A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
NCT ID: NCT05830045
Last Updated: 2024-06-27
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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RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2023-05-19
2025-12-31
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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Ia： QLP2117 Dose escalation and PK expansion
QLP2117
Specified dose on specified days
Ib：QLP2117 Dose expansion
QLP2117
Specified dose on specified days
Interventions
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QLP2117
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion)
3. Eastern Cooperative Oncology Group Performance Status of 0 or 1
4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.
5. Have adequate organ function as described in the protocol.
Exclusion Criteria
2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
4. Has an active autoimmune disease that has required systemic treatment in past 2 years.
5. Has an active infection requiring systemic therapy
6. Has received a live vaccine wihtin 30 days of planned start of study treatment
7. Has know history of, or any evidence of interstitial lung disease
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xu Ruihua, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Xu Ruihua
Role: primary
Role: backup
Other Identifiers
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QLP2117-101
Identifier Type: -
Identifier Source: org_study_id
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