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Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
Solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation of VIP236 (Q3W) | Experimental | Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle |
|
| Dose Escalation of VIP236 (Q2W) | Experimental | Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 and D15 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIP236 (Q3W) | Drug | VIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT (Dose limit toxicity) of VIP236 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days | |
| Number of participants with adverse events as a measure safety and tolerability | Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1 | Up to 24 onths | |
| Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review. |
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Inclusion Criteria:
Biliary tract cancers Breast cancer Cervical cancer Endometrial carcinoma Gastric cancer/gastroesophageal junction adenocarcinoma Nonsmall cell lung cancer Ovarian cancer/fallopian tube cancer/primary peritoneal cancer Pancreatic adenocarcinoma Small cell lung cancer Urothelial cancer
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincerx Study Director | Vincerx Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | United States | ||
| NEXT Austin |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D001943 | Breast Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D064726 | Triple Negative Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D013274 | Stomach Neoplasms |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D009362 | Neoplasm Metastasis |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| VIP236 (Q2W) | Drug | VIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle. |
|
| Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months) |
| Progression-free survival per RECIST v1.1, defined as the time from enrollment to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review | Up to 24 months |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
| Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
| Austin |
| Texas |
| 78758 |
| United States |
| NEXT Oncology San Antonio | San Antonio | Texas | 78229 | United States |
| Macquarie University | Macquarie Park | New South Wales | 2109 | Australia |
| ICON Brisbane | Brisbane | Queensland | 4101 | Australia |
| ICON Adelaide | Adelaide | Southern Australia | 5037 | Australia |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |