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ClinicalTrials.gov ID

NCT07566247

Lead Sponsor

AkesoINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

96Estimated

Last Update Posted

May 5, 2026Actual

Start Date

Apr 30, 2026Estimated

Primary Completion Date

Feb 21, 2029Estimated

Completion Date

Jun 7, 2029Estimated

Official Title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor

Brief Summary

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.

• Advanced Malignant Solid Tumors

• AK150

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Be able to understand and voluntarily sign the written informed consent form.
2. Aged of ≥ 18 years and ≤75 years.
3. ECOG PS 0 or 1.
4. The expected lifespan is ≥3 months.
5. 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.
6. At least one measurable lesion according to RECIST v1.1.
7. Adequate organ function.
8. 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:

1. Having other active malignancies within 3 years.
2. Currently participating in another interventional clinical study.
3. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
4. Having received any treatment targeting CSF-1R, ILT2 and ILT4..
5. Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.
6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
7. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
8. Participants with active autoimmune diseases requiring systemic treatment within 2 years.
9. 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.
10. Known to be positive for HIV and other infections.
11. 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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

AkesoINDUSTRY

2857311978@qq.com13450023449