Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
NCT ID: NCT06686745
Last Updated: 2025-01-07
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
130 participants
INTERVENTIONAL
2024-12-06
2028-12-30
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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SIM0508 mono dose escalation
Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 Tablets
Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 combination dose escalation
Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.
SIM0508 in combination with olaparib
Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.
Interventions
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SIM0508 Tablets
Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
SIM0508 in combination with olaparib
Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.
Eligibility Criteria
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Inclusion Criteria
2. Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
3. ECOG score of 0 or 1.
4. Expected survival ≥ 12 weeks.
Exclusion Criteria
2. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
3. Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
4. Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
5. Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.
6. Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.
18 Years
ALL
No
Sponsors
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Shanghai Xianxiang Medical Technology Co., Ltd.
INDUSTRY
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Chongqing Cancer Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Hua Xiao Wu
Role: primary
Qi Zhou
Role: primary
Other Identifiers
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SIM0508-101
Identifier Type: -
Identifier Source: org_study_id
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