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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS5132 combined wtih bevacizumab | Experimental | QLS5132 in combination with bevacizumab |
|
| QLS5132 combined wtih platinum | Experimental | QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab |
|
| QLS5132 combined wtih Olaparib | Experimental | QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab |
|
| QLS5132 combined wtih immune checkpoint inhibitors | Experimental | QLS5132 in combination with immune checkpoint inhibitors |
|
| QLS5132 combined with immune checkpoint inhibitors and chemotherapy | Experimental | QLS5132 in combination with immune checkpoint inhibitors and chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS5132; Bevacizumab | Drug | Intravenous infusion,Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Incidence and severity of adverse events | 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 | From basline to Day 28 |
| Recommended Phase 2 Dose (RP2D) | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Zhu, PhD | Contact | +86 13858065156 | zhutao@zjcc.org.cn |
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| QLS5132; Platinum; Bevacizumab |
| Drug |
Intravenous infusion,Q3W |
|
| QLS5132; Olaparib; Bevacizumab | Drug | Olaparib is oral; all others are intravenous infusion,Q3W |
|
| QLS5132; QL1706; QL2107 | Drug | Intravenous infusion,Q3W |
|
| QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin | Drug | Intravenous infusion,Q3W |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D010984 | Platinum |
| C531550 | olaparib |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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