Safety of AM-928 Infusion in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

This is a Phase I, open-label, dose-escalation study for a novel cancer treatment, AM-928, intravenous infusion antibody for advanced solid tumor. The study is aimed to learn the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of AM-928. The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. Seven dose levels are designed and each participant will be assigned to a specific dose regimen depending on the time of enrollment. In the study, each participant will receive AM-928 treatment cycles till meeting any treatment discontinuation criterion and be followed for safety and long-term survival. The whole study is expected to take approximately three years to complete.

Key facts

Study ID

NCT05687682

Run by

AcadeMab Biomedical Inc.

People needed

38

Starts

2023-07-14

Expected to finish

2026-12-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 18 years
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to or intolerant of existing standard therapy, for which no effective standard therapy that confers clinical benefit is available
• Availability of archival tissue specimens for EpCAM immunohistochemistry (IHC) staining. Tumor tissues acceptable include:
• Tumor tissue sample collected at the time of initial diagnosis
• The most recent available recurrent/metastatic tumor biopsy tissue if available (a pre-treatment biopsy is encouraged if the biopsy site is safely accessible) Note: this criterion is fulfilled if there is a qualified tumor sample (tumor cells were presented in the tumor biopsy tissue), and the tumor tissue slides can be obtained for IHC staining. It is not violated even if the staining result from biopsy obtained after the screening visit reveals that the slides contain no identifiable tumor cells.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• Subject's life expectancy of at least 12 weeks
• Has adequate hematopoietic, coagulation, hepatic function and renal function:
• Hemoglobin ≥ 8.0 g/dL without transfusion or erythropoiesis stimulating agent support within 1 week
• Absolute neutrophil count (ANC) ≥ 1,500 cells/μL without WBC growth factor support within 1 week
• Total white blood cell (WBC) ≥ 2,500 cells/μL
• Platelet ≥ 80,000 counts/μL without transfusion support within 1 week
• International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 upper limit of normal (ULN)
• Total bilirubin ≤ 1.5× ULN and no sign of jaundice (≤ 3× ULN for subjects with known Gilbert disease)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤ 5× ULN for subjects with tumor involvement in liver)
• Serum albumin ≥ 3.0 g/dL
• eGFR (CKD-EPI) ≥ 60 mL/min/1.73 m\^2
• A female subject with childbearing potential should be confirmed of not being pregnant or not lactating at the screening and during the study
• Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement
• Is able to understand the nature of this study and accepts to enter the study by signing written informed consent

You may not qualify if…

• Received any localized cancer therapeutic modalities (e.g., surgery on target lesions, radiotherapy) within 4 weeks prior to initial dosing (except the palliative radiotherapy performed on non-target local lesions), or have any unrecovered surgical wound (except the wound from the biopsy at screening)
• Received anti-tumor therapies such as chemotherapy, small molecular targeted therapy, hormone therapy, biological product therapy (mAbs, bispecific antibody, and ADC), or other anti-cancer agents within 2 weeks or 5 half-lives (whichever is shorter) before the first AM-928 dosing; received immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first AM-928 dosing.
• Carries history of primary malignancy other than the entry diagnosis that could affect compliance with the protocol or interpretation of results within 3 years prior to the Screening Visit, except curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors
• Received immunosuppressive medication(s) (including, but not limited to, steroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, tumor necrosis factor-ɑ antagonists, and calcineurin inhibitors) within 2 weeks (for those half-life ≤ 72 hours) or 4 weeks (for those half-life > 72 hours) prior to study dosing and during the study period, with the following caveats:
• For steroids, ≤10 mg of prednisone per day or equivalent is allowed
• Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed. For a subject under long-term treatment of a concurrent disease/status, the dose should be stable (i.e., no change or decreasing dose) within 3 months prior to C1D1
• The use of inhaled corticosteroids is allowed if they are on a stable dose (i.e., no change or decreasing dose within 3 months prior to C1D1)
• The use of oral mineralocorticoids is allowed
• Physiologic doses of corticosteroids for adrenal insufficiency or supportive care for a subject's advanced tumor may be allowed at the investigator's discretion
• Subject with significant cardiopulmonary abnormalities as defined by:
• Poorly controlled hypertension (systolic blood pressure > 150 mm-Hg and/or diastolic blood pressure > 100 mm-Hg on anti-hypersensitive medications)
• Left ventricular ejection fraction (LVEF) < 50% at screening
• History of symptomatic congestive heart failure > class 2 per New York Heart Association (NYHA) classification
• History of myocarditis
• Myocardial ischemia/infarction or unstable angina within 6 months of study enrollment
• Uncontrolled serious cardiac arrhythmias
• Corrected QT interval > 470 ms demonstrated by at least 2 ECGs > 30 minutes apart
• Evidence of active pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or history of idiopathic pulmonary fibrosis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• History of 2nd or 3rd-degree atrioventricular conduction defects
• History of thromboembolic or cerebrovascular events within the last 6 months at screening, including transient ischemic attack, cerebrovascular accident, or deep vein thrombosis
• Prior treatment with any EpCAM-targeted anti-cancer therapies
• Subjects with the following infections:
• History of active pulmonary tuberculosis infection ≤ 48 weeks prior to C1D1, regardless of treatment
• Any major episode of infection requiring treatment with systemic antibiotics or hospitalization within 2 weeks prior to C1D1
• Known human immunodeficiency virus (HIV) history

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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