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NCT Number: NCT07636772

A Phase II Study of AK146D1 Mono or Combined With AK112 in 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.

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Key information

Conditions

Urothelial Carcinoma (UC) Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

AK146D1 for injection

Drug

AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate

AK112 Injection

Drug

AK112 Injection is a PD-1/VEGF bispecific antibody

Primary outcomes

  1. 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

  2. Objective Response Rate(ORR)

    Time frame: Up to 2 years

    ORR is the proportion of participants with complete response(CR) or partial response(PR)

  3. 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.

Secondary outcomes

  1. Progression Free Survival(PFS)

    Time frame: Up to 2 years

    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.

  2. Disease Control Rate(DCR)

    Time frame: Up to 2 years

    DCR is defined as the proportion of participants with CR, PR, or SD

  3. Duration of response(DoR)

    Time frame: Up to 2 years

    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.

  4. Time to response(TTR)

    Time frame: Up to 2 years

    TTR is defined as the time to objective response

  5. Overall survival(OS)

    Time frame: Up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Liu

CONTACT

[email protected]

+86 (0760) 8987 3999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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