Advanced Solid TumorsPhase 1NCT06932094
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
A Phase 1 study testing QLS5132 in people with Advanced Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion): Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels. 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?
- QLS5132
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- May 2025to Feb 2028
- 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
- Advanced solid tumors;
- Measurable disease, per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- 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;
Who cannot join
- Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
- Progressive or symptomatic brain metastases;
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
- 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 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 QLS5132 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.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):
- Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
- Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1~3 selected dose levels follow successful Phase 1a results.
- Conditions
- Advanced Solid Tumors
- Being tested
- QLS5132
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5132Drug
antibody drug conjugate (ADC).
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding and Expansion- QLS5132 Monotherapy | Experimental | Intravenous infusion，Q3W Receives: Drug: QLS5132 |
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
Secondary outcomes (17)
Maximum Serum Concentration of QLS5132 (Cmax)
PK assessment
Measured: 21 days
Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)
PK assessment
Measured: 63 days
Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)
PK assessment
Measured: 63 days
Time of Maximum Serum Concentration of QLS5132 (Tmax)
PK assessment
Measured: 21 days
Terminal Half-life (T1/2) of Serum QLS5132
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 QLS5132
PK assessment
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132
PK assessment
Measured: 63 days
Volume of Distribution (Vd) of QLS5132
PK assessment
Measured: 63 days
Clearance (CL) of QLS5132
PK assessment
Measured: 63 days
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
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: up to 2 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 posted17 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionFeb 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 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
- NCT06932094
- Sponsor's protocol ID
- QLS5132-101
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 23 Apr 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06932094
- Acronym / sponsor ID
- QLS5132-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Apr 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 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):
- Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
- Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1~3 selected dose levels follow successful Phase 1a results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Finding and Expansion- QLS5132 Monotherapy | Experimental | Drug: QLS5132Intravenous infusion，Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced solid tumors;
- Measurable disease, per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- 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;
Key exclusion criteria (10 listed)
- Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
- Progressive or symptomatic brain metastases;
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
- 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 |
|---|---|---|
| QLS5132antibody drug conjugate (ADC). | Drug | Dose Finding and Expansion- QLS5132 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
17 secondary outcomes
Maximum Serum Concentration of QLS5132 (Cmax)
Time frame: 21 days
Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)
Time frame: 63 days
Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)
Time frame: 63 days
Time of Maximum Serum Concentration of QLS5132 (Tmax)
Time frame: 21 days
Terminal Half-life (T1/2) of Serum QLS5132
Time frame: 63 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5132
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132
Time frame: 63 days
Volume of Distribution (Vd) of QLS5132
Time frame: 63 days
Clearance (CL) of QLS5132
Time frame: 63 days
Objective Response Rate (ORR)
Time frame: up to 2 years
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: up to 2 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 23 Apr 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 study testing QLS5132 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 5 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 23 Apr 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 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 Tao Zhu, PhD (13858065156, zhutao@zjcc.org.cn), 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 3 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 23 Apr 2025.