NCT06639347

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
13mo left

Started Nov 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2024May 2027

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

November 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

October 10, 2024

Last Update Submit

November 15, 2024

Conditions

Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (3)

  • Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer

    Up to approximately 5 years

  • Phase I: Incidence and severity of adverse events

    Up to approximately 5 years

  • Phase II: ORR by investigator assessment

    Up to approximately 5 years

Secondary Outcomes (14)

  • Phase I: ORR by investigator assessment

    Up to approximately 5 years

  • Phase I: DCR by investigator assessment

    Up to approximately 5 years

  • Phase I: DoR by investigator assessment

    Up to approximately 5 years

  • Phase I: PFS by investigator assessment

    Up to approximately 5 years

  • Phase I: OS by investigator assessment

    Up to approximately 5 years

  • +9 more secondary outcomes

Study Arms (1)

SHR-A2102 + Adebrelimab injection+SHR-8068 injection

EXPERIMENTAL
Drug: SHR-A2102Drug: Adebrelimab injectionDrug: SHR-8068 injection

Interventions

SHR-A2102DRUG

SHR-A2102

SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Adebrelimab injectionDRUG

Adebrelimab injection

SHR-A2102 + Adebrelimab injection+SHR-8068 injection
SHR-8068 injectionDRUG

SHR-8068 injection

SHR-A2102 + Adebrelimab injection+SHR-8068 injection

Eligibility Criteria

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

You may qualify if:

  • Competent to comprehend, sign, and date an informed consent form.
  • Male or female subjects must be age 18 or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subjects must have histologically documented, unresectable locally advanced or
  • Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
  • An archival tumor tissue sample or a fresh tissue sample should be provided.
  • Subjects must have measurable disease according to RECIST (version 1.1).

You may not qualify if:

  • Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
  • Subjects who have previously received TOPO1-based ADCs.
  • Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
  • Subjects who have received radiotherapy within 14 days , or chest radiotherapy \> 30Gy within 6 months prior to the first dose of study drug.
  • Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
  • Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
  • Subjects who have known or suspected interstitial pneumonitis.
  • Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
  • Subjects who have any active, known or suspected autoimmune diseases.
  • Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
  • Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Chun Yang

CONTACT

+86 15001953916chun.yang.cy35@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: SHR-A2102 with antitumor therapy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

November 4, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

November 18, 2024

Record last verified: 2024-10

Locations

CN(1)