Gastric Cancer (GC)Phase 1/2NCT07453394
QLS5132 Combination Therapy in Advanced Solid Tumors
A Phase 1/2 study testing QLS5132; Bevacizumab, QLS5132; Platinum; Bevacizumab and QLS5132; Olaparib; Bevacizumab in people with Gastric Cancer (GC) and Non-small Cell Lung Cancer (NSCLC), run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Non-small Cell Lung Cancer (NSCLC), Endometrial Cancer
- What is being tested?
- QLS5132; Bevacizumab, QLS5132; Platinum; Bevacizumab and QLS5132; Olaparib; Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Feb 2029
- 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
- Advanced solid tumors;
- Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (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 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.
Who cannot join
- Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates [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;
Show all 10Show fewer
- History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
- History of a second primary malignancy;
- If female, is pregnant or breastfeeding;
- Be allergic to any component of QLS5132 or its excipients.
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 Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.
The main questions it aims to answer are:
Read more
- In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?
- In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?
Participants will:
- Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.
- Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.
- Conditions
- Gastric Cancer (GC), Non-small Cell Lung Cancer (NSCLC), Endometrial Cancer, Advanced Solid Tumors, Ovarian Cancer
- Being tested
- QLS5132; Bevacizumab, QLS5132; Platinum; Bevacizumab, QLS5132; Olaparib; Bevacizumab, QLS5132; QL1706; QL2107, QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin
- Keywords
- CLDN6 ADC
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5132; BevacizumabDrug
Intravenous infusion，Q3W
QLS5132; Platinum; BevacizumabDrug
Intravenous infusion，Q3W
QLS5132; Olaparib; BevacizumabDrug
Olaparib is oral; all others are intravenous infusion，Q3W
QLS5132; QL1706; QL2107Drug
Intravenous infusion，Q3W
QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; OxaliplatinDrug
Intravenous infusion，Q3W
| Study group | Role | What they receive |
|---|---|---|
| QLS5132 combined wtih bevacizumab | Experimental | QLS5132 in combination with bevacizumab Receives: Drug: QLS5132; Bevacizumab |
| QLS5132 combined wtih platinum | Experimental | QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab Receives: Drug: QLS5132; Platinum; Bevacizumab |
| QLS5132 combined wtih Olaparib | Experimental | QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab Receives: Drug: QLS5132; Olaparib; Bevacizumab |
| QLS5132 combined wtih immune checkpoint inhibitors | Experimental | QLS5132 in combination with immune checkpoint inhibitors Receives: Drug: QLS5132; QL1706; QL2107 |
| QLS5132 combined with immune checkpoint inhibitors and chemotherapy | Experimental | QLS5132 in combination with immune checkpoint inhibitors and chemotherapy Receives: Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Incidence and severity of adverse events
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: From basline to Day 28
Recommended Phase 2 Dose (RP2D)
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 posted6 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 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
- NCT07453394
- Sponsor's protocol ID
- QLS5132-201
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 6 Mar 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07453394
- Acronym / sponsor ID
- QLS5132-201
- Conditions
- Gastric Cancer (GC), Non-small Cell Lung Cancer (NSCLC), Endometrial Cancer, Advanced Solid Tumors, Ovarian Cancer
- Keywords
- CLDN6 ADC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 6 Mar 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.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.
The main questions it aims to answer are:
- In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?
- In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?
Participants will:
- Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.
- Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| QLS5132 combined wtih bevacizumab | Experimental | Drug: QLS5132; BevacizumabQLS5132 in combination with bevacizumab |
| QLS5132 combined wtih platinum | Experimental | Drug: QLS5132; Platinum; BevacizumabQLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab |
| QLS5132 combined wtih Olaparib | Experimental | Drug: QLS5132; Olaparib; BevacizumabQLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab |
| QLS5132 combined wtih immune checkpoint inhibitors | Experimental | Drug: QLS5132; QL1706; QL2107QLS5132 in combination with immune checkpoint inhibitors |
| QLS5132 combined with immune checkpoint inhibitors and chemotherapy | Experimental | Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; OxaliplatinQLS5132 in combination with immune checkpoint inhibitors and chemotherapy |
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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (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 National Cancer Institute-Common Terminology Criteria for Adverse Events [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 antibody-drug conjugates [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 |
|---|---|---|
| QLS5132; BevacizumabIntravenous infusion，Q3W | Drug | QLS5132 combined wtih bevacizumab |
| QLS5132; Platinum; BevacizumabIntravenous infusion，Q3W | Drug | QLS5132 combined wtih platinum |
| QLS5132; Olaparib; BevacizumabOlaparib is oral; all others are intravenous infusion，Q3W | Drug | QLS5132 combined wtih Olaparib |
| QLS5132; QL1706; QL2107Intravenous infusion，Q3W | Drug | QLS5132 combined wtih immune checkpoint inhibitors |
| QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; OxaliplatinIntravenous infusion，Q3W | Drug | QLS5132 combined with immune checkpoint inhibitors and chemotherapy |
Primary outcome
Incidence and severity of adverse events
Time frame: up to 2 years
Incidence and severity of adverse events
Maximum tolerated dose (MTD)
Time frame: From basline to Day 28
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
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 6 Mar 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 1/2 study testing QLS5132; Bevacizumab, QLS5132; Platinum; Bevacizumab and QLS5132; Olaparib; Bevacizumab in people with Gastric Cancer (GC) and Non-small Cell Lung Cancer (NSCLC), 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 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 6 Mar 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 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 Tao Zhu, PhD (+86 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 (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 6 Mar 2026.