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This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).
This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - dose escalation | Experimental | Dose escalation of KNT-0916 in patients with advanced solid tumors. |
|
| Part B - expansion | Experimental | Oral dose of KNT-0916 as determined during Part A Dose Escalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KNT-0916 | Drug | • KNT-0916 is an oral inhibitor of FGFR2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity (DLT) | 4 weeks | |
| Maximum tolerated dose (MTD) or Maximum administered dose (MAD) | 12 months | |
| Incidence, relatedness, seriousness and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) Version 5.0. | 33 months | |
| Recommended phase 2 dose (RP2D) | 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 33 months | |
| Duration of response (DoR) assessed as per RECIST 1.1 | 33 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li | Contact | +86 13711344347 | lilei@kino-biotech.com | |
| Shaohua Chang | Contact | 0086-13621109316 | csh@kino-biotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Sun Yat-Sen University Cancer Center | Principal Investigator |
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| Disease control rate (DCR) assessed as per RECIST 1.1 |
| 33 months |
| Progression-free survival (PFS) assessed as per RECIST 1.1 | 33 months |
| Overall survival (OS) assessed as per RECIST 1.1 | 33 months |
| Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) | 33 months |
| Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC) | 33 months |
| Pharmacokinetic parameters including half-life (t1/2) | 33 months |
| Pharmacokinetic parameters including time to maximum concentration (Tmax) | 33 months |
| Pharmacokinetic parameters including Apparent clearance (CL/F) | 33 months |