Clinical Trials List
Protocol NumberABU001
NCT Number(ClinicalTrials.gov Identfier)NCT06235437
Active
2024-06-01 - 2027-12-31
Phase I
Recruiting3
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
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/06/18
Investigators and Locations
Co-Principal Investigator
- 高冠鈞 Division of Hematology & Oncology
- Shang-Fu Hsu Division of Thoracic Medicine
- Huan-Tze Lin Division of Thoracic Medicine
- Jia-Ruey Tsai Division of Thoracic Medicine
- Kai-Ling Lee Division of Thoracic Medicine
- Sheng-Yu Chen Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王秀慈 Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
- Chun-Hui Lee Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Yung-Yeh Su Division of Hematology & Oncology
- Peng-Chan Lin 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
- Chia-Jui Yen Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- Chih-Chieh Yen Division of Hematology & Oncology
- 吳珮瑩 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Solid Tumor
Objectives
Dosage Increment Phase
Primary Objectives:
To evaluate the safety and tolerability of ASD141 injection in patients with advanced solid tumors, establish the maximum tolerated dose (MTD) or optimal biological dose (OBD), and the recommended Phase 2 dose (RP2D) for a Phase 2 trial.
Secondary Objectives:
⚫ Analyze the pharmacokinetic (PK) characteristics of ASD141
⚫ Analyze the immunogenicity of ASD141
⚫ Evaluate the preliminary efficacy or biomarkers of ASD141 in patients with advanced solid tumors
Dose Scalability Phase (Selective Execution)
Primary Objectives:
⚫ Establish the safety and tolerability of ASD141 injection in specific solid tumor patients
⚫ Evaluate the efficacy of ASD141 in specific solid tumor patients according to the RECIST v1.1 criteria for evaluating responses to solid tumors and the iRECIST criteria for evaluating responses to immune solid tumors.
Secondary Objectives:
⚫ Analyze the pharmacokinetic characteristics of ASD141
⚫ Analyze the immunogenicity of ASD141
⚫ Evaluate other antitumor effects of ASD141
Dose Increment and Dose Scalability Phases
Exploratory Objectives:
⚫ Evaluate ASD141 Correlation between antitumor activity and changes in cytokines/chemokines from baseline
⚫ Assess the correlation between the antitumor activity of ASD141 in subjects with advanced solid tumors and TREM-like transcript 1 (TLT-1) and CD11b expression levels
⚫ Assess the relationship between potential efficacy biomarkers and the antitumor activity of ASD141
⚫ Assess the differences between tumor tissue obtained during or after ASD141 treatment and biological specimens obtained at baseline
Test Drug
Injectable
Active Ingredient
ASD141
Dosage Form
270
Dosage
110 mg/5ml
Endpoints
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Inclution Criteria
Inclusion Criteria:
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
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).
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
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).
Exclusion Criteria
Exclusion Criteria:
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.
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.
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.
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.
The Estimated Number of Participants
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Taiwan
67 participants
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Global
67 participants
