Advanced Solid TumorsPhase 1NCT07847281
A Study of AK157D1 for Injection in Advanced Solid Tumors
A Phase 1 study testing AK157D1 for injection in people with Advanced Solid Tumors, run by Akeso at 3 sites in China.
Trial summary
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AK157D1 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 3 sitesChina
- Study dates
- 30 Sep 2026to 15 Sep 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
- No healthy volunteers
- 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.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- At least one measurable lesion according to RECIST v1.1.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Have sufficient organ function.
- Females participants must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.
Who cannot join
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having other active malignancies within 3 years.
- Having received major surgical operations within 4 weeks before the first administration.
- Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Participants with a history of mental illness and incapacitated or limited capacity.
- Having received systemic anti-tumor treatment within 3 weeks.
Show all 15Show fewer
- Having received any treatment targeting B7H3.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- Previous history of severe hypersensitivity reactions.
- Participants with active autoimmune diseases requiring systemic treatment within 2 years.
- Known to be positive for HIV and other infections.
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
- Live attenuated vaccines were received within 4 weeks.
- Currently participating in another interventional clinical study.
- 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, 3 recruiting
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Jianxin Xue, M.D., +86-18982251798, killercell@163.com
Li Zheng, M.D., +86-18980601950, lzheng2005618@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, M.D., +86-15134569619, ztsgcp@126.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren, M.D., +86-13816756732, harry_ren@126.com
About this study
Official title: A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK157D1 in the Treatment of Advanced Solid Tumors Conditions
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- AK157D1 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK157D1 for injectionDrug
IV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment
| Study group | Role | What they receive |
|---|---|---|
| AK157D1 for injection | Experimental | AK157D1 for injection will be administered in prespecified dose levels Receives: Drug: AK157D1 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Measured: During the first 3 weeks of treatment.
Number of participants with adverse events (AEs)
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
Measured: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
Secondary outcomes (13)
Area under curve (AUC)
The area under the curve of the drug concentration in the blood over time
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Maximum Concentration (Cmax)
The peak value of the plasma drug concentration reached on the time curve after a single administration
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Peak Time (Tmax)
The time required for the drug concentration in human plasma to reach its peak (peak concentration) after administration
Measured: From pre-dose to the end of the last dose, an average of 6 months.
The terminal elimination half-life (t1/2)
The time that takes for the elimination processes to reduce the plasma concentration of the drug in the body by 50%
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Clearance (CL)
The ability of the kidneys to completely eliminate a certain substance from the plasma within a unit of time
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Volume of distribution (V)
The total volume of body fluid required for a drug, calculated based on the blood drug concentration in a dynamic equilibrium state
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Anti-drug antibodies (ADA)
The number and percentage of participants with detectable anti-drug antibodies (ADA)
Measured: From pre-dose to 30 days post end of treatment
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.
Measured: Up to approximately 2 years
Disease Control Rate (DCR) assessed per RECIST v1.1
DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
TTR is defined as the time to objective response based on RECIST v1.1.
Measured: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from the first dose to death from any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847281
- Sponsor's protocol ID
- AK157D1-101
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK157D1 in the Treatment of Advanced Solid Tumors Conditions
- ClinicalTrials.gov ID
- NCT07847281
- Acronym / sponsor ID
- AK157D1-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 29 Sep 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 is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK157D1 for injection | Experimental | Drug: AK157D1 for injectionAK157D1 for injection will be administered in prespecified dose levels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not 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.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- At least one measurable lesion according to RECIST v1.1.
- ECOG PS 0 or 1.
Key exclusion criteria (15 listed)
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having other active malignancies within 3 years.
- Having received major surgical operations within 4 weeks before the first administration.
- Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Participants with a history of mental illness and incapacitated or limited capacity.
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 |
|---|---|---|
| AK157D1 for injectionIV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment | Drug | AK157D1 for injection |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: During the first 3 weeks of treatment.
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Number of participants with adverse events (AEs)
Time frame: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
13 secondary outcomes
Area under curve (AUC)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Maximum Concentration (Cmax)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Peak Time (Tmax)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
The terminal elimination half-life (t1/2)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Clearance (CL)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Volume of distribution (V)
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Anti-drug antibodies (ADA)
Time frame: From pre-dose to 30 days post end of treatment
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) assessed per RECIST v1.1
Time frame: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
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 13 Oct 2026.
Related trials for Advanced Solid Tumors
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
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 AK157D1 for injection in people with Advanced 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 15 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: looking for participants now, as of the sponsor's last update on 13 Oct 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, M.D. (+86-0760-89873999, clinicaltrails@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 dose limiting toxicities (DLTs) (time frame: During the first 3 weeks of treatment.). 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 13 Oct 2026.