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This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | This Phase adopts an open-label design, with an Accelerated Titration(AT) design for the low-dose group (50 mg Bid) and the standard "3+3" design for the high-dose groups(100 mg Bid、50 mg Qd、100 mg Qd、200 mg Qd). |
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| Phase 2 Dose Expansion | Experimental | After the completion of the dose escalation study, RP2D will be selected for dose expansion in advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) with KRAS mutations that have failed at least the first-line standard treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG2001 Tosilate Tablets | Drug | ZG2001 will be administered orally once or twice daily in a continuous regimen |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out. | Up to 21 Days |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 | Up to 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Wei | Contact | +86-0512-57309965 | weic@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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