Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
NCT ID: NCT05024305
Last Updated: 2022-03-09
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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UNKNOWN
PHASE1
81 participants
INTERVENTIONAL
2022-03-08
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort
Four dose levels of TWP-102 injection will be tested by BOIN study design.
TWP-102 injection
IV infusion
Dose Expansion Cohort
Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.
TWP-102 injection
IV infusion
Interventions
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TWP-102 injection
IV infusion
Eligibility Criteria
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Inclusion Criteria
* At least 1 measurable lesion.
* ECOG score 0 or 1;
* Life expectancy of ≥ 3 months;
Exclusion Criteria
* Receiving any anti-cancer drugs within 4 weeks;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \> 1 severity that is related to prior anti-cancer therapy. (except alopecia)
* Pregnancy or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Shandong TheraWisdom Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Qingyuan Zhang
Role: primary
Other Identifiers
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TWP-102-11
Identifier Type: -
Identifier Source: org_study_id
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