A Trial of SHR-A2102 With Antitumor Therapy in Advanced U... | NCT06639347

Studies
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

NCT06639347

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Nov 18, 2024Actual

Enrollment

90Estimated

Phase

Phase 1Phase 2

Conditions

Advanced Urothelial Carcinoma

Interventions

SHR-A2102
Adebrelimab injection
SHR-8068 injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2024Actual

Primary Completion Date

May 31, 2027Estimated

Completion Date

May 31, 2027Estimated

First Submitted Date

Oct 10, 2024

First Submission Date that Met QC Criteria

Oct 10, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2024

Last Update Posted Date

Nov 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Label	Type	Description	Intervention Names
SHR-A2102 + Adebrelimab injection+SHR-8068 injection	Experimental		Drug: SHR-A2102 Drug: Adebrelimab injection Drug: SHR-8068 injection

Name	Type	Description	Arm Group Labels	Other Names
SHR-A2102	Drug	SHR-A2102	SHR-A2102 + Adebrelimab injection+SHR-8068 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided