Advanced Prostate CancerPhase 1NCT07869888
A Study of QLS2401 Injection in Participants With Advanced Prostate Cancer
A Phase 1 study testing QLS2401 in people with Advanced Prostate Cancer, run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
Trial summary
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy 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
- Advanced Prostate Cancer
- What is being tested?
- QLS2401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2026to 30 Mar 2029
- Phase
- Phase 1
- 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
- Study participants enrolled voluntarily and signed an informed consent form. Male participants aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival time of at least 3 months.
- Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell carcinoma features.
- Metastatic prostate cancer confirmed by imaging.
- Belong to mCRPC.
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- Stage Ia participants with mCRPC who have failed or are intolerant to standard treatment.
- Stage I participants with mCRPC who have failed or are intolerant to standard treatment.
- 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).
- Prior to the first administration of the test drug, recover from all reversible adverse events (AEs) experienced during prior anticancer therapy.
Who cannot join
- Patients who have previously received any of the following treatments are eligible:
- Patients who have previously received targeted therapies targeting PSMA or STEAP1; for Stage Ia and Stage Ib Cohort 1, prior treatment with PSMA-targeted radionuclide ligand therapy (RLT) is permitted.
- Patients who have previously received T-cell conjugate (TCE)-based therapies; Subjects who have received other systemic small-molecule anticancer therapy within 2 weeks prior to the first dose of the investigational product, or macromolecular antitumor therapy within 28 days prior to the first dose of the investigational product, will be excluded, except for medications used to maintain castration status.
- Patients who have received traditional Chinese medicine for antineoplastic indications within 2 weeks prior to the first administration of the investigational drug; e) Patients currently receiving treatment with any drug known to prolong the QT interval or may precipitate torsades de pointes ventricular tachycardia, or who have received such drugs prior to the first administration without having reached the corresponding washout period.
- Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or metastatic spinal cord compression requiring hormonal therapy (at doses exceeding the physiological substitution dose) prior to the first administration of the investigational drug;
- Receipt of radiotherapy involving irradiation of more than 25% of the bone marrow within 4 weeks prior to the first administration of the investigational drug; or receipt of localized radiotherapy (excluding cranial radiotherapy) within 2 weeks prior to the first administration of the investigational drug;
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- Receipt of treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational drug (sufficient wound healing following major surgery must be clinically assessed); or planned bilateral orchiectomy during the study treatment period;
- History of epilepsy or occurrence of any condition that could trigger epileptic seizures within 12 months prior to the first administration of the investigational drug;
- Study participants with a history of psychotropic medication abuse, alcohol use disorder, or substance use disorder; or those with a documented history of neurological or psychiatric disorders that may contribute to poor treatment adherence.
- Has clinically significant cardiovascular or cerebrovascular disease.
- Administer a live attenuated vaccine within 4 weeks prior to the first dose of the investigational drug; or if administration of a live attenuated vaccine is anticipated during the study period.
- Pre-existing clinically uncontrolled third-space effusion prior to initial administration of the test drug.
- Previous history of hypertensive crisis or hypertensive encephalopathy.
- According to the investigator's judgment, the participant may pose an increased risk related to the study, potentially interfere with the interpretation of study results, or be deemed unsuitable for enrollment by the investigator.
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 I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLS2401 Injection in Participants With Advanced Prostate Cancer
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy in patients with advanced prostate cancer.
The Phase I trial is divided into Phase Ia and Phase Ib components. The Phase Ia component involves a dose-escalation study of QLS2401 as monotherapy; should the results from the Phase Ia study meet the predefined criteria, a Phase Ib efficacy-expansion study of QLS2401 as monotherapy will be conducted.
- Conditions
- Advanced Prostate Cancer
- Being tested
- QLS2401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS2401Drug
Participants will receive QLS2401 via intravenous (IV) or subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QLS2401 | Experimental | Once-Weekly administration; each 3-week period constitutes one treatment cycle (this may be adjusted based on preliminary study results) Receives: Drug: QLS2401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (Phase Ia)
MTD is determined based on the incidence of protocol-defined DLT during the first treatment cycle. Using the 3+3 dose-escalation design, MTD is defined as the highest dose level at which fewer than a predefined proportion of subjects experience DLT, while the next higher dose level exceeds the DLT threshold
Measured: From first dose of study treatment until the end of Cycle 1（each cycle is 21 days）
Maximum administered dose (MAD)(Phase Ia)
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: From first dose of study treatment until the end of Cycle 1（each cycle is 21 days）
Recommended phase II dose (RP2D) (Phase Ia)
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.
Measured: Through phase Ia completion, an average of 1 year
The incidence and severity of adverse events (AE) (Phase Ia)
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
Prostate-specific antigen (PSA) 50% response (PSA50 response)
Proportion of subjects with ≥ 50% PSA decrease
Measured: From Screening to confirmed progressive disease (approximately 1 year)
Objective response rate (ORR) (phase Ib)
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 posted13 Oct 2026
- Study start6 Nov 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869888
- Sponsor's protocol ID
- QLS2401-101
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLS2401 Injection in Participants With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07869888
- Acronym / sponsor ID
- QLS2401-101
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 13 Oct 2026 (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, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy in patients with advanced prostate cancer.
The Phase I trial is divided into Phase Ia and Phase Ib components. The Phase Ia component involves a dose-escalation study of QLS2401 as monotherapy; should the results from the Phase Ia study meet the predefined criteria, a Phase Ib efficacy-expansion study of QLS2401 as monotherapy will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS2401 | Experimental | Drug: QLS2401Once-Weekly administration; each 3-week period constitutes one treatment cycle (this may be adjusted based on preliminary study results) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Study participants enrolled voluntarily and signed an informed consent form. Male participants aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival time of at least 3 months.
- Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell carcinoma features.
- Metastatic prostate cancer confirmed by imaging.
Key exclusion criteria (14 listed)
- Patients who have previously received any of the following treatments are eligible:
- Patients who have previously received targeted therapies targeting PSMA or STEAP1; for Stage Ia and Stage Ib Cohort 1, prior treatment with PSMA-targeted radionuclide ligand therapy (RLT) is permitted.
- Patients who have previously received T-cell conjugate (TCE)-based therapies; Subjects who have received other systemic small-molecule anticancer therapy within 2 weeks prior to the first dose of the investigational product, or macromolecular antitumor therapy within 28 days prior to the first dose of the investigational product, will be excluded, except for medications used to maintain castration status.
- Patients who have received traditional Chinese medicine for antineoplastic indications within 2 weeks prior to the first administration of the investigational drug; e) Patients currently receiving treatment with any drug known to prolong the QT interval or may precipitate torsades de pointes ventricular tachycardia, or who have received such drugs prior to the first administration without having reached the corresponding washout period.
- Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or metastatic spinal cord compression requiring hormonal therapy (at doses exceeding the physiological substitution dose) prior to the first administration of the investigational drug;
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 |
|---|---|---|
| QLS2401Participants will receive QLS2401 via intravenous (IV) or subcutaneous injection | Drug | QLS2401 |
Primary outcome
Maximum tolerated dose (MTD) (Phase Ia)
Time frame: From first dose of study treatment until the end of Cycle 1（each cycle is 21 days）
MTD is determined based on the incidence of protocol-defined DLT during the first treatment cycle. Using the 3+3 dose-escalation design, MTD is defined as the highest dose level at which fewer than a predefined proportion of subjects experience DLT, while the next higher dose level exceeds the DLT threshold
Maximum administered dose (MAD)(Phase Ia)
Time frame: From first dose of study treatment until the end of Cycle 1（each cycle is 21 days）
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 Ia)
Time frame: Through phase Ia 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 Ia)
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
Prostate-specific antigen (PSA) 50% response (PSA50 response)
Time frame: From Screening to confirmed progressive disease (approximately 1 year)
Proportion of subjects with ≥ 50% PSA decrease
Objective response rate (ORR) (phase Ib)
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 13 Oct 2026.
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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 study testing QLS2401 in people with Advanced Prostate Cancer, run by Shanghai Qilu Pharmaceutical Research and Development Center 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 11 inclusion and 14 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 13 Oct 2026. 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 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.
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 Jinming Yu, Doctor (13806406293, sdyujinming@126.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 Ia) (time frame: From first dose of study treatment until the end of Cycle 1（each cycle is 21 days）). 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 13 Oct 2026.