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Clinical trial

A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.

ID
Name
SHR-1701-001AUS
Description
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.
Trial arms
Trial start
2020-03-31
Estimated PCD
2023-02-01
Trial end
2023-02-01
Status
Completed
Phase
Early phase I
Treatment
SHR-1701
Anti-PD-L1/TGFβ fusion protein
Arms:
Dose expansion 1, Dose expansion 2, Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5
Size
41
Primary endpoint
Adverse events
Screening up to study completion, an average of 1 year
Laboratory results
Screening up to study completion, an average of 1 year
Vital signs
Screening up to study completion, an average of 1 year
Electrocardiogram
Screening up to study completion, an average of 1 year
Eligibility criteria
Inclusion Criteria: * Diagnosed (histologically or cytologically) with solid tumors * ECOG Performance Status of 0 or 1 at both the screening and baseline visits * Life expectancy ≥12 weeks * Adequate laboratory parameters * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent Exclusion Criteria: * Known history of hypersensitivity to the study drug * Prior malignancy active within the previous 2 years * Any investigational or concurrent cancer therapy * History of immunodeficiency including seropositivity * Systemic antibiotics treatment for ≥ 7 days before the first dose * A known history of allogeneic organ transplantation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation is designed according to a modified 3+3 scheme, in which 3 to 6 subjects will be enrolled in each dose group. Four dose levels of SHR-1701 are planned. After completion of dose escalation, selected cohort(s) will be expanded.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}
Updated at
2023-02-21

1 organization

1 product

1 indication

Organization
Atridia
Product
SHR-1701
Indication
Advanced Solid Tumor