CompletedNCT04414150Updated Oct 26, 2022

A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours

A Phase 1 interventional study of SHR-1802 in Malignant Tumours, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.

Conditions studied

Malignant Tumours

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Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Voluntary participation and written informed consent;
Aged 18-75 years (inclusive), males and females;
Patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
At least one measurable lesion according to RECIST v1.1;
ECOG score of 0-1;
Expected survival ≥ 12 weeks;
Adequate bone marrow reserve and organ function were confirmed by baseline examination
For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;

Exclusion criteria

Exclusion Criteria:

The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period;
Subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration.
Known and untreated central nervous system (CNS) or leptomeningeal metastases;
Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures;
Uncontrolled cardiac diseases or symptoms;
Known hereditary or acquired bleeding and thrombotic tendencies;
Patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with \< 5 drug half-lives from the first study dose; or patients with AEs caused by previous treatment (except for alopecia) that have not returned to CTCAE Grade ≤ 1;
Known active infection,;
Congenital and acquired immune deficiency;
HBsAg-positive and HBV DNA > 2000 IU/mL(or 104 copies/mL); HCV RNA copies > ULN;
Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Experimental
SHR-1802
Drug: SHR-1802

Interventions

DrugSHR-1802
This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.

What researchers measure

Primary outcomes

Dose limiting toxicity
Time frame: Days 1-21

Secondary outcomes

Percentage of patients with adverse events
Time frame: from the first drug administration to within 90 days for the last SHR-1802 dose
Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events
Time frame: At pre-defined intervals from initial dose up to 24 months
ORR
Time frame: At pre-defined intervals from initial dose up to 24 months
DOR
Time frame: At pre-defined intervals from initial dose up to 24 months
DCR
Time frame: At pre-defined intervals from initial dose up to 24 months
PFS
Time frame: At pre-defined intervals from initial dose up to 24 months
Maximum Concentration (Cmax) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Time of Maximum Concentration (Tmax) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Area Under the Curve (AUC) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Terminal Half-Life (T1/2) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Clearance (CL) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Volume of Distribution at Steady State (Vss) of SHR-1802
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Evaluation of the immunogenicity of SHR-1802
Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)

Study locations

1 site

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04414150
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Jun 4, 2020
Start date: Jun 17, 2020
Primary completion: Jan 13, 2022
Completion: Mar 15, 2022
Last update: Oct 26, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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