A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors

NCT03871855 | Terminated Phase 1

• 1 other identifier: SHR-1702-I-101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants with DLTs

  Approximately 28 Days

Secondary Outcomes (10)

• ORR: Percentage of Participants With a CR or PR

  Approximately 2 years

• Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.

  Dose Escalation Part -- Approximately 2 years

• Immunogenicity as assessed by the presence of anti-drug antibodies

  Approximately 2 years

• Pharmacodynamic profile as assessed by receptor occupancy

  Approximately 2 years

• PK Parameter: Maximum Concentration (Cmax)

  Approximately 2 years

Study Arms (4)

A:SHR-1702 Dose Escalation

EXPERIMENTAL

SHR-1702 given intravenously (IV).

Drug: SHR-1702

B:SHR-1702 Dose Expansion

EXPERIMENTAL

SHR-1702 given intravenously (IV).

Drug: SHR-1702

C:SHR-1702 and Camrelizumab Dose Escalation

EXPERIMENTAL

SHR-1702 and Camrelizumab given intravenously (IV).

Drug: SHR-1702; Drug: Camrelizumab

D:SHR-1702 and Camrelizumab Dose Expansion

EXPERIMENTAL

SHR-1702 and Camrelizumab given intravenously (IV).

Drug: SHR-1702; Drug: Camrelizumab

Interventions

SHR-1702 DRUG

Administered IV

A:SHR-1702 Dose Escalation; B:SHR-1702 Dose Expansion; C:SHR-1702 and Camrelizumab Dose Escalation; D:SHR-1702 and Camrelizumab Dose Expansion

Camrelizumab DRUG

Administered IV

C:SHR-1702 and Camrelizumab Dose Escalation; D:SHR-1702 and Camrelizumab Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed advanced relapsed/refractory solid tumors
• Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Have an estimated life expectancy of 12 weeks, in judgement of the investigator；
• Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
• Adequate hematologic and organ function
• Signed inform consent form

You may not qualify if:

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Significant cardiovascular disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
• History of autoimmune disease.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
• Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C
• Active or untreated central nervous system (CNS) metastases
• Active infection within 2 weeks
• History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins
• Prior allogeneic bone marrow transplantation or solid organ transplant
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

camrelizumab

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

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: March 12, 2019
• Study Start: April 28, 2019
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

CN (1)