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A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

Primary Purpose

Advanced Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Adebrelimab
SHR-1802
Carboplatin/Cisplatin
Paclitaxel/Nab-Paclitaxel/Pemetrexed
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Has a life expectancy≥ 12 weeks; At least one measurable lesion according to RECIST v1.1; Pathologically confirmed advanced solid tumor; Adequate bone marrow reserve and organ function. Exclusion Criteria: Have received anti-PD-1 or PD-L1 antibody therapy; Subjects with other malignant tumors in the past 3 years; Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; Previous or current interstitial pneumonia/interstitial lung disease ; History of autoimmune disease with the possibility of recurrence or active autoimmune disease; Severe infection within 1 month before the first study drug administration; The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.

Sites / Locations

  • Hunan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

phase Ib:SHR-1802+Adebrelimab

phase II cohort 1: SHR-1802+Adebrelimab

phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)

phase II cohort 3: SHR-1802+Adebrelimab + PDCT

phase II cohort 4: SHR-1802+Adebrelimab

Arm Description

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT)
Recommended phase II dose (RP2D)
ORR
Objective Response Rate, determined according to RECIST v1.1 criteria

Secondary Outcome Measures

DOR
Duration of Response, determined according to RECIST v1.1 criteria
DCR
Disease Control Rate, determined according to RECIST v1.1 criteria
PFS assessed by investigator
Progression Free Survival, determined according to RECIST v1.1 criteria
TTR
Time to Response,determined according to RECIST v1.1 criteria
OS (overall survival)
From date of treatment start to any cause death or last follow-up
12-month OS rate

Full Information

First Posted
March 20, 2023
Last Updated
May 31, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05794477
Brief Title
A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Official Title
An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Dose-exploration:Six patients will be enrolled for tolerability observation. If ≥2 subjects in the previous dose level experienced DLTS, an additional 6 subjects in the other dose level were enrolled. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
phase Ib:SHR-1802+Adebrelimab
Arm Type
Experimental
Arm Title
phase II cohort 1: SHR-1802+Adebrelimab
Arm Type
Experimental
Arm Title
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Arm Type
Experimental
Arm Title
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Arm Type
Experimental
Arm Title
phase II cohort 4: SHR-1802+Adebrelimab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Adebrelimab
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
SHR-1802
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin/Cisplatin
Intervention Description
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel/Nab-Paclitaxel/Pemetrexed
Intervention Description
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Time Frame
3 weeks
Title
Recommended phase II dose (RP2D)
Time Frame
up to 2 months
Title
ORR
Description
Objective Response Rate, determined according to RECIST v1.1 criteria
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
DOR
Description
Duration of Response, determined according to RECIST v1.1 criteria
Time Frame
up to 2 years
Title
DCR
Description
Disease Control Rate, determined according to RECIST v1.1 criteria
Time Frame
up to 2 years
Title
PFS assessed by investigator
Description
Progression Free Survival, determined according to RECIST v1.1 criteria
Time Frame
up to 2 years
Title
TTR
Description
Time to Response,determined according to RECIST v1.1 criteria
Time Frame
up to 2 years
Title
OS (overall survival)
Description
From date of treatment start to any cause death or last follow-up
Time Frame
up to 2 years
Title
12-month OS rate
Time Frame
from the date of the first dose up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Has a life expectancy≥ 12 weeks; At least one measurable lesion according to RECIST v1.1; Pathologically confirmed advanced solid tumor; Adequate bone marrow reserve and organ function. Exclusion Criteria: Have received anti-PD-1 or PD-L1 antibody therapy; Subjects with other malignant tumors in the past 3 years; Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; Previous or current interstitial pneumonia/interstitial lung disease ; History of autoimmune disease with the possibility of recurrence or active autoimmune disease; Severe infection within 1 month before the first study drug administration; The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuni Wang, M.M
Phone
+86 15921207253
Email
shuni.wang@hengrui.com
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wang, Doctor
Phone
+86-13973135460
Email
wanghui@hnca.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

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