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TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose-escalation Phase Part B: Dose-expansion Phase | Experimental | A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK202 | Drug | Administered intravenously, once every 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies. | Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0. | Approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuntong Duan | Contact | 8618005141727 | stduan@allinkbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D&H Cancer Research Center Llc | Recruiting | Margate | Florida | 33063 | United States |
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PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf) |
| Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: Maximum serum Concentration (Cmax) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: trough Concentration(Ctrough) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: Clearance(CL) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: apparent Distribution Volume(Vd) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss) | Approximately 36 months |
| To evaluate the pharmacokinetics (PK) of ALK202 | PK parameters after single and multiple doses: terminal half-life (t1/2) | Approximately 36 months |
| To evaluate the immunogenicity of ALK202 | The generation of anti-drug antibodies (ADAs) | Approximately 36 months |
| To evaluate the preliminary antitumor activity of ALK202 | Objective Response Rate (ORR) | Approximately 36 months |
| To evaluate the preliminary antitumor activity of ALK202 | Duration of Response (DOR) | Approximately 36 months |
| To evaluate the preliminary antitumor activity of ALK202 | Disease Control Rate (DCR) | Approximately 36 months |
| To evaluate the preliminary antitumor activity of ALK202 | Progression-Free Survival (PFS) | Approximately 36 months |
| To evaluate the preliminary antitumor activity of ALK202 | Overall Survival (OS) | Approximately 36 months |
| To evaluate the biomarkers | To explore the correlation between biomarkers (EGFR/c-MET) and the efficacy and other clinical outcomes/parameters of ALK202 | Approximately 36 months |
| Next Oncology | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Scientia Clinical Research Ltd | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Macquarie University | Recruiting | Sydney | New South Wales | 2109 | Australia |
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