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This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation phase | Experimental | Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD) |
|
| Dose expansion phase | Experimental | Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-30355 | Drug | Oral administration |
| |
| JAB-30355 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Number and proportion of participants who experience at least one dose limiting toxicity (DLT) | Approximately one year |
| Number of participants with adverse events | All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al. | Approximately three years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters. | Approximately three years |
| Time to reach the observed maximum (peak) concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacobio Pharmaceuticals | Contact | 781-918-6670 | clinicaltrials@jacobiopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Denver | Colorado | 80218 | United States | |
| Research site |
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| Drug |
Oral administration |
|
Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters. |
| Approximately three years |
| Terminal half-life (t1/2) | Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters. | Approximately three years |
| Objective response rate (ORR) | ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Approximately three years |
| Duration of response (DOR) | DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1. | Approximately three years |
| Terminated |
| Lake Mary |
| Florida |
| 32771 |
| United States |
| Research site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research site | Terminated | Canton | Ohio | 44718 | United States |
| Research site | Recruiting | Cleveland | Ohio | 44195 | United States |
| Research Site | Recruiting | Nashville | Tennessee | 37203 | United States |
| Research site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Research Site | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| Research Site | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| Research Site | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Research Site | Recruiting | Zhengzhou | Henan | 451191 | China |
| Research Site | Recruiting | Shenyang | Liaoning | 110801 | China |
| Research Site | Recruiting | Jinan | Shandong | 250117 | China |
| Research Site | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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