Advanced Prostate CancerPhase 1/2NCT07198633
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
A Phase 1/2 study testing QLC5508, abiraterone acetate and enzalutamide in people with Advanced Prostate Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- QLC5508, abiraterone acetate and enzalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2025to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily agrees to participate and has signed the informed consent form.
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Xin Yao, Doctor, 86 022-23340123-2123, yaoxin@tjmuch.com
About this study
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.
The study consists of two stages:
Read more
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.
- Conditions
- Advanced Prostate Cancer
- Being tested
- QLC5508, abiraterone acetate, enzalutamide, QLH12016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC5508Drug
B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.
abiraterone acetateDrug
An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol
enzalutamideDrug
An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.
QLH12016Drug
An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol
| Study group | Role | What they receive |
|---|---|---|
| QLC5508+NHA | Experimental | Not described Receives: Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide |
| QLC5508+QLH12016 | Experimental | Not described Receives: Drug: QLC5508; Drug: QLH12016 |
| QLC5508+QLH12016+NHA | Experimental | Not described Receives: Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide; Drug: QLH12016 |
| QLH12016+NHA | Experimental | Not described Receives: Drug: QLC5508; Drug: abiraterone acetate; Drug: enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (Phase Ib)
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT
Measured: At the end of Day 28 after the first dose
Maximum administered dose (MAD)(Phase Ib)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Measured: At the end of Day 28 after the first dose
recommended phase II dose (RP2D) (Phase Ib)
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.
Measured: Through phase Ib completion, an average of 1 year.
The incidence and severity of adverse events (AE) (Phase Ib)
Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0
Measured: Through phase Ib completion, an average of 1 year.
PSA50 response（Phase II）
Proportion of subjects with ≥ 50% PSA decrease
Measured: From Screening to confirmed progressive disease (approximately 1 year)
Objective response rate (ORR) (phase II)
Best response until progression, as defined by RECIST 1.1 and PCGW3.
Measured: From Screening to confirmed progressive disease (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start5 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198633
- Sponsor's protocol ID
- QLC5508-202
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07198633
- Acronym / sponsor ID
- QLC5508-202
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLC5508+NHA | Experimental | Drug: QLC5508, Drug: abiraterone acetate, Drug: enzalutamide |
| QLC5508+QLH12016 | Experimental | Drug: QLC5508, Drug: QLH12016 |
| QLC5508+QLH12016+NHA | Experimental | Drug: QLC5508, Drug: abiraterone acetate, Drug: enzalutamide, Drug: QLH12016 |
| QLH12016+NHA | Experimental | Drug: QLC5508, Drug: abiraterone acetate, Drug: enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject voluntarily agrees to participate and has signed the informed consent form.
- 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.
Key exclusion criteria (13 listed)
- Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLC5508B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol. | Drug | QLC5508+NHA, QLC5508+QLH12016, QLC5508+QLH12016+NHA, QLH12016+NHA |
| abiraterone acetateAn oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol | Drug | QLC5508+NHA, QLC5508+QLH12016+NHA, QLH12016+NHA |
| enzalutamideAn oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol. | Drug | QLC5508+NHA, QLC5508+QLH12016+NHA, QLH12016+NHA |
| QLH12016An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol | Drug | QLC5508+QLH12016, QLC5508+QLH12016+NHA |
Primary outcome
Maximum tolerated dose (MTD) (Phase Ib)
Time frame: At the end of Day 28 after the first dose
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT
Maximum administered dose (MAD)(Phase Ib)
Time frame: At the end of Day 28 after the first dose
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
recommended phase II dose (RP2D) (Phase Ib)
Time frame: Through phase Ib completion, an average of 1 year.
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.
The incidence and severity of adverse events (AE) (Phase Ib)
Time frame: Through phase Ib completion, an average of 1 year.
Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0
PSA50 response（Phase II）
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Proportion of subjects with ≥ 50% PSA decrease
Objective response rate (ORR) (phase II)
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Best response until progression, as defined by RECIST 1.1 and PCGW3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Related trials for Advanced Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Biochemically Recurrent Prostate Carcinoma, Locally Advanced Prostate Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLC5508, abiraterone acetate and enzalutamide in people with Advanced Prostate Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yao, PHD (18622221103, yaoxin@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (Phase Ib) (time frame: At the end of Day 28 after the first dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.