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This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.
Part One:
The plan involves including patients with previously failed standard treatments in advanced NSCLC and ES-SCLC. It consists of two phases: safety introduction and clinical expansion, covering cohorts 1 to 3.
The safety introduction phase will explore the safety of the following combined regimens in the target population:
Queue 1: JS212 + JS207 Queue 2: JS212 + Toripalimab Queue 3: JS212 + JS213
Part Two:
It is planned to include lung cancer patients who have not received any systemic anti-tumor treatment for advanced NSCLC and ES-SCLC in the past. If the SMC decides to further combine chemotherapy, the safety introduction phase should also include to ensure the safety of the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Queue 1: JS212 + JS207 | Experimental | JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS207 will be administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| Queue 2: JS212 + Toripalimab | Experimental | JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. Toripalimab will be administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| Queue 3: JS212 + JS213 | Experimental | JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS213 will be administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS212 for Injection | Drug | Administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(ORR), assessed by BICR (RECIST v1.1) | up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival (PFS), assessed by investigators (RECIST v1.1) | up to 6 years |
| DoR | Duration of response (DoR), assessed by BICR and investigators |
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Inclusion Criteria:
Exclusion Criteria:
1. Accompanying the following disease states:
2. Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:
3. Have received any of the following treatments:
4.Have not recovered to ≤ CTCAE grade 1 toxicity or the level specified in the inclusion/exclusion criteria.
5.Have known allergies to any study treatment or its excipients or have experienced an allergic reaction.
6.Have experienced a drug-related AE that led to permanent discontinuation of the anti-PD-(L)1 antibody treatment.
7.Have any of the following cardiac examination results:
8.Have a history of diagnosed or suspected ILD, drug-induced pneumonia, or other severe lung diseases.
9.Have experienced a severe infection within 4 weeks.
10.Have a history of immunodeficiency, or have a history of organ transplantation and allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
11.Have active pulmonary tuberculosis infection.
12.Have active hepatitis.
13. Uncontrolled concurrent diseases.
14. Participants who were diagnosed with any other malignant tumor within 5 years.
15. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
16. Other conditions for trial participation were not considered appropriate by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weilong Ni, Master | Contact | 18851101030 | weilong_ni@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| JS207 for Injection | Drug | Administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| Toripalimab | Drug | Administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| JS213 for Injection | Drug | Administered by intravenous infusion on Day 1 of each 21-day cycle. |
|
| up to 6 years |
| DCR | Disease control rate (DCR), assessed by BICR and investigators | up to 6 years |
| OS | overall survival (OS) | up to 6 years |
| Safety (AE) | Incidence and severity of adverse events (AEs) | up to 6 years |
| Number of Participants With Abnormal Laboratory Values or clinical findings | Abnormal laboratory or clinical findings | up to 6 years |
| dose-limiting toxicity(DLT) | Incidence and severity of dose-limiting toxicity(DLT) | up to 6 years |
| blood concentrations of JS212, JS207,toriplimab, or JS213 | Evaluation of blood concentrations of JS212, JS207,toriplimab, or JS213 | up to 2 years |
| ADA incidence | Incidence and titers of anti-drug antibodies (ADA) for JS212,JS207,toriplimab, or JS213; neutralizing antibodies (NAb) if applicable. | up to 4 years |