Advanced Solid TumorPhase 1NCT05687682
Safety of AM-928 Infusion in Advanced Solid Tumors
A Phase 1 study testing AM-928 in people with Advanced Solid Tumor, run by AcadeMab Biomedical Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AM-928
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2023to Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Presence of hepatitis B surface antigen (HBsAg) with HBV viral load > 2000 IU/mL (HBsAg-positive subjects with HBV viral load ≤ 2000 IU/mL are eligible. These subjects should continue to receive antiviral treatment during the study treatment and follow local HBV antiviral treatment standards after the study treatment during the study)
- HCV RNA positive (subjects with a history of HCV infection are eligible if their HCV viral load cannot be detected at screening; curative antiviral therapy should have been completed at least 4 weeks before C1D1)
- Administration of a live, attenuated vaccine within 4 weeks before C1D1 or anticipation that such a live, attenuated vaccine will be required during the study
- Received any investigational product within 4 weeks before C1D1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies
- Known hypersensitivity to any of the components of AM-928
- Has unstable/uncontrolled central nervous system (CNS) malignancy, leptomeningeal, or brain metastasis (progressing or those who continue to require glucocorticoids or intrathecal chemotherapy)
- Has symptomatic pleural effusion, pericardial effusion, or poorly controlled ascites
- Suffering from side/toxic effects of previous or current therapy [i.e., National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE) ≥ Grade 2] that, judged by the investigator, may interfere with the trial results or the subject's safety
- Prior allogeneic stem cell, solid organ, or bone marrow transplantation
- Subject with any underlying medical, mental, or psychological conditions that would impair the treatment compliance, contraindicate the use of the investigational product, or that may render the subject at high risk from treatment complications, in the opinion of the investigator, would not permit to participate in the study
- All male subjects and female subjects with childbearing potential (between puberty and 1 year after menopause) should use at least one of the appropriate contraception methods shown below from signing ICF to at least 4 months or 5 half-lives (if data available), whichever is longer, after stopping study treatment.
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
- d.1. Use oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception.
- d.2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AM-928 Infusion in Subjects With Advanced Solid Tumors
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.
Read the detailed description
This is a first-in-human Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of AM-928 infusion in subjects with advanced solid tumors in multiple sites in Taiwan.
Eligible subjects will be dosed with different dosages of AM-928 in 1 of the 7 dose levels (0.1, 0.3, 1, 3, 6, 10, 15 mg/kg). Dose levels will be escalated from dose Level 1 at 0.3 mg/kg to Level 6 at 15 mg/kg of AM-928 (or may be de-escalated to Level -1 at 0.1 mg/kg), which will be administered (intravenous infusion) once weekly (QW) for 4 weeks (D1, D8, D15, D22) as a treatment cycle until any treatment discontinuation criterion is met. Basically, there will be no breaks between dosing cycles. From Cycle 4, intra-subject dose escalation may be applied if supported by preliminary safety and PK data.
The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. The accelerated titration will be adopted for 0.3 mg/kg, while the BOIN design will be adopted for other dose levels, including 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, and 15 mg/kg. In the "accelerated titration" stage, if any ≥ Grade 2 adverse event occurs, the current and subsequent dose groups will be changed to the BOIN dose escalation method. The target toxicity rate for the maximum tolerated dose (MTD) is ϕ= 0.3, and the maximum sample size is determined to be 30, maximum of 9 subjects per dose level. A cohort size of 3 and a maximum cohort number of 3 for each dose level will be adopted for subject recruitment. The dose escalation may end when one of the following criteria is met: (1) The planned sample size of 30 has been reached; (2) 9 subjects have been treated and evaluable for DLT at the next intended dose level (should not exceed 9 subjects at one dose level); (3) all doses explored appear to be overly toxic, and the MTD cannot be determined.
The Scientific Review Committee (SRC) will review the safety and/or efficacy data at the end of each dose level cohort for escalation or de-escalation decision (when the DLT rate indicates staying at the current dose, the review process may be waived). Besides, an emergency meeting will be held if the SRC has any safety concerns. A final review process is scheduled at the end of dose escalation for MTD determination. The dose with the toxicity rate closest to the target toxicity rate (ϕ= 0.3) will be selected as MTD.
If the SRC determines that the safety profile of a specific dose level is unfavorable for subjects, the SRC may eliminate that dose level even if the toxicity rate is below 0.3. In this case, the subsequent subjects will be enrolled into the lower dose level(s) following the BOIN design and the lower dose level with the toxicity rate closest to the target toxicity rate (ϕ= 0.3) will be selected as MTD.
- Conditions
- Advanced Solid Tumor
- Being tested
- AM-928
- Keywords
- Solid tumor, EpCAM, Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM-928Biological
AM-928, which is a humanized anti-EpCAM monoclonal antibody developed by AcadeMab Biomedical Inc.
| Study group | Role | What they receive |
|---|---|---|
| Level -1 | Experimental | 0.1 mg/kg Receives: Biological: AM-928 |
| Level 1 | Experimental | 0.3 mg/kg (Starting Dose) Receives: Biological: AM-928 |
| Level 2 | Experimental | 1 mg/kg Receives: Biological: AM-928 |
| Level 3 | Experimental | 3 mg/kg Receives: Biological: AM-928 |
| Level 4 | Experimental | 6 mg/kg Receives: Biological: AM-928 |
| Level 5 | Experimental | 10 mg/kg Receives: Biological: AM-928 |
| Level 6 | Experimental | 15 mg/kg Receives: Biological: AM-928 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD)
The MTD is defined the highest dose level that is closely to the toxicity rated defined in the study.
Measured: 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.
Measured: Up to 29 days
Secondary outcomes (27)
Number of participants with abnormalities in Laboratory Values
Number of participants with abnormal hematology (RBC, WBC with differentials (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), platelet count, hemoglobin, and hematocrit), biochemistry (Albumin, total cholesterol, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), AST, ALT, gamma-glutamyl transferase (γ-GT), total protein, blood urea nitrogen (BUN), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine, estimated glomerular filtration rate (eGFR; 2021 CKD-EPI), triglyceride, amylase, lipase, glucose, uric acid, bicarbonate, calcium, chloride, inorganic phosphorus, iron, magnesium, potassium, and sodium), coagulation (prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR)), urinalysis (specific gravity, pH, occult blood, leukocytes, glucose, protein, ketones, bilirubin, and urine sediment (RBC, WBC, casts, epithelial cells, crystal, and microorganism)), and Troponin-T results
Measured: Up to 28 days after the last dose
Number of treatment-emergent adverse events (TEAEs)
The TEAE is defined as adverse event (AE) occurred after the study drug administration. All TEAE will be assessed for severity by the investigator based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: Up to 28 days after the last dose
Incidence of subjects experiencing treatment-related AE with ≥ Grade 3
The TEAE is defined as adverse event (AE) occurred after the study drug administration. All TEAE will be assessed for severity by the investigator based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: Up to 28 days after the last dose
Incidence of subjects experiencing infusion-related reaction
The infusion-related reaction is adverse reaction due to study drug and occurred during an infusion and for 2 hours after the infusion completes. The symptom includes but not limited to fever, hypotension, hypertension, rash, nausea, dizziness.
Measured: Day 1, Day 8, Day 15, Day 22 of Cycle 1 treatment
Incidence of all-grade and Grade 3-4 laboratory abnormalities
The grading of the laboratory abnormalities is assessed based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: Up to 28 days after the last dose
Percentage of subjects tolerated at least 75% of the intended dose per cycle
A subject will be treated weakly, 4 doses in a cycle
Measured: Up to 3 months
Number of participants with physical abnormalities
Physical examination includes the following items: general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems if applicable for describing the status of the subject's health.
Measured: Up to 3 months
Number of participants with chest x-ray abnormalities
The chest x-ray will be evaluated by the investigators and noted as "normal", "NCS" or "CS".
Measured: Up to 3 months
Number of participants with abnormalities in vital signs
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate, body temperature, and oxygen saturation (SpO2).
Measured: Up to 28 days after the last dose
Number of participants with abnormalities in 12-lead electrocardiogram (ECG) for each post-treatment evaluation until the end of Cycle 3
The results of ventricular rate, PR interval, QRS interval, QT interval, and QTc interval will be recorded.
Measured: Up to 3 months
AM-928 serum concentration
The serum concentration of AM-928
Measured: Day 1, 2, 3, 4, 8 and 15 of Cycle 1 treatment, Day 1 and 15 of Cycle 2, Day 1 of the following Cycle 3 and Cycle 5, and in 7 days after the last dose
AM-928 Pharmacokinetic Parameter - Cmax
The peak post-dose concentration
Measured: Week 1
AM-928 Pharmacokinetic Parameter - Tmax
Time at which Cmax is observed
Measured: Week 1
AM-928 Pharmacokinetic Parameter - T 1/2
Terminal phase elimination half-life
Measured: Week 1
AM-928 Pharmacokinetic Parameter - AUC last
Area under the serum concentration-time profile (AUC) from time zero (T0) to the time of the last quantifiable concentration
Measured: Week 1
AM-928 Pharmacokinetic Parameter - AUC 0-infinity
AUC from T0 extrapolated to infinite time
Measured: Week 1
AM-928 Pharmacokinetic Parameter - CL
The volume of serum cleared of the drug per unit time.
Measured: Week 1
AM-928 Pharmacokinetic Parameter - Vz
Volume of distribution
Measured: Week 1
AM-928 Pharmacokinetic Parameter - Vss
Steady-state volume of distribution
Measured: Week 1
AM-928 Pharmacokinetic Parameter - MRT
Mean Residence Time
Measured: Week 1
AM-928 Pharmacokinetic Parameter - C trough
The last pre-dose concentration at steady state before the next dose is administered
Measured: Day 8, Day 15, Day 22 of Cycle 1 treatment; Day 1, Day 15 of Cycle 2; Day 1 of Cycle 3 and Cycle 5
Objective response rate (ORR)
The proportion of treated subjects achieving the best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1
Measured: 6 months
Change in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 score
The EORTC QLQ-C30 is a patient-reported outcome (PRO) questionnaire to assess the quality of life of cancer patients. Version 3.0 will be applied.
Measured: Up to 28 days after the last dose
Change in Eastern Cooperative Oncology Group (ECOG) score
ECOG- Eastern Cooperative Oncology Group performance status is a scale used to assess how the disease affects the daily living abilities, and determine appropriate treatment and prognosis. It is a simple measure of functional status that determines ability of patient to tolerate therapies in cancer
Measured: Up to 28 days after the last dose
AM-928 Pharmacokinetic Parameter - AUC 0-t
Area under the curve from time zero to a fixed, pre-specified time point (t).
Measured: 1 week
AM-928 Pharmacokinetic Parameter - AUC ratio
AUC ratio (AUClast / AUC0-∞) is added to determine if the sampling schedule was long enough to capture the drug's full profile.
Measured: 1 week
Disease Control Rate (DCR)
The proportion of treated subjects having achieved CR + PR + Stable Disease (SD) per RECIST 1.1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start14 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- AM-928
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AcadeMab Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pi-Chun Li, Ph.D., Study director, AcadeMab Biomedical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687682
- Sponsor's protocol ID
- A928-CLN-001
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AM-928 Infusion in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05687682
- Acronym / sponsor ID
- A928-CLN-001
- Conditions
- Advanced Solid Tumor
- Keywords
- Solid tumor, EpCAM, Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- AcadeMab Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of AM-928 infusion in subjects with advanced solid tumors in multiple sites in Taiwan.
Eligible subjects will be dosed with different dosages of AM-928 in 1 of the 7 dose levels (0.1, 0.3, 1, 3, 6, 10, 15 mg/kg). Dose levels will be escalated from dose Level 1 at 0.3 mg/kg to Level 6 at 15 mg/kg of AM-928 (or may be de-escalated to Level -1 at 0.1 mg/kg), which will be administered (intravenous infusion) once weekly (QW) for 4 weeks (D1, D8, D15, D22) as a treatment cycle until any treatment discontinuation criterion is met. Basically, there will be no breaks between dosing cycles. From Cycle 4, intra-subject dose escalation may be applied if supported by preliminary safety and PK data.
The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. The accelerated titration will be adopted for 0.3 mg/kg, while the BOIN design will be adopted for other dose levels, including 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, and 15 mg/kg. In the "accelerated titration" stage, if any ≥ Grade 2 adverse event occurs, the current and subsequent dose groups will be changed to the BOIN dose escalation method. The target toxicity rate for the maximum tolerated dose (MTD) is ϕ= 0.3, and the maximum sample size is determined to be 30, maximum of 9 subjects per dose level. A cohort size of 3 and a maximum cohort number of 3 for each dose level will be adopted for subject recruitment. The dose escalation may end when one of the following criteria is met: (1) The planned sample size of 30 has been reached; (2) 9 subjects have been treated and evaluable for DLT at the next intended dose level (should not exceed 9 subjects at one dose level); (3) all doses explored appear to be overly toxic, and the MTD cannot be determined.
The Scientific Review Committee (SRC) will review the safety and/or efficacy data at the end of each dose level cohort for escalation or de-escalation decision (when the DLT rate indicates staying at the current dose, the review process may be waived). Besides, an emergency meeting will be held if the SRC has any safety concerns. A final review process is scheduled at the end of dose escalation for MTD determination. The dose with the toxicity rate closest to the target toxicity rate (ϕ= 0.3) will be selected as MTD.
If the SRC determines that the safety profile of a specific dose level is unfavorable for subjects, the SRC may eliminate that dose level even if the toxicity rate is below 0.3. In this case, the subsequent subjects will be enrolled into the lower dose level(s) following the BOIN design and the lower dose level with the toxicity rate closest to the target toxicity rate (ϕ= 0.3) will be selected as MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- AM-928
| Arm | Type | Receives |
|---|---|---|
| Level -1 | Experimental | Biological: AM-9280.1 mg/kg |
| Level 1 | Experimental | Biological: AM-9280.3 mg/kg (Starting Dose) |
| Level 2 | Experimental | Biological: AM-9281 mg/kg |
| Level 3 | Experimental | Biological: AM-9283 mg/kg |
| Level 4 | Experimental | Biological: AM-9286 mg/kg |
| Level 5 | Experimental | Biological: AM-92810 mg/kg |
| Level 6 | Experimental | Biological: AM-92815 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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
Key exclusion criteria (43 listed)
- 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:
- Subject with significant cardiopulmonary abnormalities as defined by:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AM-928AM-928, which is a humanized anti-EpCAM monoclonal antibody developed by AcadeMab Biomedical Inc. | Biological | Level -1, Level 1, Level 2, Level 3, Level 4, Level 5, Level 6 |
Primary outcome
The maximum tolerated dose (MTD)
Time frame: Up to 29 days
The MTD is defined the highest dose level that is closely to the toxicity rated defined in the study.
The incidence of dose-limiting toxicity (DLT)
Time frame: Up to 29 days
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.
27 secondary outcomes
Number of participants with abnormalities in Laboratory Values
Time frame: Up to 28 days after the last dose
Number of treatment-emergent adverse events (TEAEs)
Time frame: Up to 28 days after the last dose
Incidence of subjects experiencing treatment-related AE with ≥ Grade 3
Time frame: Up to 28 days after the last dose
Incidence of subjects experiencing infusion-related reaction
Time frame: Day 1, Day 8, Day 15, Day 22 of Cycle 1 treatment
Incidence of all-grade and Grade 3-4 laboratory abnormalities
Time frame: Up to 28 days after the last dose
Percentage of subjects tolerated at least 75% of the intended dose per cycle
Time frame: Up to 3 months
Number of participants with physical abnormalities
Time frame: Up to 3 months
Number of participants with chest x-ray abnormalities
Time frame: Up to 3 months
Number of participants with abnormalities in vital signs
Time frame: Up to 28 days after the last dose
Number of participants with abnormalities in 12-lead electrocardiogram (ECG) for each post-treatment evaluation until the end of Cycle 3
Time frame: Up to 3 months
AM-928 serum concentration
Time frame: Day 1, 2, 3, 4, 8 and 15 of Cycle 1 treatment, Day 1 and 15 of Cycle 2, Day 1 of the following Cycle 3 and Cycle 5, and in 7 days after the last dose
AM-928 Pharmacokinetic Parameter - Cmax
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - Tmax
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - T 1/2
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - AUC last
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - AUC 0-infinity
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - CL
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - Vz
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - Vss
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - MRT
Time frame: Week 1
AM-928 Pharmacokinetic Parameter - C trough
Time frame: Day 8, Day 15, Day 22 of Cycle 1 treatment; Day 1, Day 15 of Cycle 2; Day 1 of Cycle 3 and Cycle 5
Objective response rate (ORR)
Time frame: 6 months
Change in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 score
Time frame: Up to 28 days after the last dose
Change in Eastern Cooperative Oncology Group (ECOG) score
Time frame: Up to 28 days after the last dose
AM-928 Pharmacokinetic Parameter - AUC 0-t
Time frame: 1 week
AM-928 Pharmacokinetic Parameter - AUC ratio
Time frame: 1 week
Disease Control Rate (DCR)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pi-Chun Li, Ph.D. study director
AcadeMab Biomedical Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AM-928 in people with Advanced Solid Tumor, run by AcadeMab Biomedical Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pi-Chun Li, Ph.D. (+886 27891212 ext. 800, pichun.li@academab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) (time frame: Up to 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.