A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
NCT ID: NCT07198633
Last Updated: 2025-09-30
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
212 participants
INTERVENTIONAL
2025-10-31
2027-12-31
Brief Summary
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The study consists of two stages:
Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.
Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QLC5508+NHA
QLC5508
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
abiraterone acetate
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
enzalutamide
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
QLC5508+QLH12016
QLC5508
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
QLH12016
An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol
QLC5508+QLH12016+NHA
QLC5508
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
abiraterone acetate
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
enzalutamide
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
QLH12016
An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol
QLH12016+NHA
QLC5508
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
abiraterone acetate
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
enzalutamide
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
Interventions
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QLC5508
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
abiraterone acetate
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
enzalutamide
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
QLH12016
An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol
Eligibility Criteria
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Inclusion Criteria
* Male, aged ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
* Life expectancy of at least 3 months.
* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Radiologically confirmed metastatic prostate cancer.
* For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.
* Must have undergone surgical castration or be willing to receive medical castration.
* For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.
* Adequate function of major organs as defined by the protocol.
* Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
* Sufficient blood samples must be provided during the screening period for genetic mutation testing.
Exclusion Criteria
* Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.
* Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.
* Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.
* Presence of factors that may affect drug administration, intake, or absorption.
* History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product.
* Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy.
* Presence of severe cardiovascular or cerebrovascular disease.
* Active, uncontrolled infection.
* Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.
* History of other malignancies within 5 years prior to the first administration of the investigational medicinal product.
* Presence of moderate to severe pulmonary disease that significantly impairs lung function.
* For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.
18 Years
MALE
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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QLC5508-202
Identifier Type: -
Identifier Source: org_study_id
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