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

Conditions

Metastatic Cancer, Solid Tumor, Advanced Cancer, NonHodgkin Lymphoma

Keywords

Neoplasms, CD47, SIRPα, ALX148, Evorpacept

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.

Tae Min Kim, Nehal J. Lakhani, Jacob D. Soumerai, Manali Kamdar, Justin F. Gainor et al. (14 authors)

Haematologica2025-04-104 citations

10.3324/haematol.2024.286208

Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study.

Lakhani NJ, Chow LQM, Gainor JF, LoRusso P, Lee KW, Chung HC, Lee J, Bang YJ, Hodi FS, Kim WS, Santana-Davila R, Fanning P, Squifflet P, Jin F, Kuo TC, Wan HI, Pons J, Randolph SS, Messersmith WA.

2021-11-1594 citations

10.1016/s1470-2045(21)00584-2

498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01

Keun-Wook Lee, Hyun Cheol Chung, Tae Min Kim, Nehal J. Lakhani, Wells A. Messersmith et al. (18 authors)

Regular and Young Investigator Award Abstracts2021-11-018 citations

10.1136/jitc-2021-sitc2021.498

404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC)

Keun-Wook Lee, Hyun Cheol Chung, Won Seog Kim, Laura Q.M. Chow, Nehal J. Lakhani et al. (16 authors)

Regular and Young Investigator Award Abstracts2020-11-011 citations

10.1136/jitc-2020-sitc2020.0404

A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy.

Laura Q.M. Chow, Justin F. Gainor, Nehal J. Lakhani, Keun Wook Lee, Hyun Cheol Chung et al. (18 authors)

Journal of Clinical Oncology2020-05-2019 citations

10.1200/jco.2020.38.15_suppl.3056

A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma

Tae Min Kim, Nehal J. Lakhani, Justin F. Gainor, Manali Kamdar, Philip Fanning et al. (11 authors)

Blood2019-11-1325 citations

10.1182/blood-2019-123219

A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy.

Laura Q.M. Chow, Justin F. Gainor, Nehal J. Lakhani, Hyun Cheol Chung, Keun‐Wook Lee et al. (16 authors)

Journal of Clinical Oncology2019-05-2018 citations

10.1200/jco.2019.37.15_suppl.2514

A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma.

Nehal J. Lakhani, Patricia LoRusso, Navid Hafez, Anuradha Krishnamurthy, Timothy J. O’Rourke et al. (13 authors)

Journal of Clinical Oncology2018-05-2020 citations

10.1200/jco.2018.36.15_suppl.3068

ALX148 Is a High Affinity Sirpα Fusion Protein That Blocks CD47, Enhances the Activity of Anti-Cancer Antibodies and Checkpoint Inhibitors, and Has a Favorable Safety Profile in Preclinical Models

Steven E. Kauder, Tracy C. Kuo, Amy Chen, Ons Harrabi, Sony Sotelo Rocha et al. (13 authors)

Blood2017-12-078 citations

10.1182/blood.v130.suppl_1.112.112

Interventions

DRUGEvorpacept (ALX148)

Evorpacept (ALX148)

DRUGPembrolizumab

Keytruda

DRUGTrastuzumab

Herceptin

DRUGRituximab

Rituxan

DRUGRamucirumab + Paclitaxel

Standard of care chemotherapy

DRUG5-FU + Cisplatin

Standard of care chemotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Countries

South Korea, United States

Outcome results

None listed