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Not yet recruitingNCT07847281Updated Sep 29, 2026

A Study of AK157D1 for Injection in Advanced Solid Tumors

A Phase 1 interventional study of AK157D1 for injection in Advanced Solid Tumors, sponsored by Akeso. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Akeso · Phase 1, Interventional, and Treatment

Updated Sep 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
243
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be able to understand and voluntarily sign the written informed consent form.
  2. Aged of ≥ 18 years and ≤75 years.
  3. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
  4. At least one measurable lesion according to RECIST v1.1.
  5. ECOG PS 0 or 1.
  6. The expected lifespan is ≥3 months.
  7. Have sufficient organ function.
  8. Females participants must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.

Exclusion criteria

Exclusion Criteria:

  1. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
  2. Having other active malignancies within 3 years.
  3. Having received major surgical operations within 4 weeks before the first administration.
  4. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
  5. Participants with a history of mental illness and incapacitated or limited capacity.
  6. Having received systemic anti-tumor treatment within 3 weeks.
  7. Having received any treatment targeting B7H3.
  8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
  9. Previous history of severe hypersensitivity reactions.
  10. Participants with active autoimmune diseases requiring systemic treatment within 2 years.
  11. Known to be positive for HIV and other infections.
  12. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
  13. Live attenuated vaccines were received within 4 weeks.
  14. Currently participating in another interventional clinical study.
  15. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
243 participants (estimated)

Study arms

  • Experimental
    AK157D1 for injection

    AK157D1 for injection will be administered in prespecified dose levels

    Drug: AK157D1 for injection

Interventions

  • DrugAK157D1 for injection

    IV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the first 3 weeks of treatment.

  2. 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.

    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.

Secondary outcomes

  1. Area under curve (AUC)

    The area under the curve of the drug concentration in the blood over time

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

  2. Maximum Concentration (Cmax)

    The peak value of the plasma drug concentration reached on the time curve after a single administration

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

  3. Peak Time (Tmax)

    The time required for the drug concentration in human plasma to reach its peak (peak concentration) after administration

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

  4. 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%

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

  5. Clearance (CL)

    The ability of the kidneys to completely eliminate a certain substance from the plasma within a unit of time

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

  6. 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

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

  7. Anti-drug antibodies (ADA)

    The number and percentage of participants with detectable anti-drug antibodies (ADA)

    Time frame: From pre-dose to 30 days post end of treatment

  8. 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.

    Time frame: Up to approximately 2 years

  9. 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.

    Time frame: Up to approximately 2 years

  10. 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.

    Time frame: Up to approximately 2 years

  11. 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.

    Time frame: Up to approximately 2 years

  12. 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.

    Time frame: Up to approximately 2 years

  13. Overall survival (OS)

    OS is defined as the time from the first dose to death from any cause.

    Time frame: Up to approximately 2 years

07

Study locations

3 sites
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150081, China
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610044, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07847281
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Mar 30, 2029 (estimated)
Completion
Sep 15, 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Zhifang Yao, M.D.
Contact
clinicaltrails@akesobio.com
+86-0760-89873999

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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