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.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Infective Agents

Antibodies

Doxorubicin

Liposomal doxorubicin

Immunomodulating Agents

Immunoglobulins

Immunoglobulins, Intravenous

Immunoglobulin Fc Fragments

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Given on Day 1 of each 21 day cycle, in the following order of administration:

200 mg IV pembrolizumab\* (maximum of 2 years (approximately 35 cycles)

45 mg/kg IV ALX148

30 mg/m\^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)\*

\*standard of care

A type of immunotherapy that stimulates the body's immune system to fight cancer cells by targeting and blocking PD-1 proteins on the surface of certain immune T-cells, thus triggering the T-cells to find and kill cancer cells.

A fusion protein comprised of a high affinity CD47 blocker linked to an inactive immunoglobulin Fc region, enhancing innate and adaptive immune responses against cancer.

ALX148

An anthracycline that slows/stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, used as second line non-platinum chemotherapy in patients with platinum-resistant ovarian cancer.

Joshua Plassmeyer

Haider Mahdi, MD

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

All patients on this study will receive Pegylated Liposomal Doxorubicin (PLD) as standard of care combined with pembrolizumab and ALX148 iv every 21 days. Treatment of 45 mg/kg Q3W ALX148 in combination with pembrolizumab + chemotherapy will continue until disease progression or unacceptable grade 3/4 toxicities. For patients with a complete response to therapy, maintenance therapy with pembrolizumab and ALX148 will be continued for 12 months. Patients will have up to 4 weeks of screening, and will be treated until disease progression, patient withdraws consent, unacceptable toxicity occurs, complete response or the study is terminated. Patients may continue treatment after radiographic progression if, in the judgment of the treating investigator the patient is deriving clinical benefit from study treatment by demonstrating an absence of clinical symptoms or signs indicating clinically significant disease progression; no decline in performance status; absence of rapid disease progression or threat to vital organs or critical anatomical sites. A follow-up visit will occur within between 28 days and 35 days after the last treatment.

Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer

Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Patients With Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

The proportion of patients having either a complete response (CR) or partial response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

The number of months from the date of study enrollment until date of death ( from any cause) or last known date of follow up if otherwise lost to follow up.

The number of months from the date of study enrollment to the date of an event of disease progression (per RECIST 1.1) or to the date of death from any cause. Progressive Disease (PD) as defined by RECIST v1.1 for target lesions: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

The proportion of patients with complete or partial response per iRECIST. irCR (Complete Response):Disappearance of non-nodal lesions. All pathologic lymph nodes \<10 mm (2 consecutive measures ≥4 weeks apart); irPR (Partial Response):≥30% decrease from baseline (2 consecutive measures ≥4 weeks apart); All pathologic lymph nodes \<10 mm (Non-Target Lesions: Any other than disappearance of all non-nodal lesions and reduction of pathologic lymph nodes \<10 mm). Baseline tumor burden: sum of single diameters (short axis for nodal lesions, longest diameter for other lesions) for target lesions. In subsequent scans, the diameters of new measurable lesions are added to the tumor burden. Re-treatment: ≤5 target lesions (=/≠ original lesions) are selected and a new baseline tumor burden will be established.

The number of months from the date of study enrollment to the date of disease progression or death in those participants who achieve complete or partial response per RECISIT 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change not a single lesion increase.

ALX Oncology

Haider Mahdi

Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences

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

Tubulin Modulators

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

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

Fusion protein that blocks CD47-SIRPalpha pathway

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

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Amino Acids

Antibodies, Monoclonal

Trastuzumab deruxtecan

Immunoglobulin G

Mitogens

Tyrosine Kinase Inhibitors

Tucatinib

Topoisomerase I Inhibitors

Immunoconjugates

Immunologic Factors

Protein Kinase Inhibitors

Tyrosine

The combination of T-DXd and ALX148 aims to explore the anti-tumoral effects of trastuzumab, of the topoisomerase inhibitor DXd and of the CD47-blocking agent ALX148. The rationale for this combination is that ALX148 is hypothesized, based on preclinical data, to facilitate antibody-dependent cellular phagocytosis (ADCP) of HER2 expressing (\>HER2 1+) breast cancer binding T-DXd while cancer cell intrinsic or bystander cytotoxicity of T-DXd will result in the release of neoantigens promoting immune mediated antitumor activity in the tumor microenvironment.

Zanidatamab is a bispecific IgG1-like antibody directed against two distinct HER2 epitopes. It induces formation of receptor clusters and internalization resulting in downregulation. It also inhibits growth factor-dependent and -independent tumor cell proliferation as well as potently activating ADCC, ADCP, and CDC.

Tucatinib is a highly selective, small molecule tyrosine kinase inhibitor (TKI) of HER2 compared to other TKI's (i.e., EGFR). It is well tolerated, crosses the blood brain barrier and can treat CNS disease. It is FDA approved for HER2+ breast cancer.

Given the promising clinical data for each of these drugs which have different mechanisms, the effect of zanidatamab after T-DXd (Enhertu®) in breast cancer patients, and the favorable toxicity profile of both drugs, we hypothesize that the combination of tucatinib and zanidatamab will be well tolerated and more efficacious than either drug alone for the treatment of patients with HER2 positive breast cancer.

CD47 Inhibitor: A fusion protein containing a high affinity engineered D1 domain of human signal regulatory protein alpha (SIRPα) variant 1 (v1) genetically linked to a modified and inactive Fc domain of human immunoglobulin (Ig) G1.

Antibody-drug conjugate (ADC): A recombinant humanized anti-human HER2 IgG1 monoclonal antibody, conjugated with linker to a Topoisomerase I inhibitor

Fam-Trastuzumab Deruxtecan-Nxki

Bispecific HER2 antibody: A humanized, bispecific, immunoglobulin G isotype 1 (IgG1)-like antibody directed against the juxtamembrane extracellular domain (ECD4) and the dimerization domain (ECD2) of human epidermal growth factor receptor 2 (HER2).

Zanidatamab

Small molecule tyrosine kinase inhibitor (TKI) of HER2 (oral drug).

Smita M Asare

Maria Pitsiouni, PhD

Clara Duarte

Yordanos Tafesse

Nan Chen, MD

Rita Nanda, MD

Katie Vaughn, RN

Jessica Hellmer

David Potter, MD, PhD

Doug Yee, MD

Heather Walker

Julia Moore, RN

Paula Pohlmann, MD, MSc, PhD

Debasish Tripathy, MD

Paula R Pohlmann, MD, MSc, PhD

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The trial allows for various study arm designs, with the goal to complete analysis of a study arm in 12 to 18 months.

This is an open-label, multi-site, multi-arm platform study, where each drug regimen arm may have different study designs and eligibility. In particular, dose finding parts may employ different designs (e.g., 3+3, Bayesian Optimal Interval Design \[BOIN\], continual reassessment method \[CRM\], etc.) for each arm in the PRE-I-SPY program. See each arm for specific study model details.

PRE-I-SPY Phase I/Ib Oncology Platform Program

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

Evaluate the number of adverse events related to the treatment according to the current version of CTCAE during the trial.

To determine the safety and tolerability of new agents/regimens in participants with certain advanced solid tumors and breast cancer. DLT rate (number of participants who experience a protocol defined DLT/total number of DLT cohort participants at that dose).

The maximum dose level (mg/kg) which is not eliminated.

Using all available data, computation of RP2D (mg/kg), which may not be the MTD.

To obtain preliminary efficacy data of the new agents/regimens in participants with certain advanced solid tumors and breast cancer.

To provide descriptive assessment of Progression Free Survival (PFS) of the new agents/regimens with certain advanced solid tumors and breast cancer

To obtain preliminary Clinical Benefit Rate (CBR) at 6 months of participants treated with the new agents/regimens.

QuantumLeap Healthcare Collaborative

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.
Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer	NCT05467670	Ovarian Cancer	Pembrolizumab ALX148 Doxorubicin	18 Years -	University of Pittsburgh
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 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.
PRE-I-SPY Phase I/Ib Oncology Platform Program	NCT05868226	HER2-positive B... Metastatic Canc... Metastatic Brea... Metastatic HER2-positive M... HER2 Mutation-R... HER-2 Protein O... HER2-negative B... Triple Negative... HR Positive Hormone Recepto... Estrogen Recept... Progesterone Re... Hormone Recepto... Solid Tumor Solid Tumor, Ad... Solid Carcinoma HER2 Low Breast... HER2 Low Breast... ER Positive Bre... PR-positive Bre...	ALX148 Fam-Trastuzumab... Zanidatamab Tucatinib	18 Years -	QuantumLeap Healthcare Collaborative
Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer	NCT05467670	Ovarian Cancer	Pembrolizumab ALX148 Doxorubicin	18 Years -	University of Pittsburgh
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 alx148

Every month we try and update this database with for alx148 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 alx148

Every month we try and update this database with for alx148 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 alx148 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.