An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05794477

Collaborator

(none)

132

Enrollment

Arms

32.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Biological: Adebrelimab Biological: SHR-1802 Drug: Carboplatin/Cisplatin Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

Anticipated Study Start Date :

Apr 28, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: phase Ib：SHR-1802+Adebrelimab	Biological: Adebrelimab Specified dose on specified days Biological: SHR-1802 Specified dose on specified days
Experimental: phase II cohort 1: SHR-1802+Adebrelimab	Biological: Adebrelimab Specified dose on specified days Biological: SHR-1802 Specified dose on specified days
Experimental: phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)	Biological: Adebrelimab Specified dose on specified days Biological: SHR-1802 Specified dose on specified days Drug: Carboplatin/Cisplatin Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Experimental: phase II cohort 3: SHR-1802+Adebrelimab + PDCT	Biological: Adebrelimab Specified dose on specified days Biological: SHR-1802 Specified dose on specified days Drug: Carboplatin/Cisplatin Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Experimental: phase II cohort 4: SHR-1802+Adebrelimab	Biological: Adebrelimab Specified dose on specified days Biological: SHR-1802 Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Dose limiting toxicity (DLT) [3 weeks]
Recommended phase II dose (RP2D) [up to 2 months]
ORR [up to 2 years]
Objective Response Rate, determined according to RECIST v1.1 criteria

Secondary Outcome Measures

DOR [up to 2 years]
Duration of Response, determined according to RECIST v1.1 criteria
DCR [up to 2 years]
Disease Control Rate, determined according to RECIST v1.1 criteria
PFS assessed by investigator [up to 2 years]
Progression Free Survival, determined according to RECIST v1.1 criteria
TTR [up to 2 years]
Time to Response，determined according to RECIST v1.1 criteria
OS (overall survival) [up to 2 years]
From date of treatment start to any cause death or last follow-up
12-month OS rate [from the date of the first dose up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Hengrui Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05794477

Other Study ID Numbers:

SHR-1802-II-202

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023