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| Name | Class |
|---|---|
| InxMed (Shanghai) Co., Ltd. | INDUSTRY |
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This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b Dose escalation of D-1553 plus IN10018 | Experimental | Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation. |
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| Phase 2 Doseexpansion of D-1553 plus IN10018 | Experimental | Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-1553 | Drug | D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Number of subjects participants with adverse events | Through study completion, approximately 3 years |
| Objective response rate (ORR) per RECIST v1.1 | Defined as the proportion of patients with complete response (CR) or partial response (PR). | Through study completion, approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Subject with unstable or progressive central nervous system (CNS) metastases.
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| Name | Affiliation | Role |
|---|---|---|
| Zhengbo Song | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences, | Hangzhou | Zhejiang | 310005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42413526 | Derived | Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print. |
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| IN10018 | Drug | IN10018 orally once daily at approximately the same time each day |
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