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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMT-151 Dose Escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-151 | Drug | Administered intravenously |
|
| 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 | Up to 24 months |
| Maximum Tolerated Dose (MTD) | The MTD will be determined using DLTs | Up to 24 months |
| Incidence of Adverse Events | Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 | Proportion of patients achieving Complete Response (CR) or Partial Response (PR) | Up to 24 months |
| Disease Control Rate (DCR) according to the RECIST v1.1 |
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Key Inclusion Criteria:
Patients must be willing and able to sign the Informed Consent Form, and to adhere to the study visit schedule and other protocol requirements.
Age ≥18 years (at the time consent is obtained).
Patients with the following histologically confirmed, advanced cancer diagnoses:
Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
Patients must have at least one measurable or non-measurable lesion as per RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate function of bone marrow, liver, kidneys, heart.
Both male and female patients must agree to use effective contraceptive methods.
Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Zhu | Contact | 13917933915 | juanjuan.zhu@multitudetherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarwan Bishnoi | Cancer Research SA | Principal Investigator |
| Richardson Gary | Cabrini Malvern Hospital | Principal Investigator |
| Steven Kao |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris O'Brien Lifehouse | Recruiting | Sydney | New South Wales | Australia |
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Proportion of patients achieving CR, PR or Stable Disease (SD) |
| Up to 24 months |
| Progression-free Survival (PFS) | Time from date of start of treatment to date of the first progression or death, whichever occurs first. | Up to 24 months |
| Time to Treatment Response (TTR) | Time from date of start of treatment to date of the first assessment of response (PR or CR) | Up to 24 months |
| Duration of Response (DoR) | Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first | Up to 24 months |
| Overall Survival (OS) | Time from date of start of treatment to date of death | Up to 24 months |
| Concentration of anti-drug antibodies (ADA) | Immunogenicity profile characterized by concentration of ADAs | Up to 24 months |
| Maximum observed concentration (C[max]) | Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151 | Up to 24 months |
| Area under the curve (AUC) | Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151 | Up to 24 months |
| Terminal half-life (t[1/2]) | Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-151 | Up to 24 months |
| Time to maximum concentration (Tmax) | Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151 | Up to 24 months |
| Chris O'Brien Lifehouse |
| Principal Investigator |
| Catherine Shannon | Mater Cancer Care Centre | Principal Investigator |
| Jermaine Coward | Integrated Haematology and Oncology Network | Principal Investigator |
| Mihitha Ariyapperuma | One Clinical Research (OCR) | Principal Investigator |
| ICON Cancer Centre | Recruiting | Brisbane | Queensland | Australia |
|
| Mater Cancer Care Centre | Recruiting | South Brisbane | Queensland | Australia |
|
| Cancer Research SA | Recruiting | Adelaide | South Australia | Australia |
|
| Cabrini Malvern Hospital | Recruiting | Malvern | Victoria | Australia |
|
| One Clinical Research (OCR) | Recruiting | Perth | Western Australia | Australia |
|
| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
|
| Shanghai Tumor Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D016889 | Endometrial Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D000230 | Adenocarcinoma |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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