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

May 31, 2023 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent；
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  3. Has a life expectancy≥ 12 weeks；
  4. At least one measurable lesion according to RECIST v1.1；
  5. Pathologically confirmed advanced solid tumor；
  6. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

  1. Have received anti-PD-1 or PD-L1 antibody therapy;
  2. Subjects with other malignant tumors in the past 3 years;
  3. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
  4. Previous or current interstitial pneumonia/interstitial lung disease ;
  5. History of autoimmune disease with the possibility of recurrence or active autoimmune disease;
  6. Severe infection within 1 month before the first study drug administration;
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 2 years
Objective Response Rate, determined according to RECIST v1.1 criteria
up to 2 years
Dose limiting toxicity (DLT)
Time Frame: 3 weeks
3 weeks
Recommended phase II dose (RP2D)
Time Frame: up to 2 months
up to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1802-II-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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