A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors
NCT ID: NCT05162469
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2022-02-23
2024-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-1909 monotherapy
SHR-1909 injection
SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).
Interventions
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SHR-1909 injection
SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).
Eligibility Criteria
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Inclusion Criteria
* Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
* Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
* Adequate organ function.
Exclusion Criteria
* Received prior CAR T-cell therapy;
* Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
* With active infection or fever of unknown origin (\> 38.5 °C).
18 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Jilin Cancer Hospital
Changchun, Jilin, China
Countries
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Other Identifiers
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SHR-1909-I-101
Identifier Type: -
Identifier Source: org_study_id
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