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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794477
• Other study ID #: SHR-1802-II-202
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Shuni Wang, M.M
• Phone: +86 15921207253
• Email: shuni.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• Adebrelimab
Specified dose on specified days
• 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.
• 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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)		3 weeks
Primary	Recommended phase II dose (RP2D)		up to 2 months
Primary	ORR	Objective Response Rate, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	DOR	Duration of Response, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	DCR	Disease Control Rate, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	PFS assessed by investigator	Progression Free Survival, determined according to RECIST v1.1 criteria	up to 2 years
Secondary	TTR	Time to Response,determined according to RECIST v1.1 criteria	up to 2 years
Secondary	OS (overall survival)	From date of treatment start to any cause death or last follow-up	up to 2 years
Secondary	12-month OS rate		from the date of the first dose up to 2 years