Advanced Malignant Solid TumorsPhase 1NCT07566247
A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
A Phase 1 study testing AK150 in people with Advanced Malignant Solid Tumors, run by Akeso at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- AK150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesChina
- Study dates
- 30 Apr 2026to 7 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Dongguan People's Hospital
Dongguan, Guangdong, 523000
Ruinian Zheng, M.D., 13450023449, 2857311978@qq.com
Ruinian Zheng, M.D.
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Zhangzhou Huang, M.D., 13609578088, 1609305255@qq.com
Zhang'zhou Huang, M.D.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430040
Tao Zhang, M.D., 13808640033, zhangtao@163.com
Xiaorong Dong, M.D., 13986252286, xhzzdxr@126.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor
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
- Being tested
- AK150
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK150Drug
IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment
| Study group | Role | What they receive |
|---|---|---|
| AK150 | Experimental | Each subject will receive a single dose of AK150 every 2-week cycle (Q2W). Receives: Drug: AK150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Serum PK of AK150 at different timepoints after AK150 administration
Measured: From pre-dose to the end of the last dose, an average of 6 months.
The immunogenicity of AK150
The immunogenicity of AK150 will be assessed by summarizing the number of participants who develop detectable anti-drug antibodies (ADAs)
Measured: From pre-dose to 30 days post end of treatment
Overall response rate (ORR)
Efficacy measures such as ORR, which is the proportion of participants with CR or PR by investigator based on RECIST v1.1
Measured: Up to 12 year.
Progression-Free Survival(PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
Measured: Up to 1 year
Disease control rate(DCR)
DCR, which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Measured: Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion21 Feb 2029 (estimated)
- Study completion7 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566247
- Sponsor's protocol ID
- AK150-101
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT07566247
- Acronym / sponsor ID
- AK150-101
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 21 Feb 2029 (estimated)
- Study completion
- 7 Jun 2029 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK150 | Experimental | Drug: AK150Each subject will receive a single dose of AK150 every 2-week cycle (Q2W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK150IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment | Drug | AK150 |
Primary outcome
Number of participants with a Dose Limiting Toxicity (DLT)
Time frame: During the first 4 weeks
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
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.
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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Related trials for Advanced Malignant Solid Tumors
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK150 in people with Advanced Malignant Solid Tumors, run by Akeso at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhifang Yao, PHD (076089873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a Dose Limiting Toxicity (DLT) (time frame: During the first 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.