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This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNF2105 | Experimental | The dosage was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4) | Drug | The dosage of LNF2105 was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors | Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v6.0 after single or multiple doses of LNF2105. | Approximately 24months |
| To confirm Dose Limiting Toxicities (DLT) and determine MTD and RP2D for LNF2105 | Occurrence of Dose Limiting Toxicities as defined in the protocol | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of LNF2105 (ADC), Total Antibody and Free Payload (Cmax) | Maximum observed plasma concentration ofLNF2105 (ADC), Total Antibody and Free Payload after single and multiple doses | Approximately 24 months |
| Time to reach Cmax of LNF2105 (ADC), Total Antibody and Free Payload (Tmax) |
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Inclusion Criteria:
7) ECOG score 0-1. 8) Expected survival ≥ 3 months. 9) Willing to participate and sign informed consent form, and willing to follow the trial treatment protocol and visitation plan.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaohong Yin | Contact | 86-15265901803 | yinshaohong@lunan.com.cn |
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| ID | Term |
|---|---|
| C019722 | arginine decarboxylase |
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The amount of time to reach Cmax after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload |
| 24 month |
| Total Area Under the plasma concentration-time curve of LNF2105 (ADC), Total Antibody and Free Payload (AUC) | Area under the plasma concentration versus time curve after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload | 24 month |
| Minimum Plasma Concentration (Cmin) of LNF2105 (ADC), Total Antibody and Free Payload | Minimum Plasma Concentration (Cmin) of of LNF2105 (ADC), Total Antibody and Free Payload after multiple doses | 24 month |
| To evaluate the preliminary antitumor activity of LNF2105: Overall response rate (ORR) | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Approximately 24months |
| To evaluate the preliminary antitumor activity of LNF2105: Progression free survival (PFS) | PFS per investigator assessed RECIST 1.1 | Approximately 24months |
| To evaluate the preliminary antitumor activity of LNF2105: Duration of response (DOR) | Anti-tumor preliminary efficacy will be evaluated of LNF2105 in accordance with RECIST v1.1 | Approximately 24months |
| To evaluate the preliminary antitumor activity of LNF2105: Disease control rate (DCR) | DCR per investigator assessed RECIST 1.1 | Approximately 24months |
| To evaluate the preliminary antitumor activity of LNF2105: Time to response (TTR) | TTR per investigator assessed RECIST 1.1 | Approximately 24months |
| To evaluate the preliminary antitumor activity of LNF2105: Overall survival (OS) | OS per investigator assessed RECIST 1.1 | Approximately 24months |
| To evaluate the immunogenicity of LNF2105 | To evaluate the levels of anti-drug antibody (ADA) generated by study participants. Confirmatory testing will be performed on ADA-positive samples; confirmed positive samples will undergo subsequent titer determination as appropriate. | Approximately 24months |