Prostatic NeoplasmsPhase 1/2NCT07104110
Study of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer
A Phase 1/2 study testing QLH12016, abiraterone acetate and enzalutamide in people with Prostatic Neoplasms, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- QLH12016, abiraterone acetate and enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2028
- 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
- Signed the informed consent form.
- Male, aged ≥ 18 years.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic prostate cancer.
- Organ function meet protocol requirements.
- Recovered from all reversible AEs related to previous anticancer treatments.
Who cannot join
- Previous treatment with the following drugs:
- AR PROTAC class drugs.
- Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.
- Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.
- Drugs that may cause drug-drug interactions (DDI) with the study treatment.
- Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia
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- Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.
- Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product.
- Treatment with other investigational drugs or major surgery within 4 weeks.
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
- With severe cardiovascular or cerebrovascular diseases or related history.
- Active, uncontrolled infections.
- History of other significant malignancies within 5 years.
- Moderate to severe pulmonary disease significantly affecting lung function.
- According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study.
- Allergy to any of the investigational medicinal products or their components.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer
This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- QLH12016, abiraterone acetate, enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLH12016Drug
oral AR PROTAC
abiraterone acetateDrug
oral CYP17 inhibitor
enzalutamideDrug
oral androgen receptor inhibitor
| Study group | Role | What they receive |
|---|---|---|
| QLH12016+NHA | Experimental | Not described Receives: Drug: QLH12016; Drug: abiraterone acetate; Drug: enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with adverse events/serious adverse events (Phase Ib)
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
Measured: Throughout phase Ib (approximately 1 year)
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)
A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment.
Measured: From first dose of study treatment until the end of Cycle 1.
Recommended phase II dose (RP2D) (Phase Ib)
RP2D will be selected upon safety, PK and efficacy data.
Measured: Throughout phase Ib (approximately 1 year)
Objective Response Rate (ORR) (Phase II)
Best response until progression, as defined by RECIST 1.1 and PCWG3
Measured: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Objective Response Rate (ORR) (Phase II)
Proportion of subjects with ≥ 50% PSA decrease
Measured: From time of Informed Consent 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 posted5 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07104110
- Sponsor's protocol ID
- QLH12016-201
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. 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 Antitumor Activity of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07104110
- Acronym / sponsor ID
- QLH12016-201
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Aug 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 designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLH12016+NHA | Experimental | Drug: QLH12016, 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 (7 listed)
- Signed the informed consent form.
- Male, aged ≥ 18 years.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic prostate cancer.
Key exclusion criteria (16 listed)
- Previous treatment with the following drugs:
- Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.
- Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product.
- Treatment with other investigational drugs or major surgery within 4 weeks.
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and 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 |
|---|---|---|
| QLH12016oral AR PROTAC | Drug | QLH12016+NHA |
| abiraterone acetateoral CYP17 inhibitor | Drug | QLH12016+NHA |
| enzalutamideoral androgen receptor inhibitor | Drug | QLH12016+NHA |
Primary outcome
The number of subjects with adverse events/serious adverse events (Phase Ib)
Time frame: Throughout phase Ib (approximately 1 year)
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)
Time frame: From first dose of study treatment until the end of Cycle 1.
A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment.
Recommended phase II dose (RP2D) (Phase Ib)
Time frame: Throughout phase Ib (approximately 1 year)
RP2D will be selected upon safety, PK and efficacy data.
Objective Response Rate (ORR) (Phase II)
Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Best response until progression, as defined by RECIST 1.1 and PCWG3
Objective Response Rate (ORR) (Phase II)
Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year).
Proportion of subjects with ≥ 50% PSA decrease
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 5 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLH12016, abiraterone acetate and enzalutamide in people with Prostatic Neoplasms, run by Qilu Pharmaceutical Co., Ltd..
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Wanhai Xu, PHD (0451-86605612, xuwanhai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with adverse events/serious adverse events (Phase Ib) (time frame: Throughout phase Ib (approximately 1 year)). The study lists 5 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 5 Aug 2025.