Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.

pembrolizumab 200 mg IV given every 3 weeks.

evorpacept

pembrolizumab

Harry Liu, MD, MPH, MBA

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Merck Sharp & Dohme LLC

ALX Oncology Inc.

Infections

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Papilloma

Virus Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Stereotactic radiation therapy (SBRT (8GyX3)) will be delivered to gross tumor volume (GTV) +3mm, followed by Pembrolizumab 200 mg IV and Evorpacept 45 mg/kg IV every three weeks x 2 cycles followed by surgical resection of primary tumor and neck dissection.

After stereotactic radiation to primary tumor and neck on week 1 of study, Evorpacept 45 mg/kg is administered by IV infusion every three weeks starting on Week 2, Day 1 of study for a total two 21-day cycles (6 weeks)

Evorpacept

Joseph A Califano, MD

Jospeh A Califano, MD

The majority of head and neck cancer patients do not respond to immunotherapies, and clinical responses are often not durable. However, targeting tumors with stereotactic radiation in combination with immunotherapy while sparing draining lymphatics enhances anticancer immunity, resulting in dramatic response in HPV (Human Papilloma Virus) virus related cancers of the throat. This trial will leverage targeted tumor radiation and immunotherapy in advance of standard surgical therapy to improve the response of HPV (Human Papilloma Virus) throat cancer to radiation and immunotherapy.

This is a prospective, multi-center, open-label, one-arm, two-stage, Phase II study to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) in patients with stage I HPVOPC (Human Papilloma Virus Oropharynx Cancer) amenable to surgical resection, including AJCC (American Joint Committee on Cancer) VIII T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer) and excluding patients with solitary lymph nodes less than 3 cm. A Simon's two-stage optimal design is used for this study. We will test the hypothesis that neoadjuvant stereotactic tumor targeting radiation along with CD47 inhibition (evorpacept) and PD-1 inhibition (pembrolizumab) provides pathologic response compared to current standard of care rates of locoregional control.

A phase II clinical trial for AJCC (American Joint Committee on Cancer) VIII Stage I T1-2N1M0 HPVOPC, including patients amenable to surgical resection, excluding patients with solitary lymph nodes less than 3 cm who are amenable to surgical therapy alone. Stereotactic radiation therapy (SBRT (8GyX3)) will be delivered to gross tumor volume (GTV) +3mm, followed by Pembrolizumab 200 mg IV and Evorpacept 45 mg/kg IV every three weeks x 2 cycles followed by surgical resection of primary tumor and neck dissection. The primary endpoint is pathologic response compared to historical standard of care rates of locoregional control, and secondary endpoints are clinical response, survival, and safety and toxicity.

Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)

Neoadjuvant Radiation and Evorpacept (ALX148) in Combination With Pembrolizumab In Patients With Previously Untreated Locally Advanced, Resectable, HPVOPC (Human Papilloma Virus Oropharynx Cancer)

Pathologic response is determined when surgery is performed at week 7-10 of study

Major pathologic response is defined as \<10% viable tumor cells in the resection specimen) after surgical resection

clinical response will be determined by clinical and radiographic criteria by comparison of pretreatment and post-treatment assessment prior to surgery

clinical to pathologic down-staging will be assessed by comparing pretreatment AJCC (American Joint Committee on Cancer) VIII stage to pathologic stage determined by surgical pathology results. And decrease in overall Stage or decrease in T or N category will be defined as down staging.

survival will be determined based on intent to treat analysis at conclusion of study after 3 years

subjects will be assessed for presence of disease after completion of treatment and up to three years

Safety and toxicity will be assessed by CTCAE for overall toxicity and safety and Clavien-Dindo for toxicity related to surgery.

The University of Washington-Quality of Life (UW-QOL) to assess standard penetration-aspiration score (PAS) will be used to assess patient and observer-reported quality of life and functional outcomes.

MD Anderson Dysphagia Inventory (MDADI) to assess standard penetration-aspiration score (PAS) will be used to assess patient and observer-reported quality of life and functional outcomes.

Video Fluoroscopic Swallow Study (VFSS) to assess standard penetration-aspiration score (PAS) will be used to assess patient and observer-reported quality of life and functional outcomes.

Patients will undergo assessment of T-cell infiltration into primary tumors expressed as % staining in primary tumor sections on immunohistochemical staining.

Patients will undergo assessment of frequency of shared tumor and sentinel node T-cell clones as defined by absolute number of shared clones,

Patients will undergo assessment of number of B-cell germinal centers in draining sentinel lymph nodes compared to non-sentinel nodes as defined by average number of B-cell germinal centers per high powered field with random sampling of at least 10 high powered fields on microscopy.

University of California, San Diego

Professor, Department of Otolaryngology-Head and Neck Surgery

Zanidatamab

This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced \[inoperable\] and/or metastatic) human epidermal growth factor receptor 2 (HER2)-expressing cancer.

Part 1 of the study will first evaluate the safety and tolerability and establish the recommended doses (RDs) of zanidatamab in combination with evorpacept (ALX148). Part 2 of the study will evaluate the anti-tumor activity of the combination of zanidatamab plus evorpacept (ALX148) at the RD levels in indication-specific expansion cohorts.

single-arm, open-label, multi-cohort, multi-center study

A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

A Phase 1b/2, 2-part Open-label Study to Assess the Safety and Antitumor Activity of Zanidatamab in Combination With ALX148 in Advanced HER2-expressing Cancer

Number of patients who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to zanidatamab or evorpacept (ALX148), including combination of zanidatamab with evorpacept (ALX148)

Number of patients who experienced AEs, serious adverse events (SAEs), or adverse events of special interest (AESIs)

Number of patients who experienced a Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

Number of patients who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Number of patients who achieved a best response of CR, PR, or stable disease (SD) during treatment per RECIST 1.1

Number of patients who achieved a SD for ≥ 24 weeks or a confirmed BOR of CR or PR during treatment per RECIST 1.1

The time from the first objective response (CR or PR) to documented progressive disease per RECIST 1.1, clinical progression, or death within 30 days of last dose of study drug (zanidatamab and/or evorpacept \[ALX148\]) from any cause

The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause

Number of patients with a PFS time ≥ 24 weeks

The time from first dose of study treatment until death from any cause

Number of patients who experienced AEs, SAEs, or AESIs

Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using NCI-CTCAE, version 5.0

Minimum observed serum concentration (trough)

Jazz Pharmaceuticals

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Transitional Cell Carcinoma

Antibodies

Immunoglobulins

Tubulin Modulators

Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.

Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.

Fusion protein that blocks CD47-SIRPalpha pathway

Nectin-4 directed antibody and microtubule inhibitor conjugate

Enfortumab Vedotin

Haiying (Harry) Liu, MD, MPH, MBA

AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.

A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Trastuzumab

Paclitaxel

Albumin-Bound Paclitaxel

Ramucirumab

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Evorpacept (ALX148)

Philip Fanning, PhD

Sophia Randolph, MD, PhD

Study Coordinator

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.

Phase 2 is Open Label; Phase 3 is blinded

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

Percentage of patients with objective response per RECIST 1.1

Eli Lilly and Company

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Venetoclax

Azacitidine

Antimetabolites

Enzyme Inhibitors

Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine

Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine

venetoclax

azacitidine

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).

The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML.

A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)

Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Phase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle

Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

Number of participants achieving a complete response per International Working Group (IWG) criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)	NCT04675294	Head and Neck C... Head and Neck S...	evorpacept pembrolizumab	18 Years -	ALX Oncology Inc.
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)	NCT05787639	Oropharynx Canc...	Evorpacept	18 Years -	University of California, San Diego
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)	NCT05787639	Oropharynx Canc...	Evorpacept	18 Years -	University of California, San Diego
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer	NCT05027139	HER2-expressing...	Zanidatamab Evorpacept	18 Years -	Jazz Pharmaceuticals
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)	NCT05524545	Bladder Cancer Urothelial Carc...	Evorpacept Enfortumab Vedo...	18 Years -	ALX Oncology Inc.
A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)	NCT05002127	Gastric Cancer Gastroesophagea... Gastric Adenoca...	Evorpacept (ALX... Trastuzumab Ramucirumab Paclitaxel	18 Years -	ALX Oncology Inc.
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)	NCT04755244	Acute Myeloid L... AML, Adult	evorpacept venetoclax azacitidine	18 Years -	ALX Oncology Inc.
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer	NCT05027139	HER2-expressing...	Zanidatamab Evorpacept	18 Years -	Jazz Pharmaceuticals
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)	NCT04755244	Acute Myeloid L... AML, Adult	evorpacept venetoclax azacitidine	18 Years -	ALX Oncology Inc.
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)	NCT05787639	Oropharynx Canc...	Evorpacept	18 Years -	University of California, San Diego
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)	NCT04417517	Higher Risk Mye...	evorpacept azacitidine	18 Years -	ALX Oncology Inc.

Spots Global Cancer Trial Database for evorpacept

Every month we try and update this database with for evorpacept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for evorpacept

Every month we try and update this database with for evorpacept cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for evorpacept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.