A Study of RC88 Combined With Sintilimab for Advanced Sol... | NCT05804526

Studies
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

NCT05804526

Sponsor

RemeGen Co., Ltd.

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

82Estimated

Phase

Phase 1Phase 2

Conditions

Advanced Solid Tumours

Interventions

RC88
Sintilimab 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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2023Actual

Primary Completion Date

May 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 26, 2023

First Submission Date that Met QC Criteria

Mar 26, 2023

First Posted Date

Apr 7, 2023Actual

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

Apr 29, 2024

Last Update Posted Date

Apr 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RC88+Sintilimab Injection	Experimental	RC88+Sintilimab Injection Arm	Drug: RC88 Drug: Sintilimab Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RC88	Drug	1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks	RC88+Sintilimab Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RP2D	Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab	28 days after first treatment

Secondary Outcomes

Measure	Description	Time Frame
ORR	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)	24 months
Maximum Concentration (Cmax) of RC88	Dose Escalation and Expansion Part

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary agreement to provide written informed consen
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Predicted survival ≥ 12 weeks
Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
Adequate organ function required
Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

Cancer metastases in the brain
Active infection or past hepatitis B or C infection
Major surgery less than 1 month before the start of the study
Uncontrolled heart disease
History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heping Liu	Contact	+8610-58075763		heping.liu@remegen.com

Overall Officials

Name	Affiliation	Role
Shi Yuankai, M.D.	Leading PI	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Recruiting	Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided