Safety of AM-928 Infusion in Advanced Solid Tumors

NCT05687682 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: A928-CLN-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor

Keywords

Solid tumor; EpCAM; Antibody

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD)

  The MTD is defined the highest dose level that is closely to the toxicity rated defined in the study.

  Up to 29 days

• The incidence of dose-limiting toxicity (DLT)

  The DLT is specified treatment-emergent events that occur in cycle 1 treatment period, graded by NCI-CTCAE v5.0, and causality to study drug cannot be clearly ruled out.

  Up to 29 days

Secondary Outcomes (27)

• Number of participants with abnormalities in Laboratory Values

  Up to 28 days after the last dose

• Number of treatment-emergent adverse events (TEAEs)

  Up to 28 days after the last dose

• Incidence of subjects experiencing treatment-related AE with ≥ Grade 3

  Up to 28 days after the last dose

• Incidence of subjects experiencing infusion-related reaction

  Day 1, Day 8, Day 15, Day 22 of Cycle 1 treatment

• Incidence of all-grade and Grade 3-4 laboratory abnormalities

  Up to 28 days after the last dose

Other Outcomes (1)

• An exploratory objective and endpoint for dose-response and exposure-response analyses

  From enrollment to the end of last does to 12 weeks

Study Arms (7)

Level -1

EXPERIMENTAL

0.1 mg/kg

Biological: AM-928

Level 1

EXPERIMENTAL

0.3 mg/kg (Starting Dose)

Biological: AM-928

Level 2

EXPERIMENTAL

1 mg/kg

Biological: AM-928

Level 3

EXPERIMENTAL

3 mg/kg

Biological: AM-928

Level 4

EXPERIMENTAL

6 mg/kg

Biological: AM-928

Level 5

EXPERIMENTAL

10 mg/kg

Biological: AM-928

Level 6

EXPERIMENTAL

15 mg/kg

Biological: AM-928

Interventions

AM-928 BIOLOGICAL

AM-928, which is a humanized anti-EpCAM monoclonal antibody developed by AcadeMab Biomedical Inc.

Level -1; Level 1; Level 2; Level 3; Level 4; Level 5; Level 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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

Sponsors & Collaborators

• AcadeMab Biomedical Inc.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Study Officials

• Pi-Chun Li, Ph.D.

  AcadeMab Biomedical Inc.

  STUDY DIRECTOR

Central Study Contacts

Pi-Chun Li, Ph.D.

CONTACT

+886 27891212; pichun.li@academab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: AM-928

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 18, 2023
• Study Start: July 14, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)