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

NCT05794477 | Unknown Phase 1

• 1 other identifier: SHR-1802-II-202
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  3 weeks

• Recommended phase II dose (RP2D)

  up to 2 months

• ORR

  Objective Response Rate, determined according to RECIST v1.1 criteria

  up to 2 years

Secondary Outcomes (6)

• DOR

  up to 2 years

• DCR

  up to 2 years

• PFS assessed by investigator

  up to 2 years

• TTR

  up to 2 years

• OS (overall survival)

  up to 2 years

Study Arms (5)

phase Ib：SHR-1802+Adebrelimab

EXPERIMENTAL

Biological: Adebrelimab; Biological: SHR-1802

phase II cohort 1: SHR-1802+Adebrelimab

EXPERIMENTAL

Biological: Adebrelimab; Biological: SHR-1802

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

EXPERIMENTAL

Biological: Adebrelimab; Biological: SHR-1802; Drug: Carboplatin/Cisplatin; Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed

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

EXPERIMENTAL

Biological: Adebrelimab; Biological: SHR-1802; Drug: Carboplatin/Cisplatin; Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed

phase II cohort 4: SHR-1802+Adebrelimab

EXPERIMENTAL

Biological: Adebrelimab; Biological: SHR-1802

Interventions

Adebrelimab BIOLOGICAL

Specified dose on specified days

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; phase Ib：SHR-1802+Adebrelimab

SHR-1802 BIOLOGICAL

Specified dose on specified days

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; phase Ib：SHR-1802+Adebrelimab

Carboplatin/Cisplatin DRUG

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT); phase II cohort 3: SHR-1802+Adebrelimab + PDCT

Paclitaxel/Nab-Paclitaxel/Pemetrexed DRUG

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT); phase II cohort 3: SHR-1802+Adebrelimab + PDCT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

Carboplatin; Cisplatin; 130-nm albumin-bound paclitaxel; Pemetrexed

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Shuni Wang, M.M

CONTACT

+86 15921207253; shuni.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: April 28, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CN (1)