Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part â…¡ for expansion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Dose escalation | Experimental | Five dose levels in the Phase I part of the study |
|
| Phase II: Dose Expansion | Other | Patients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-116 | Drug | AMT-116 is an antibody Drug Conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116 | The MTD(Maximum Tolerated Dose) and RP2D(Recommended Phase 2 Dose) will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data | approximately 12 months |
| Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs) | Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0 | approximately 12 months |
| Phase II: Objective Response Rate(ORR) | To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] according to the RECIST v1.1 | approximately 18 months |
| Phase II: Type, incidence and severity of Adverse Events | Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0 | approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Proportion of patients achieving Complete Response (CR) or Partial Response (PR) | approximately 12 months |
| Phase I Disease Control Rate (DCR) according to the RECIST v1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yixuan Wang | Contact | +86-021-33560023 | yixuan.wang@multitudetherapeutics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China | ||
| Dongguan People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proportion of patients achieving CR, PR or Stable Disease (SD) |
| approximately 12 months |
| Phase I: Progression-free Survival (PFS) | Time from date of start of treatment to date of the first progression or death, whichever occurs first | approximately 12 months |
| Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue | To assess levels of target expression and Tumor Infiltrating Lymphocyte in tumor tissue | approximately 12 months |
| Phase I: Concentration of anti-drug antibodies (ADA) | Immunogenicity profile characterized by concentration of ADAs | approximately 12 months |
| Phase I: Maximum observed concentration (C[max]) | Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-116 | approximately 12 months |
| Phase I: Area under the curve (AUC) | Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116 | approximately 12 months |
| Phase I: Terminal half-life (t[1/2]) | Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-116 | approximately 12 months |
| Phase I: Time to maximum concentration (Tmax) | Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116 | approximately 12 months |
| Phase II: Disease Control Rate (DCR) according to the RECIST v1.1 | Proportion of patients achieving CR, PR or Stable Disease (SD) | approximately 18 months |
| Phase II: Progression-free Survival (PFS) according to RECIST v1.1 | Time from date of start of treatment to date of the first progression or death, whichever occurs first. | approximately 18 months |
| Phase II: Duration of response (DOR) | DOR is defined as the time from the date of first documented CR or PR to PD or death due to any cause, whichever occurs first. | approximately 18 months |
| Phase II: Time to response(TTR) | The time from the start date of treatment to the date of the first response assessment (PR or CR) | approximately 18 months |
| Phase II: Levels of target expression in tumor tissue | To assess levels of target expression in tumor tissue and correlation of those levels with responses and toxicity. | approximately 18 months |
| Phase II: Percentage of patients with ADA formation to AMT-116. | To obtain Percentage of patients with ADA formation to AMT-116 | approximately 18 months |
| Phase II: Maximum observed concentration (C[max]) | To characterize the PK profile of AMT-116 by analyzing maximum observed concentration (C[max]) of the ADC, total antibody, and free payload. | approximately 18 months |
| Phase II: Area under the curve (AUC) | To characterize the PK profile of AMT-116 by analyzing area under the curve (AUC) of the ADC, total antibody, and free payload. | approximately 18 months |
| Phase II: Terminal half-life (t[1/2]) | To characterize the PK profile of AMT-116 by analyzing the pharmacokinetic parameter Terminal half-life (t½ )of the ADC, total antibody, and free payload. | approximately 18 months |
| Phase II: Time to maximum concentration (Tmax) | To characterize the PK profile of AMT-116 by analyzing the pharmacokinetic parameter time to maximum concentration (Tmax) of the ADC, total antibody, and free payload. | approximately 18 months |
| Not yet recruiting |
| Dongguan |
| Guangdong |
| China |
| Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College) | Recruiting | Guangzhou | Guangdong | China |
| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
| Zhejiang cancer hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |