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This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: JMKX001899+IN10018 | Experimental |
| |
| Cohort B: JMKX001899+chemotherapy | Experimental |
| |
| Cohort C: JMKX001899+IN10018+chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX001899 | Drug | JMKX001899 tablet administered orally daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase II dose (RP2D) | approximately 1 year | |
| adverse events | Through study completion, approximately 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieting Zhao | Contact | +86 13407649933 | zhaojieting@jemincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| IN10018 | Drug | IN10018 tablet administered orally daily. |
|
| Chemotherapy: Pemetrexed | Drug | IV infusion once every 3 weeks |
|
| Carboplatin | Drug | IV infusion once every 3 weeks, 4 Cycles |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |