Urothelial Carcinoma (UC)Phase 2NCT07636772
A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
A Phase 2 study testing AK146D1 for injection and AK112 Injection in people with Urothelial Carcinoma (UC), run by Akeso at 1 site in China.
Trial summary
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urothelial Carcinoma (UC)
- What is being tested?
- AK146D1 for injection and AK112 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 24 Aug 2028
- Phase
- Phase 2
- 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.
- Age 18-75.
- ECOG PS 0 or 1.
- Expected lifespan ≥3 months.
- Histologically or cytologically documented Urothelial carcinoma.
- At least one measurable lesion according to RECIST v1.1.
- Sufficient organ function.
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.
- Prior chemotherapy agent targeting topoisomerase I .
- Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.
- Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
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- Patients with active autoimmune diseases requiring systemic treatment within 2 years.
- Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- Previous history of severe hypersensitivity reactions.
- Patients with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise patient 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.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Dingwei Ye, 021-64175590, dwyeli@163.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
- Conditions
- Urothelial Carcinoma (UC)
- Being tested
- AK146D1 for injection, AK112 Injection
- Medical subject headings
- Carcinoma, Transitional Cell
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 antiTrop2/Nectin4 bispecific antibody-drug conjugate
AK112 InjectionDrug
AK112 Injection is a PD-1/VEGF bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AK146D1 combined with AK112 Receives: Drug: AK146D1 for injection; Drug: AK112 Injection |
| Arm B | Experimental | AK146D1 mono 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 predefined severity criteria, and assessed as having a suspected relationship to study drug
Measured: During the first 3 weeks of treatment
Objective Response Rate(ORR)
ORR is the proportion of participants with complete response(CR) or partial response(PR)
Measured: Up to 2 years
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 informed consent signed through 90 days after the last dose
Secondary outcomes (5)
Progression Free Survival(PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause,whichever occurs first.
Measured: Up to 2 years
Disease Control Rate(DCR)
DCR is defined as the proportion of participants with CR, PR, or SD
Measured: Up to 2 years
Duration of response(DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Time to response(TTR)
TTR is defined as the time to objective response
Measured: Up to 2 years
Overall survival(OS)
OS is defined as the time from the first dose to death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion24 Aug 2028 (estimated)
- Study completion24 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636772
- Sponsor's protocol ID
- AK146D1-203
- Status last verified
- May 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07636772
- Acronym / sponsor ID
- AK146D1-203
- Conditions
- Urothelial Carcinoma (UC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 24 Aug 2028 (estimated)
- Study completion
- 24 Aug 2028 (estimated)
- First posted
- 9 Jun 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 a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AK146D1 for injection, Drug: AK112 InjectionAK146D1 combined with AK112 |
| Arm B | Experimental | Drug: AK146D1 for injectionAK146D1 mono |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to understand and voluntarily sign the written informed consent form.
- Age 18-75.
- ECOG PS 0 or 1.
- Expected lifespan ≥3 months.
- Histologically or cytologically documented Urothelial carcinoma.
Key exclusion criteria (11 listed)
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system.
- Prior chemotherapy agent targeting topoisomerase I .
- Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.
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 antiTrop2/Nectin4 bispecific antibody-drug conjugate | Drug | Arm A, Arm B |
| AK112 InjectionAK112 Injection is a PD-1/VEGF bispecific antibody | Drug | Arm A |
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 predefined severity criteria, and assessed as having a suspected relationship to study drug
Objective Response Rate(ORR)
Time frame: Up to 2 years
ORR is the proportion of participants with complete response(CR) or partial response(PR)
Number of participants with adverse events (AEs)
Time frame: From the time of informed consent signed through 90 days after the last dose
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.
5 secondary outcomes
Progression Free Survival(PFS)
Time frame: Up to 2 years
Disease Control Rate(DCR)
Time frame: Up to 2 years
Duration of response(DoR)
Time frame: Up to 2 years
Time to response(TTR)
Time frame: Up to 2 years
Overall survival(OS)
Time frame: Up to 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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK146D1 for injection and AK112 Injection in people with Urothelial Carcinoma (UC), 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 7 inclusion and 11 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 9 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 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 9 Jun 2026.