A Phase 1/2 interventional study of QLS5133; Lenvatinib mesylate and QLS5133; QL2107; Lenvatinib mesylate in Clear Cell Renal Cell Carcinoma, Ovarian Cancer and Other Advanced Solid Tumors, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment
Among 234 studies in Carcinoma, Renal Cell with a site in China — 111 open to participants now, 142 under way, 10 of them phase 3. Carcinoma, Renal Cell · China.
Among the 234 studies in Carcinoma, Renal Cell with a site in China, this one is the 10th largest by planned enrollment of the 189 interventional ones that give a count, is one of 31 that started in 2026, is one of 24 in phase 1/2, reaches primary completion later than 96 of the 141 other live ones, and was the 234th registered.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →111 of the 234 studies in Carcinoma, Renal Cell with a site in China are open now. Recruiting first, the newest first:
Huazhong University of Science and Technology · Sites in China
Ages 18–80
Zhongnan Hospital · Sites in China
Ages 18+ · Healthy volunteers
RenJi Hospital · Sites in China
Ages 18+
Hangzhou Huasai Biomedicine Co., Ltd. · Sites in China
Ages 18–75
Hebei Medical University Fourth Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 308 Carcinoma, Renal Cell studies recruiting now, 255 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
234 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 64 · Phase 2 93 · Phase 3 23 · Phase 4 1
First in 2005; this study’s year is marked. 31 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 558 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Median enrollment 66 across the 189 interventional studies, 300 across the 45 observational. Of the 57 that completed or were terminated, 14 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
75 of 234 have an industry lead sponsor. The 10 most frequent:
Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 200 studies on the registry; 122 are open to participants now.
Qilu Pharmaceutical Co., Ltd. has 2 studies filed under Carcinoma, Renal Cell — fewer than ten, so there is no comparison to draw.
35 of the studies in Carcinoma, Renal Cell with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03592472Phase 3Xynomic Pharmaceuticals, Inc.A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) | 2026-12-30 |
| NCT07881900Phase 3Sun Yat-sen UniversityBenmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma | 2027-06-30 |
| NCT06680089RenJi HospitalCD70-targeted immunoPET Imaging of Kidney Cancer | 2026-11 |
| NCT050242143D Medicines (Sichuan) Co., Ltd.Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors | 2026-12 |
| NCT06852638RenJi HospitalCD70-targeted immunoPET Imaging of Malignant Cancers | 2026-12-23 |
Add all 35 to your calendar (.ics) → With an account.
Among the 234 studies in Carcinoma, Renal Cell with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5133 (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:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QLS5133 in combination with lenvatinib mesylate
Drug: QLS5133; Lenvatinib mesylate
QLS5133 in combination with lenvatinib mesylate plus QL2107
Drug: QLS5133; QL2107; Lenvatinib mesylate
QLS5133 in combination with bevacizumab
Drug: QLS5133; Bevacizumab
QLS5133 in combination with platinum-based therapy with or without bevacizumab, followed by QLS5133 alone or in combination with bevacizumab
Drug: QLS5133; Platinum; Bevacizumab
QLS5133 in combination with olaparib with or without bevacizumab
Drug: QLS5133; Olaparib; Bevacizumab
QLS5133 in combination with QL2107 with or without bevacizumab
Drug: QLS5133; QL2107; Bevacizumab
QLS5133: Intravenous infusion, Q3W; Lenvatinib mesylate: Oral, once daily
QLS5133 and QL2107: Intravenous infusion, Q3W; Lenvatinib mesylate: Oral, once daily
Intravenous infusion，Q3W
Intravenous infusion，Q3W
Olaparib is oral; all others are intravenous infusion，Q3W
Intravenous infusion，Q3W
Phase Ib Outcome 1:Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 6.0
Time frame: up to 2 years
Phase Ib Outcome 2:Maximum tolerated dose (MTD)
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Time frame: 28 days
Phase Ib Outcome 3:Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Time frame: up to 2 years
Phase II outcome 1:Objective response rate (ORR) (Arms 1B, 2B, 3B-3, 4B, 6B)
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
Time frame: up to 2 years
Phase II outcome 2:Progression-free survival (PFS) (Arms 3B-1, 3B-2, and 5B)
PFS is defined as the duration from the date of first dose of study treatment to the date of first documented PD per investigator assessment, or death from any cause, whichever occurs first.
Time frame: up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 70 industry-sponsored phase 1/2 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 78. This study's planned 12 months is below that.
Counting every sponsor, half of 111 studies reached it within 64 months; a quarter within 45 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd. →