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This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma | Experimental | Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HG146 | Drug | HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | ORR will be assessed by the investigators using RECIST v1.1 | From enrollment to the end of treatment at 4 weeks |
| 6 Months Progression-Free Survival (PFS) | PFS will be assessed by the investigators using RECIST v. 1.1 | From enrollment to treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS will be assessed by the investigators using RECIST v1.1 | From enrollment to treatment at 12 months |
| Duration of response (DoR) | DOR will be assessed by the investigators using RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Shen | Contact | 8268-85197385 | 8211 | jie.shen@hitgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Guo | Shanghai Oriental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Oriental Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| From enrollment to the end of treatment at 4 weeks |
| Disease control rate (DCR) | DCR will be assessed by the investigators using RECIST v1.1 | From enrollment to the end of treatment at 4 weeks |
| Overall survival (OS) | OS will be assessed by the investigators | From enrollment to the end of treatment at 4 weeks |
| Time-to-response (TTR) | TTR will be assessed by the investigators using RECIST v1.1 | From enrollment to the end of treatment at 4 weeks |
| Population pharmacokinetics (PopPK) | PopPK will be detected to predict exposure level of HG146 in human body. | From Cycle1 Day7 to Day13, 21 days per cycle |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |