NCT07636772

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
26mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 22, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2028

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Urothelial Carcinoma (UC)

Outcome Measures

Primary Outcomes (3)

  • 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

    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)

    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.

    From the time of informed consent signed through 90 days after the last dose

Secondary Outcomes (5)

  • Progression Free Survival(PFS)

    Up to 2 years

  • Disease Control Rate(DCR)

    Up to 2 years

  • Duration of response(DoR)

    Up to 2 years

  • Time to response(TTR)

    Up to 2 years

  • Overall survival(OS)

    Up to 2 years

Study Arms (2)

Arm A

EXPERIMENTAL

AK146D1 combined with AK112

Drug: AK146D1 for injectionDrug: AK112 Injection

Arm B

EXPERIMENTAL

AK146D1 mono

Drug: AK146D1 for injection

Interventions

AK146D1 for injectionDRUG

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

Arm AArm B
AK112 InjectionDRUG

AK112 Injection is a PD-1/VEGF bispecific antibody

Arm A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Injections

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Ting Liu

CONTACT

+86 (0760) 8987 3999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

August 24, 2028

Study Completion (Estimated)

August 24, 2028

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)