A Phase I Clinical Study of AK150 in Advanced Malignant S... | NCT07566247

NCT07566247

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
AK150	Experimental	Each subject will receive a single dose of AK150 every 2-week cycle (Q2W).	Drug: AK150

Name	Type	Description	Arm Group Labels	Other Names
AK150	Drug	IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment	AK150

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with a Dose Limiting Toxicity (DLT)	DLTs will be assessed during the first 4 weeks of treatment for dose-escalation I phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (4 weeks) of treatment	During the first 4 weeks
Number of participants with adverse events (AEs)	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment	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 Outcomes

Measure	Description	Time Frame
Serum PK concentration of AK150	Serum PK of AK150 at different timepoints after AK150 administration	From pre-dose to the end of the last dose, an average of 6 months.
The immunogenicity of AK150

Eligibility Module

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.