Advanced Solid TumorsPhase 1NCT07067567
A Study of AK146D1 for Injection in Advanced Solid Tumors
A Phase 1 study testing AK146D1 for injection in people with Advanced Solid Tumors, run by Akeso at 1 site 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 AK146D1 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?
- AK146D1 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to 5 May 2027
- 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.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- 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.
- Have sufficient 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 patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having received any treatment targeting Trop2 or Nectin4.
- Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
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- Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
- Known to be positive for HIV and other infections.
- Previous history of severe hypersensitivity reactions.
- Live attenuated vaccines were received within 4 weeks.
- Subjects with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li Zhang, Study Principal Investigator contact
China1 site, 1 recruiting
- Recruiting
SunYat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang, Study Principal Investigator, zhangli@sysucc.org.cn
About this study
Official title: A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- AK146D1 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK146D1 for injectionDrug
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| AK146D1 for injection | Experimental | AK146D1 for injection will be administered in prespecified dose levels Receives: Drug: AK146D1 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 (8)
Serum PK concentration of AK146D1
Serum PK concentration of AK146D1 in participants after administration
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 posted16 Jul 2025
- Study start7 Aug 2025
- Primary completion5 Nov 2026 (estimated)
- Study completion5 May 2027 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067567
- Sponsor's protocol ID
- AK146D1-101
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07067567
- Acronym / sponsor ID
- AK146D1-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 16 Jul 2025 (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 AK146D1 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 |
|---|---|---|
| AK146D1 for injection | Experimental | Drug: AK146D1 for injectionAK146D1 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.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
Key exclusion criteria (14 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 patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having received any treatment targeting Trop2 or Nectin4.
- Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
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 |
|---|---|---|
| AK146D1 for injectionAK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate | Drug | AK146D1 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.
8 secondary outcomes
Serum PK concentration of AK146D1
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 3 Sep 2025.
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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.
Li Zhang, Study Principal Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK146D1 for injection in people with Advanced Solid Tumors, run by Akeso at 1 site 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 14 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ting Liu (+86(0760)8987 3999, 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 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 3 Sep 2025.