Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
NCT ID: NCT04871334
Last Updated: 2021-07-23
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
76 participants
INTERVENTIONAL
2021-02-07
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort
Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Dose Expansion Cohort
Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Interventions
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TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG score 0 or 1;
* Part B: At least 1 measurable lesion according to RECIST 1.1
Exclusion Criteria
* Receiving any anti-cancer drugs;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* 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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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TWP-101-11
Identifier Type: -
Identifier Source: org_study_id
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