A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor

NCT07566247 | Not Yet Recruiting Phase 1

• 1 other identifier: AK150-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 (5)

• Serum PK concentration of AK150

  From pre-dose to the end of the last dose, an average of 6 months.

• The immunogenicity of AK150

  From pre-dose to 30 days post end of treatment

• Overall response rate (ORR)

  Up to 12 year.

• Progression-Free Survival(PFS)

  Up to 1 year

• Disease control rate(DCR)

  Up to 1 year.

Study Arms (1)

AK150

EXPERIMENTAL

Each subject will receive a single dose of AK150 every 2-week cycle (Q2W).

Drug: AK150

Interventions

AK150 DRUG

IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment

AK150

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• \. Participants with a history of mental illness and incapacitated or limited capacity.
• \. 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (3)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, 523000, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430040, China

Location

Central Study Contacts

Zhifang Yao, PHD

CONTACT

076089873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 21, 2029
• Study Completion (Estimated): June 7, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (3)