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| ID | Type | Description | Link |
|---|---|---|---|
| 168703 | Other Identifier | NextCure, Inc. |
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| Name | Class |
|---|---|
| LigaChem Biosciences, Inc. | INDUSTRY |
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This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Dose Escalation and Backfills | Experimental | Aim: Doses of LNCB74 will be escalated to determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D). One or more dose levels will be backfilled for safety and additional biomarker data. |
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| Part 2 - Dose Expansion / Optimization | Experimental | Aim: The objectives of the Part 2 Dose Expansion/Optimization are: i) to evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics of LNCB74 in a more homogenous population and ii) characterize the minimally safe and effective dose in a particular tumor type and determine recommended Phase 2 dose(s) (RP2D). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNCB74 | Drug | LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of LNCB74 | Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities per NCI CTCAE v5.0 | 24 months |
| Define a recommended Phase 2 dose (RP2D) of LNCB74 | Maximum tolerated dose (MTD), maximum administered dose (MAD) and/or recommended Phase 2 dose (RP2D) of LNCB74 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the immunogenicity of LNCB74 | Incidence of anti-drug antibodies to LNCB74 | 24 months |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Family Cancer Institute | Recruiting | Newport Beach | California | 92663 | United States |
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| 24 months |
| Duration of Response (DOR) | Duration of response per RECIST v1.1 | 24 months |
| Disease Control Rate (DCR) | Disease control rate per RECIST v1.1 | 24 months |
| Progression Free Survival Rate (PFSR) | Progression Free Survival Rate per RECIST v1.1 | 6 months |
| Correlate B7-H4 Expression with Objective Response Rate (ORR) | To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Objective Response Rate (ORR) | 24 months |
| Correlate B7-H4 Expression with Duration of Response (DOR) | To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Duration of Response (DOR) | 24 months |
| Correlate B7-H4 Expression with Disease Control Rate (DCR) | To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Disease Control Rate (DCR) | 24 months |
| Correlate B7-H4 Expression with Progression Free Survival (PFS) | To determine B7-H4 expression by immunohistochemistry in a central lab and correlate B7-H4 expression with Progression Free Survival (PFS) | 24 months |
| Progression Free Survival (PFS) | Progression Free Survival per RECIST v1.1 | 24 months |
| Time to Peak Drug Concentration (Tmax) of LNCB74 | To evaluate the Time to Peak Drug Concentration (Tmax) of LNCB74 | Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9 |
| Area Under the Curve (AUC) of LNCB74 | To evaluate the Area Under the Curve (AUC) of LNCB74 | Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9 |
| Half-life (T1/2) of LNCB74 | To evaluate the Half-life (T1/2) of LNCB74 | Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9 |
| Maximum Serum Concentration (Cmax) of LNCB74 | To evaluate the Maximum Serum Concentration (Cmax) of LNCB74 | Cycle 1 Days 1, 3, 8 and 15; Cycle 3 Days 1, 3, 8 and 15; Day 1 of Cycles 2, 4, 5, 7 and 9 |
| St. Elizabeth Healthcare | Recruiting | Edgewood | Kentucky | 41017 | United States |
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| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Washington University, Siteman Cancer Center | Recruiting | St Louis | Missouri | 63108 | United States |
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| John Theurer Cancer Ctr at Hackensack Univ. Med Ctr. | Not yet recruiting | Hackensack | New Jersey | 07601 | United States |
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| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
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| Cleveland Clinic Taussig Cancer Institute | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Sidney Kimmel Comprehensive Center at Jefferson | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| NEXT Oncology | Completed | San Antonio | Texas | 78229 | United States |
| UT Health San Antonio - MD Anderson Cancer Center | Recruiting | San Antonio | Texas | 78229 | United States |
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| Intermountain/LDS Hospital Ph 1 Research Program | Recruiting | Salt Lake City | Utah | 84143 | United States |
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| Inova Schar Cancer Institute | Recruiting | Falls Church | Virginia | 22031 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D004067 | Digestive System Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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