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This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH56 Capsule Group | Experimental | Participants will be randomized to receive one of 6 active dose levels of GH56 orally (PO) daily (QD) in 21 days cycles. The study will determine the recommended dose of expansion (RDEs) and RP2D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GH56 Capsule | Drug | GH56 capsule for oral administration at specified doses on scheduled days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56. | MTD is the highest dose of a treatment that does not cause unacceptable side effects. RDEs stand for Recommended Dose for Expansion. | Approximately 3 years |
| Characterize the Safety of GH56 | Number of participants with treatment-emergent adverse events and serious AEs. | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years |
| Disease Control Rate (DCR) | Based on assessment of radiographic imaging per RECIST version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiming Zhou, Bachelor | Contact | +86-0512-86861608 | zhouyiming@genhousebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Approximately 3 years |
| Duration of Response (DOR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years |
| Progression-Free Survival (PFS) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years |
| Cmax | The maximum or "peak" concentration of GH56 observed after administration | Approximately 3 years |
| Tmax | The time to peak concentration of GH56 | Approximately 3 years |
| T1/2 | Half-life of GH56 | Approximately 3 years |
| PD of GH56 | Change of sDMA protein expression in tumor tissues | Approximately 3 years |
| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| Shanghai GoBroad Caner Hospital China Pharmaceutical University | Not yet recruiting | Shanghai | Shanghai Municipality | 201200 | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 30009 | China |
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