A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients
NCT ID: NCT06911827
Last Updated: 2025-04-09
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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NOT_YET_RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2025-04-30
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ib/II
* Experimental: Ib： QLP2117 in combination with QL2107 Dose escalation and PK expansion
* Experimental: II： QLP2117 in combination with QL2107 Dose expansion
QLP2117
Specified dose on specified days
QL2107
Specified dose on specified days
Interventions
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QLP2117
Specified dose on specified days
QL2107
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Agree to provide archived tumor tissue samples of primary or metastatic lesions.
* Have adequate organ function as described in the protocol.
Exclusion Criteria
* HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
* Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy
* Has received a live vaccine wihtin 30 days of planned start of study treatment
* Known 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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Central Contacts
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Other Identifiers
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QLP2117-201
Identifier Type: -
Identifier Source: org_study_id
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