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

Metastatic Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235437
• Other study ID #: ABU001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Ascendo Biotechnology Co., Ltd.
• Contact: Ruby Lin, M.S.
• Phone: +886277288922
• Email: ruby.lin[@]ascendobiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 4 dose cohorts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: December 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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:

• 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 who are not currently on 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.

• 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.

Related Conditions & MeSH terms

• Metastatic Solid Tumor

Intervention

Biological:
• ASD141
Subjects will receive one of 4 dose levels of ASD141.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ascendo Biotechnology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose-limiting toxicity	Frequency of dose-limiting toxicity (DLT) at each dose level	28 days
Primary	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	Plasma Cmax	maximum measured concentration of ASD141 in plasma	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	Plasma AUClast	area under the plasma concentration-time curve of ASD141 from hour 0 to last sample with measurable plasma concentrations	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	Plasma AUCinfinity	area under the plasma concentration-time curve of ASD141 in plasma over the time interval from 0 extrapolated to infinity	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	Plasma t1/2	terminal half-life of ASD141 in plasma	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	Plasma tmax	Time of the maximum observed ASD141 concentration	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	anti-drug antibodies (ADAs)	Presence or absence of anti-drug antibodies (ADAs) against ASD141	Dose Escalation (From the time of informed consent until 90 days after the last dose of ASD141)
Secondary	Objective response rate	Percentage of participants with a confirmed CR or PR according to RECIST v1.1	Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Secondary	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	Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Secondary	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	Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)
Secondary	Duration of response	The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression	Dose Escalation (From first dose of ASD141 to progressive disease (PD) or death in the absence of disease progression (approximately 1 year)