Recruiting NCT06929663
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK146D1 for injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors
Overview
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
Interventions
- Drug AK146D1 for injection
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate
Primary outcome measures
- Number of participants with dose limiting toxicities (DLTs) [Time frame: During the first 3 weeks of treatment.]
- Number of participants with adverse events (AEs) [Time frame: From the time of informed consent signed through 90 days after the last dose of study drug]
Secondary outcome measures (8)
- Serum PK concentration of AK146D1 [Time frame: From pre-dose to the end of the last dose, an average of 6 months.]
- Anti-drug antibodies (ADA) [Time frame: From pre-dose to 90 days post end of treatment]
- Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) assessed per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Time to response (TTR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Overall survival (OS) [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Be able to understand and voluntarily sign the written informed consent form.
- Aged of ≥ 18 years and ≤75 years.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- At least one measurable lesion according to RECIST v1.1.
- Have sufficient organ function.
- Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
Exclusion criteria
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having received any treatment targeting Trop2 or Nectin4 or any treatment with topoisomerase I inhibitor agents.
- Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
- Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
- Known to be positive for HIV and other infections.
- Previous history of severe hypersensitivity reactions.
- Live attenuated vaccines were received within 4 weeks.
- Subjects with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Scientia Clinical Research — Sydney
Identifiers
NCT: NCT06929663 · AK146D1-102