Clinical Trials List
Protocol NumberABU001
Active
2024-06-01 - 2027-12-31
Phase I
Recruiting3
A Phase 1, First-in-Human, Open-label, Dose- escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141 in Subjects with Advanced Solid Tumors
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
Ascendo Biotechnology Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Shang-Hung Chen Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Yu-Fang Huang Division of Obstetrics & Gynecology
- Shang-Yin Wu Division of Hematology & Oncology
- 黃盈慈 Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
- 吳珮瑩 Division of Obstetrics & Gynecology
- Chun-Hui Lee Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Peng-Chan Lin Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- 蘇勇曄 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen-Yuan Lin Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- 王秀慈 Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
Dose-escalation
Primary Objective:
The primary objective of is to evaluate the safety and tolerability of ASD141 injection and to
determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) and
recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.
Secondary objectives:
⚫ Characterize the pharmacokinetic (PK) profile of ASD141
⚫ Characterize the immunogenicity of ASD141
⚫ Evaluate the preliminary efficacy or biomarkers of ASD141 in subjects with advanced
solid tumors
Test Drug
injection
Active Ingredient
ASD141
Dosage Form
270
Dosage
110 mg/5ml
Endpoints
Primary Endpoints:
⚫ Frequency of dose-limiting toxicity (DLT) at each dose level
⚫ Frequency, type, severity, and relationship to ASD141 of adverse events (AEs)
Secondary Endpoints:
⚫ Drug exposure and pharmacokinetic parameters of ASD141 derived from serum
concentration-time curves
⚫ Presence or absence of anti-drug antibodies (ADAs) against ASD141
⚫ ORR, PFS, DCR, and DoR
⚫ Frequency of dose-limiting toxicity (DLT) at each dose level
⚫ Frequency, type, severity, and relationship to ASD141 of adverse events (AEs)
Secondary Endpoints:
⚫ Drug exposure and pharmacokinetic parameters of ASD141 derived from serum
concentration-time curves
⚫ Presence or absence of anti-drug antibodies (ADAs) against ASD141
⚫ ORR, PFS, DCR, and DoR
Inclution Criteria
Subjects must meet all of the following criteria to be eligible for the study.
1. Subject has voluntarily agreed to participate by giving written informed consent.
2. Male or female ≥ 18 years of age on the day of signing informed consent.
3. Has a histologically or cytologically confirmed metastatic solid tumor for which there is
no available therapy that is expected to convey clinical benefit.
4. Has at least one measurable lesion by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1.
5. Subjects must have a performance status of ≤ 1 on the ECOG performance scale.
6. Subjects must have adequate organ function as indicated by the following laboratory
values.
1. Subject has voluntarily agreed to participate by giving written informed consent.
2. Male or female ≥ 18 years of age on the day of signing informed consent.
3. Has a histologically or cytologically confirmed metastatic solid tumor for which there is
no available therapy that is expected to convey clinical benefit.
4. Has at least one measurable lesion by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1.
5. Subjects must have a performance status of ≤ 1 on the ECOG performance scale.
6. Subjects must have adequate organ function as indicated by the following laboratory
values.
Exclusion Criteria
Subjects with any of the following will be excluded from the study.
1. Has had curative radiotherapy, investigational or approved cancer therapy (e.g.,
chemotherapy, biologics, hormone [e.g., tamoxifen, leuprolide]) within 2 weeks or 5 half-
lives (whichever is shorter) prior to the first dose of study treatment.
2. 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.
3. Has used an investigational device or has had major surgery within 4 weeks prior to the
first dose of study treatment.
4. Has received previous treatment with another agent targeting the CD11b receptor.
5. Is expected to require any other forms of antineoplastic therapy while participating in the
study.
6. Is on chronic systemic steroid therapy in excess of replacement doses or on any other
form of immunosuppressive medication.
7. 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.
8. 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.
9. Has an active autoimmune disease.
10. Has an acute active infection requiring systemic treatment.
11. Has interstitial lung disease.
12. Has active or a history of non-infectious pneumonitis requiring steroids.
13. Has symptomatic ascites or pleural effusion.
14. Has previously had a hematopoietic stem cell transplant or solid organ transplant.
15. 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. For subjects with HBV DNA
2000 IU/mL who are not on antiviral therapy, a gastroenterologist must be consulted
regarding the use of prophylactic antiviral drugs.
16. Has received a live-virus vaccine within 4 weeks prior to the first dose of study treatment.
17. Has received an mRNA vaccine within 4 months prior to the first dose of study treatment.
18. 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.
1. Has had curative radiotherapy, investigational or approved cancer therapy (e.g.,
chemotherapy, biologics, hormone [e.g., tamoxifen, leuprolide]) within 2 weeks or 5 half-
lives (whichever is shorter) prior to the first dose of study treatment.
2. 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.
3. Has used an investigational device or has had major surgery within 4 weeks prior to the
first dose of study treatment.
4. Has received previous treatment with another agent targeting the CD11b receptor.
5. Is expected to require any other forms of antineoplastic therapy while participating in the
study.
6. Is on chronic systemic steroid therapy in excess of replacement doses or on any other
form of immunosuppressive medication.
7. 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.
8. 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.
9. Has an active autoimmune disease.
10. Has an acute active infection requiring systemic treatment.
11. Has interstitial lung disease.
12. Has active or a history of non-infectious pneumonitis requiring steroids.
13. Has symptomatic ascites or pleural effusion.
14. Has previously had a hematopoietic stem cell transplant or solid organ transplant.
15. 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. For subjects with HBV DNA
2000 IU/mL who are not on antiviral therapy, a gastroenterologist must be consulted
regarding the use of prophylactic antiviral drugs.
16. Has received a live-virus vaccine within 4 weeks prior to the first dose of study treatment.
17. Has received an mRNA vaccine within 4 months prior to the first dose of study treatment.
18. 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.
The Estimated Number of Participants
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Taiwan
67 participants
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Global
67 participants
