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evorpacept (ALX148) The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.	Drug: Evorpacept (ALX148) Evorpacept (ALX148)
Experimental: Evorpacept (ALX148) + Pembrolizumab 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) Evorpacept (ALX148) Drug: Pembrolizumab Keytruda
Experimental: Evorpacept (ALX148) + Trastuzumab 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) Evorpacept (ALX148) Drug: Trastuzumab Herceptin
Experimental: Evorpacept (ALX148) + Rituximab 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) Evorpacept (ALX148) Drug: Rituximab Rituxan
Experimental: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum 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) Evorpacept (ALX148) Drug: Pembrolizumab Keytruda Drug: 5-FU + Cisplatin Standard of care chemotherapy
Experimental: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel 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) Evorpacept (ALX148) Drug: Trastuzumab Herceptin Drug: Ramucirumab + Paclitaxel Standard of care chemotherapy

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicities (Number of participants with a DLT) [Up to 28 days]
Number of participants with a DLT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Denver	Colorado	United States	80045
2	Yale University	New Haven	Connecticut	United States	06520
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	START-Midwest	Grand Rapids	Michigan	United States	49503
6	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
7	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
8	Samsung Medical Center	Seoul		Korea, Republic of
9	Seoul National University Hospital	Seoul		Korea, Republic of
10	Severance Hospital, Yonsei University	Seoul		Korea, Republic of