Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141

NCT06235437 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ABU001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.

Conditions

Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicity

  Frequency of dose-limiting toxicity (DLT) at each dose level

  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)

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

Secondary Outcomes (10)

• Plasma Cmax

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

• Plasma AUClast

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

• Plasma AUCinfinity

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

• Plasma t1/2

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

• Plasma tmax

  Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)

Study Arms (1)

ASD141

EXPERIMENTAL

IV, Monotherapy

Biological: ASD141

Interventions

ASD141 BIOLOGICAL

Subjects will receive one of 8 dose levels of ASD141.

ASD141

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascendo Biotechnology Co., Ltd.: lead

Study Sites (2)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Min Yeh, M.D. PhD.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-FANG TSAI, M.S.

CONTACT

+886277288922; ifang.tsai@ascendobiotech.com

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 1, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)