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This is a first-in-human, open-label, multicenter Phase Ia/Ib study of AMT- 676, followed by an open-label, multicenter, dose-escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMT-676 Dose escalation | Experimental | Drug- AMT-676 Dosage level: AMT-676 will be administered as an intravenous (IV) infusion. Dosage form: Vial Route of administration: Intravenous Infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-676 | Drug | Participants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data | 30 days after the last dose of IMP |
| Maximum Tolerated Dose (MTD) | The MTD will be determined using DLTs | 30 days after the last dose of IMP |
| Type, incidence and severity of Adverse Events | Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0 | 30 days after the last dose of IMP |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (C[max]) | Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-676 | 30 days after the last dose of IMP |
| Time to maximum concentration (Tmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Zhu | Contact | +86 13917933915 | juanjuan.zhu@multitudetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Biooncology Institute | Not yet recruiting | Huntersville | North Carolina | 28078 | American Samoa |
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Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-676
| 30 days after the last dose of IMP |
| Area under the curve (AUC) | Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-676 | 30 days after the last dose of IMP |
| Terminal half-life (t[1/2]) | Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-676 | 30 days after the last dose of IMP |
| Concentration of anti-drug antibodies (ADA) | Immunogenicity profile characterized by concentration of ADAs | 30 days after the last dose of IMP |
| 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) | 30 days after the last dose of IMP |
| Disease Control Rate (DCR) according to the RECIST v1.1 | Proportion of patients achieving CR, PR or Stable Disease (SD) | 30 days after the last dose of IMP |
| Progression-free Survival (PFS) | Time from date of start of treatment to date of the first progression or death, whichever occurs first | 30 days after the last dose of IMP |
| John Hopkins Sidney Kimmel Comprehensive Cancer Center | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | American Samoa |
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| South Texas Accelerated Research Therapeutics (start) San Antonio | Not yet recruiting | San Antonio | Texas | American Samoa |
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| SCIENTIA Clinical Research Ltd | Recruiting | Randwick | New South Wales | Australia |
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| Macquarie University Hospital | Recruiting | Macquarie | New South wWales | Australia |
| Gallipoli Medical Research Foundation | Recruiting | Greenslopes | Queensland | Australia |
| Cabrini Hospital | Recruiting | Melbourne | Victoria | Australia |
| Linear Research | Recruiting | Nedlands | Western Australia | Australia |
| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| Shanghai East Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Sir Run Run Shaw Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310016 | China |
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