A Study of QLF3108 in Participants With Advanced Solid Tumor
NCT ID: NCT06019013
Last Updated: 2023-08-31
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
78 participants
INTERVENTIONAL
2023-08-16
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose-Escalation Stage and PK-Expansion Stage
Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD).
PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial.
QLF3108
QLF3108 will be administered independent of body weight.
Interventions
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QLF3108
QLF3108 will be administered independent of body weight.
Eligibility Criteria
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Inclusion Criteria
2. ≥18 years old and body weight ≥40 kg; Female or male.
3. Histologically or cytologically documented advanced solid tumor;
4. Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
5. Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
6. Life expectancy of at least 12 weeks.
7. Adequate hematologic and end organ function.
8. Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing.
9. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
Exclusion Criteria
2. Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
3. Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
4. A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
5. Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
6. Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period.
7. Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation).
8. Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study.
9. Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.
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 Jianming, M.D
Role: PRINCIPAL_INVESTIGATOR
Chinese People's Liberation Army (PLA) General Hospital
Locations
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Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xu Jianming, M.D
Role: primary
Other Identifiers
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QLF3108-101
Identifier Type: -
Identifier Source: org_study_id