Advanced Solid TumorsPhase 1/2NCT07061639
A Study of QLS5133 Monotherapy in Advanced Solid Tumors
A Phase 1/2 study testing QLS5133 in people with Advanced Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion： Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. 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?
- QLS5133
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years on the day of signing the ICF, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
- Measurable disease, per RECIST v1.1;
- Adequate organ function;
- Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
Who cannot join
- Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
- Progressive or symptomatic brain metastases;
- Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
- History of significant cardiac disease, or poorly controlled diabetes mellitus;
- History of recurrent autoimmune diseases;
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- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- History of other active malignant tumors within 3 years before signing the informed consent form;
- If female, is pregnant or breastfeeding;
- Be allergic to any component of QLS5133 or its excipients.
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
Fudan University Shanghai Cancer Center
Shanghai
Xiaohua Wu, 021-64175590-88503, JJYIN555@163.com
About this study
Official title: A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion：
- Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion.
- Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.
- Conditions
- Advanced Solid Tumors
- Being tested
- QLS5133
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5133Drug
antibody drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Finding | Experimental | Not described Receives: Drug: QLS5133 |
| PK expansion as Monotherapy | Experimental | Not described Receives: Drug: QLS5133 |
| Cohort expansion as Monotherapy | Experimental | Not described Receives: Drug: QLS5133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Measured: up to 2 years
Maximum tolerated dose (MTD)
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Measured: 28days
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Measured: up to 2 years
Objective Response Rate (ORR)
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: up to 2 years
Secondary outcomes (16)
Maximum Serum Concentration of QLS5133 (Cmax)
PK assessment
Measured: 21 days
Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss)
PK assessment
Measured: 63 days
Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss)
PK assessment
Measured: 63 days
Time of Maximum Serum Concentration of QLS5133 (Tmax)
PK assessment
Measured: 21 days
Terminal Half-life (T1/2) of Serum QLS5133
PK assessment
Measured: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133
PK assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133
PK assessment
Measured: 63 days
Apparent Volume of Distribution (Vd) of QLS5133
PK assessment
Measured: 63 days
Clearance (CL) of QLS5133
PK assessment
Measured: 63 days
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Measured: up to 2 years
Progression Free Survival (PFS)
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Measured: up to 2 years
Time to Progression (TTP)
Time from start of treatment to disease progression
Measured: 1 years
1 Year Overall Survival (1YOS)
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Measured: 1 years
2 Year Overall Survival (2YOS)
Proportion of participants alive at 2 years from the start of treatment to death from any cause
Measured: 2 years
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive
Measured: up to 2 years
Number of neutralizing antibody (Nab) Positive Participants
Immunogenicity will be measured by the number of participants that are Nab positive
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionApr 2028 (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.
- 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
- Sequential
- 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
- NCT07061639
- Sponsor's protocol ID
- QLS5133-101
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 11 Jul 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 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07061639
- Acronym / sponsor ID
- QLS5133-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Jul 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.
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion：
- Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion.
- Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Finding | Experimental | Drug: QLS5133 |
| PK expansion as Monotherapy | Experimental | Drug: QLS5133 |
| Cohort expansion as Monotherapy | Experimental | Drug: QLS5133 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years on the day of signing the ICF, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
- Measurable disease, per RECIST v1.1;
- Adequate organ function;
- Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
Key exclusion criteria (10 listed)
- Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
- Progressive or symptomatic brain metastases;
- Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
- History of significant cardiac disease, or poorly controlled diabetes mellitus;
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 |
|---|---|---|
| QLS5133antibody drug conjugate (ADC) | Drug | Cohort expansion as Monotherapy, Monotherapy Dose Finding, PK expansion as Monotherapy |
Primary outcome
Incidence and severity of adverse events and serious adverse events
Time frame: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Maximum tolerated dose (MTD)
Time frame: 28days
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
Time frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Objective Response Rate (ORR)
Time frame: up to 2 years
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
16 secondary outcomes
Maximum Serum Concentration of QLS5133 (Cmax)
Time frame: 21 days
Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss)
Time frame: 63 days
Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss)
Time frame: 63 days
Time of Maximum Serum Concentration of QLS5133 (Tmax)
Time frame: 21 days
Terminal Half-life (T1/2) of Serum QLS5133
Time frame: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133
Time frame: 63 days
Apparent Volume of Distribution (Vd) of QLS5133
Time frame: 63 days
Clearance (CL) of QLS5133
Time frame: 63 days
Duration of Response (DOR)
Time frame: up to 2 years
Progression Free Survival (PFS)
Time frame: up to 2 years
Time to Progression (TTP)
Time frame: 1 years
1 Year Overall Survival (1YOS)
Time frame: 1 years
2 Year Overall Survival (2YOS)
Time frame: 2 years
Number of anti-drug antibody (ADA) Positive Participants
Time frame: up to 2 years
Number of neutralizing antibody (Nab) Positive Participants
Time frame: up to 2 years
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 11 Jul 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.
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 QLS5133 in people with Advanced Solid Tumors, 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 6 inclusion and 10 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 11 Jul 2025. 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 Xiaohua Wu, PhD (021-64175590-88503, JJYIN555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events and serious adverse events (time frame: 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 11 Jul 2025.