A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
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: AK150.
- Who it may be relevant to
- Registry conditions: Advanced Malignant 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
- China
- 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 I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor
Overview
This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.
Interventions
- Drug AK150
IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment
Primary outcome measures
- Number of participants with a Dose Limiting Toxicity (DLT) [Time frame: During the first 4 weeks]
- Number of participants with adverse events (AEs) [Time frame: From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.]
Secondary outcome measures (5)
- Serum PK concentration of AK150 [Time frame: From pre-dose to the end of the last dose, an average of 6 months.]
- The immunogenicity of AK150 [Time frame: From pre-dose to 30 days post end of treatment]
- Overall response rate (ORR) [Time frame: Up to 12 year.]
- Progression-Free Survival(PFS) [Time frame: Up to 1 year]
- Disease control rate(DCR) [Time frame: Up to 1 year.]
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 or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
- At least one measurable lesion according to RECIST v1.1.
- Adequate 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 participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having received any treatment targeting CSF-1R, ILT2 and ILT4..
- Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Participants with active autoimmune diseases requiring systemic treatment within 2 years.
- Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.
- Known to be positive for HIV and other infections.
- Live attenuated vaccines were received within 28 days.
13\. Participants with a history of mental illness and incapacitated or limited capacity.
14\. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant 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: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Fujian Cancer Hospital — Fuzhou
- Dongguan People's Hospital — Dongguan
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07566247 · AK150-101