Metastatic Solid TumorPhase 1NCT06235437
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141
A Phase 1 study testing ASD141 in people with Metastatic Solid Tumor, run by Ascendo Biotechnology Co., Ltd. at 2 sites in Taiwan.
Trial summary
This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- ASD141
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesTaiwan
- Study dates
- 29 Aug 2024to Dec 2027
- 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
- Subject has voluntarily agreed to participate by giving written informed consent.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Has a histologically or cytologically confirmed metastatic solid tumor for which there is no available therapy that is expected to convey clinical benefit.
- Has at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Subjects must have a performance status of ≤ 1 on the ECOG performance scale.
- Subjects must have adequate organ function as indicated by the following laboratory values. Hematological Neutrophil Count (ANC) ≥ 1,500 /µL (mm3) Platelets ≥ 100,000 /µL (mm3) Hemoglobin ≥ 9 g/dL Renal estimated GFR (non-indexed)* ≥ 50 mL/min Hepatic Serum total bilirubin ≤ 1.5X ULN OR Direct bilirubin ≤ 1.5X ULN for subjects with total bilirubin levels > 1.5 ULN; ≤ 3X ULN for subjects with hepatoma or Gilbert's disease AST and ALT ≤ 2.5X ULN OR ≤ 5X ULN for subjects with active liver metastases and primary hepatoma Coagulation International normalized ratio (INR) ≤ 1.5X ULN Activated partial thromboplastin time (aPTT) ≤ 1.5X ULN
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- QTcF < 480 msec
- Female subject of childbearing potential has a negative serum pregnancy test.
- Female subjects of childbearing potential and male subjects must be willing to use adequate contraceptive methods during the study treatment and for at least 90 days after the last dose of study treatment. Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, diaphragm with spermicide, cervical cap with spermicide, male or female condom with spermicide or a partner who is sterile. Spermicides alone are not an acceptable method of contraception.
- Has provided a tumor tissue sample (latest archival or newly obtained core or excisional biopsy of a tumor lesion).
Who cannot join
- Has had curative radiotherapy, investigational or approved cancer therapy (e.g., chemotherapy, biologics, hormone [e.g., tamoxifen, leuprolide]) within 2 weeks or 5 halflives (whichever is shorter) prior to the first dose of study treatment.
- Has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to previous anti-cancer therapy prior to the first dose of study treatment, with the exception of alopecia and ≤ Grade 2 peripheral neuropathy.
- Has used an investigational device or has had major surgery within 4 weeks prior to the first dose of study treatment.
- Has received previous treatment with another agent targeting the CD11b receptor.
- Is expected to require any other forms of antineoplastic therapy while participating in the study.
- Is on chronic systemic steroid therapy in excess of replacement doses or on any other form of immunosuppressive medication.
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- Has a history of a previous additional malignancy unless potentially curative treatment has been completed with no evidence of malignancy for at least 2 years prior to the first dose of study treatment. Subjects with carcinoma in situ of any origin are eligible.
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with CNS metastases are eligible if they are asymptomatic (including those who have never received any treatment) and not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases.
- Has an active autoimmune disease.
- Has an acute active infection requiring systemic treatment.
- Has interstitial lung disease.
- Has active or a history of non-infectious pneumonitis requiring steroids.
- Has symptomatic ascites or pleural effusion.
- Has previously had a hematopoietic stem cell transplant or solid organ transplant.
- Is known to have active chronic or acute Hepatitis B; however, subjects with HBV DNA
- ≤ 2000 IU/mL with or without antiviral therapy are eligible.
- Has received a live-virus vaccine within 4 weeks prior to the first dose of study treatment.
- Has received an mRNA vaccine within 4 months prior to the first dose of study treatment.
- Has any of the following condition within 3 months of the first dose of study treatment:
- deep vein thrombosis, pulmonary embolism, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
- Has a history of allergic reactions to any of the components of ASD141 Injection (i.e., sodium citrate, sucrose, and polysorbate 80).
- Has a history of severe hypersensitivity or anaphylactic reactions (e.g., shock, asthma etc.).
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Yu-Min Yeh, M.D. PhD., 06-2752037 ext. 3968
Yu-Min Yeh, M.D. PhD.
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chao-Hua Chiu, M.D., 02-2737-2181 ext. 7633
Chao-Hua Chiu, M.D.
About this study
Official title: A Phase 1, First-in-Human, Open-label, Doseescalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141 in Subjects With Advanced Solid Tumors
This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.
Read the detailed description
This is a multicenter, first-in-human (FIH), open-label, non-randomized, dose escalation study of ASD141 to evaluate safety, tolerability, and preliminary anti-tumor activity of ASD141 in subjects with advanced solid tumors. The study includes 8 dose cohorts.
- Conditions
- Metastatic Solid Tumor
- Being tested
- ASD141
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD141Biological
Subjects will receive one of 8 dose levels of ASD141.
| Study group | Role | What they receive |
|---|---|---|
| ASD141 | Experimental | IV, Monotherapy Receives: Biological: ASD141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicity
Frequency of dose-limiting toxicity (DLT) at each dose level
Measured: 28 days
Percentage of participants with adverse events (AEs) and serious AEs (SAEs), vital signs, and abnormal laboratory parameters
Frequency, type, severity, and relationship to ASD141 of adverse events (AEs)
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary outcomes (10)
Plasma Cmax
maximum measured concentration of ASD141 in plasma
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUClast
area under the plasma concentration-time curve of ASD141 from hour 0 to last sample with measurable plasma concentrations
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUCinfinity
area under the plasma concentration-time curve of ASD141 in plasma over the time interval from 0 extrapolated to infinity
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma t1/2
terminal half-life of ASD141 in plasma
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma tmax
Time of the maximum observed ASD141 concentration
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
anti-drug antibodies (ADAs)
Presence or absence of anti-drug antibodies (ADAs) against ASD141
Measured: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Objective response rate
Percentage of participants with a confirmed CR or PR according to RECIST v1.1
Measured: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Progressive free survival
The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression
Measured: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Disease control rate
Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment
Measured: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Duration of response
The time from first response according to RECIST v1.1 and iRECIST v1.1 until progression or death in the absence of disease progression
Measured: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Subjects will receive one of 8 dose levels of ASD141 (0.01, 0.03, 0.1, 0.3, 1, 3, 10, and 30 mg/kg) once every week (QW) in a 28-day cycle. BOIN design with accelerated titration
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascendo Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu-Min Yeh, M.D. PhD., Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235437
- Sponsor's protocol ID
- ABU001
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2024
- Last updated
- 7 Jan 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-label, Doseescalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06235437
- Acronym / sponsor ID
- ABU001
- Conditions
- Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Ascendo Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Feb 2024 (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 study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.
Detailed description
This is a multicenter, first-in-human (FIH), open-label, non-randomized, dose escalation study of ASD141 to evaluate safety, tolerability, and preliminary anti-tumor activity of ASD141 in subjects with advanced solid tumors. The study includes 8 dose cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive one of 8 dose levels of ASD141 (0.01, 0.03, 0.1, 0.3, 1, 3, 10, and 30 mg/kg) once every week (QW) in a 28-day cycle. BOIN design with accelerated titration
| Arm | Type | Receives |
|---|---|---|
| ASD141 | Experimental | Biological: ASD141IV, Monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has voluntarily agreed to participate by giving written informed consent.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Has a histologically or cytologically confirmed metastatic solid tumor for which there is no available therapy that is expected to convey clinical benefit.
- Has at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Subjects must have a performance status of ≤ 1 on the ECOG performance scale.
Key exclusion criteria (25 listed)
- Has had curative radiotherapy, investigational or approved cancer therapy (e.g., chemotherapy, biologics, hormone [e.g., tamoxifen, leuprolide]) within 2 weeks or 5 halflives (whichever is shorter) prior to the first dose of study treatment.
- Has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to previous anti-cancer therapy prior to the first dose of study treatment, with the exception of alopecia and ≤ Grade 2 peripheral neuropathy.
- Has used an investigational device or has had major surgery within 4 weeks prior to the first dose of study treatment.
- Has received previous treatment with another agent targeting the CD11b receptor.
- Is expected to require any other forms of antineoplastic therapy while participating in the study.
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 |
|---|---|---|
| ASD141Subjects will receive one of 8 dose levels of ASD141. | Biological | ASD141 |
Primary outcome
dose-limiting toxicity
Time frame: 28 days
Frequency of dose-limiting toxicity (DLT) at each dose level
Percentage of participants with adverse events (AEs) and serious AEs (SAEs), vital signs, and abnormal laboratory parameters
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Frequency, type, severity, and relationship to ASD141 of adverse events (AEs)
10 secondary outcomes
Plasma Cmax
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUClast
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma AUCinfinity
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma t1/2
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Plasma tmax
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
anti-drug antibodies (ADAs)
Time frame: Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Objective response rate
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Progressive free survival
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Disease control rate
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Duration of response
Time frame: Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 2 year)
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 7 Jan 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.
Yu-Min Yeh, M.D. PhD. principal investigator
National Cheng-Kung University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASD141 in people with Metastatic Solid Tumor, run by Ascendo Biotechnology Co., Ltd. at 2 sites 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 10 inclusion and 25 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 I-FANG TSAI, M.S. (+886277288922, ifang.tsai@ascendobiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicity (time frame: 28 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 7 Jan 2026.