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ALX Oncology Holdings (ALXO)
NASDAQ:ALXO
Alx2004
Head And Neck Cancer, Colo-Rectal Cancer, Hnscc, Esophageal Squamous Cell Carcinoma (Escc), Crc (Colorectal Cancer), Nsclc (Advanced Non-Small Cell Lung Cancer), Escc
Phase I
Recruiting
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Jun 27, 2025
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Gemcitabine, Trastuzumab, Paclitaxel, Capecitabine, Vinorelbine, Eribulin, Evorpacept (Alx148)
Breast Cancer, Metastatic
Phase I/II
Recruiting
ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
May 22, 2025
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Evorpacept, Enfortumab Vedotin
Bladder Cancer, Urothelial Carcinoma
Phase I
Completed
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
Aug 30, 2022
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Azacitidine, Venetoclax, Evorpacept
Acute Myeloid Leukemia, Aml, Adult
Phase I
Terminated
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
Feb 11, 2021
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Pembrolizumab, Evorpacept, Cisplatin/Carboplatin; 5Fu
Head And Neck Squamous Cell Carcinoma, Head And Neck Cancer
Phase II
Active Not Recruiting
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Dec 15, 2020
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Pembrolizumab, Evorpacept
Head And Neck Squamous Cell Carcinoma, Head And Neck Cancer
Phase II
Active Not Recruiting
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Dec 15, 2020
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Azacitidine, Evorpacept
Higher Risk Myelodysplastic Syndromes
Phase I
Terminated
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Jun 02, 2020
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Pembrolizumab, Rituximab, Trastuzumab, Evorpacept (Alx148), Ramucirumab + Paclitaxel, 5-Fu + Cisplatin
Solid Tumor, Advanced Cancer, Metastatic Cancer, Nonhodgkin Lymphoma
Phase I
Completed
A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Dec 15, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does ALX Oncology Holdings (ALXO) have in its pipeline
ALXO is currently developing the following drugs: Alx2004, Gemcitabine, Trastuzumab, Paclitaxel, Capecitabine, Vinorelbine, Eribulin, Evorpacept (Alx148), Evorpacept, Enfortumab Vedotin. These drug candidates are in various stages of clinical development as the company works toward FDA approval.