Advanced Solid TumorsPhase 1NCT07915856
A Study of QLS5314 Monotherapy in Participants With Advanced Solid Tumors
A Phase 1 study testing QLS5314 in people with Advanced Solid Tumors, run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
Trial summary
This Phase 1, first-in-human, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QLS5314 monotherapy in adults with advanced solid tumors. The study includes Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b efficacy expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- QLS5314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2027to 26 Oct 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥18 years who voluntarily provide written informed consent.
- Histologically or cytologically confirmed advanced solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a life expectancy of ≥3 months.
- At least one measurable lesion according to RECIST v1.1.
- Availability of tumor tissue for biomarker testing, as required by the protocol.
- Adequate hematologic, hepatic, renal, coagulation, and cardiac function as defined in the protocol, including left ventricular ejection fraction (LVEF) ≥50%.
- Recovery from adverse events associated with prior anticancer therapy to Grade ≤1, except as otherwise permitted by the protocol.
- Willingness to comply with protocol-specified contraception requirements; women of childbearing potential must have a negative pregnancy test and must not be breastfeeding.
Who cannot join
- Prior treatment with any LY6G6D-targeting agent or an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor (TOP1i) payload.
- Receipt of anticancer therapy within the protocol-defined washout periods before the first dose of QLS5314.
- Uncontrolled or symptomatic central nervous system metastases, leptomeningeal metastases, or metastatic spinal cord compression, except as permitted by the protocol.
- Uncontrolled pleural, pericardial, or peritoneal effusion, or another active malignancy not meeting the protocol-defined exceptions.
- Clinically significant cardiovascular or cerebrovascular disease, uncontrolled hypertension, clinically significant arrhythmias, or QT interval prolongation.
- Poorly controlled diabetes mellitus or other clinically significant uncontrolled metabolic conditions.
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- Active or recurrent autoimmune disease, or recent systemic corticosteroid or immunosuppressive therapy not meeting the protocol-defined exceptions.
- Human immunodeficiency virus (HIV) positivity, hepatitis B or C infection meeting the protocol-defined exclusion thresholds, or active infection requiring systemic anti-infective treatment.
- Clinically significant bleeding, recent serious thromboembolic events, or other conditions associated with an increased risk of bleeding or thrombosis.
- History or presence of interstitial lung disease, radiation pneumonitis, severe pulmonary dysfunction, or other conditions that may interfere with the assessment or management of drug-related pulmonary toxicity.
- Known severe hypersensitivity to QLS5314 or its components, or a history of severe infusion-related reactions.
- Any other serious medical or psychiatric condition or laboratory abnormality that, in the investigator's opinion, would make participation unsuitable.
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: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of QLS5314 Monotherapy in Participants With Advanced Solid Tumors
This Phase 1, first-in-human, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QLS5314 monotherapy in adults with advanced solid tumors. The study includes Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b efficacy expansion. It also aims to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose (RP2D).
- Conditions
- Advanced Solid Tumors
- Being tested
- QLS5314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5314Drug
QLS5314 is an investigational LY6G6D-targeted antibody-drug conjugate with an exatecan topoisomerase I inhibitor payload. It is administered by intravenous infusion every 3 weeks at protocol-specified dose levels (initially planned as 0.5, 2.0, 4.0, 6.0 and 8.0 mg/kg). Dose and dosing frequency may be adjusted according to study data and SMC review.
| Study group | Role | What they receive |
|---|---|---|
| QLS5314 Monotherapy | Experimental | Not described Receives: Drug: QLS5314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Incidence and Severity of Adverse Events
Number and percentage of participants with adverse events (AEs), treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs) and serious AEs (SAEs), by severity graded according to NCI-CTCAE v6.0 and relationship to QLS5314.
Measured: From informed consent through 30 days (±7 days) after the last dose; treatment for up to 2 years.
Incidence of Dose-Limiting Toxicities (DLTs)
Number and percentage of participants with protocol-defined DLTs during the Phase 1a dose-escalation stage.
Measured: Cycle 1 Days 1-21 following first administration of QLS5314.
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
MTD established using protocol-defined dose-escalation rules, or MAD if an MTD is not established.
Measured: From the first dose until completion of Phase Ia dose escalation, up to approximately 11 months.
Recommended Phase 2 Dose (RP2D)
RP2D determined using cumulative safety, tolerability, pharmacokinetic, immunogenicity, pharmacodynamic, biomarker and preliminary efficacy data.
Measured: From the first dose until determination of the RP2D, up to approximately 20 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start26 Jan 2027 (estimated)
- Primary completion2 Oct 2029 (estimated)
- Study completion26 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 70 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
- NCT07915856
- Sponsor's protocol ID
- QLS5314-101
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of QLS5314 Monotherapy in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07915856
- Acronym / sponsor ID
- QLS5314-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2027 (estimated)
- Primary completion
- 2 Oct 2029 (estimated)
- Study completion
- 26 Oct 2029 (estimated)
- First posted
- 4 Nov 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 Phase 1, first-in-human, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QLS5314 monotherapy in adults with advanced solid tumors. The study includes Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b efficacy expansion. It also aims to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS5314 Monotherapy | Experimental | Drug: QLS5314 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants aged ≥18 years who voluntarily provide written informed consent.
- Histologically or cytologically confirmed advanced solid tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a life expectancy of ≥3 months.
- At least one measurable lesion according to RECIST v1.1.
- Availability of tumor tissue for biomarker testing, as required by the protocol.
Key exclusion criteria (12 listed)
- Prior treatment with any LY6G6D-targeting agent or an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor (TOP1i) payload.
- Receipt of anticancer therapy within the protocol-defined washout periods before the first dose of QLS5314.
- Uncontrolled or symptomatic central nervous system metastases, leptomeningeal metastases, or metastatic spinal cord compression, except as permitted by the protocol.
- Uncontrolled pleural, pericardial, or peritoneal effusion, or another active malignancy not meeting the protocol-defined exceptions.
- Clinically significant cardiovascular or cerebrovascular disease, uncontrolled hypertension, clinically significant arrhythmias, or QT interval prolongation.
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 |
|---|---|---|
| QLS5314QLS5314 is an investigational LY6G6D-targeted antibody-drug conjugate with an exatecan topoisomerase I inhibitor payload. It is administered by intravenous infusion every 3 weeks at protocol-specified dose levels (initially planned as 0.5, 2.0, 4.0, 6.0 and 8.0 mg/kg). Dose and dosing frequency may be adjusted according to study data and SMC review. | Drug | QLS5314 Monotherapy |
Primary outcome
Safety and Tolerability: Incidence and Severity of Adverse Events
Time frame: From informed consent through 30 days (±7 days) after the last dose; treatment for up to 2 years.
Number and percentage of participants with adverse events (AEs), treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs) and serious AEs (SAEs), by severity graded according to NCI-CTCAE v6.0 and relationship to QLS5314.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 Days 1-21 following first administration of QLS5314.
Number and percentage of participants with protocol-defined DLTs during the Phase 1a dose-escalation stage.
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Time frame: From the first dose until completion of Phase Ia dose escalation, up to approximately 11 months.
MTD established using protocol-defined dose-escalation rules, or MAD if an MTD is not established.
Recommended Phase 2 Dose (RP2D)
Time frame: From the first dose until determination of the RP2D, up to approximately 20 months.
RP2D determined using cumulative safety, tolerability, pharmacokinetic, immunogenicity, pharmacodynamic, biomarker and preliminary efficacy data.
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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 QLS5314 in people with Advanced Solid Tumors, 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 8 inclusion and 12 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 4 Nov 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 Han Liu, Bachelor (+86 17721196398, han4.liu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Incidence and Severity of Adverse Events (time frame: From informed consent through 30 days (±7 days) after the last dose; treatment for up to 2 years.). The study lists 4 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 4 Nov 2026.