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Sponsor's Decision
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To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX-072 in combination with anti-cancer therapy-front line | Experimental | histologically or cytologically confirmed solid tumor who have received no prior treatment |
|
| CX-072 in combination with ipilimumab | Experimental | histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor |
|
| CX-072 in combination with anti-cancer therapy-Progressed | Experimental | histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy |
|
| CX-072 in combination with anti-cancer therapy-Neoadjuvant | Experimental | neo-adjuvant study in subjects with histologically confirmed solid tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-072 | Drug | CX-072 in combination with ipilimumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate by RECIST v 1.1 | ORR by RECIST v1.1 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Experiencing Treatment Related Adverse Events | Safety and Tolerability of CX-072 in Combination Therapy | 2 years |
| The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Lu, MD | CytomX Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| The Angeles Clinic and Research Institute |
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Subjects who meet Inclusion / Exclusion criteria began the Screening Period within 30 days prior to the first dose of study treatment. Subjects for whom consent was provided underwent Screening Period assessments to determine eligibility for the study; assessments were to be performed within 30 days prior to the first dose of study treatment.
This study was composed of 2 parts (Part A and Part B) and 4 cohorts (A1, A2, A3, B1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line | Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2019 |
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| Ipilimumab | Drug | CX-072 in combination with ipilimumab |
|
ORR by irRECIST
| 2 years |
| Los Angeles |
| California |
| 90025 |
| United States |
| Beacon Cancer Care | Coeur d'Alene | Idaho | 83814 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| NYC Cancer Institute | New York | New York | 10016 | United States |
| Columbia Medical Center | New York | New York | 10032 | United States |
| Oregon Health & Science Center | Portland | Oregon | 97210 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Inova Dwight and March Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Multicare Institute for Research and Innovation | Spokane | Washington | 99204 | United States |
| Sunshine Coast University Private Hospital | Sunshine Coast | Queensland | Australia |
| Ballarat Oncology and Haematology Services | Wendouree | Victoria | Australia |
| The Netherlands Cancer Institute | Amsterdam | Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | South Korea |
| ICO Hospitalet, Hospital Duran I Reynals | Barcelona | 08908 | Spain |
| Hospital Clinic de Barcelona. Servicio Oncologia Medica | Barcelona | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| START- Madrid | Madrid | Spain |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| Cohort A2: CX-072 in Combination With Ipilimumab |
Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| FG002 | Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed | Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| FG003 | Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant | Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen:
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Due to the early study termination, a statistical analysis plan was not generated. The statistical analyses per the study protocol were not performed due to insufficient sample size and the efficacy and pharmacokinetic analyses were not performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line | Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| BG001 | Cohort A2: CX-072 in Combination With Ipilimumab | Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| BG002 | Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed | Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| BG003 | Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant | Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen:
|
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate by RECIST v 1.1 | ORR by RECIST v1.1 | All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline RECIST 1.1 assessment, or who discontinue treatment/study due to disease progression by RECIST v 1.1. | Posted | Count of Participants | Participants | 1 year |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Experiencing Treatment Related Adverse Events | Safety and Tolerability of CX-072 in Combination Therapy | All subjects who receive any amount of CX-072. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST | ORR by irRECIST | All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline irRECIST assessment, or who discontinue treatment/study due to disease progression by irRECIST. | Posted | Count of Participants | Participants | 2 years |
|
The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months.
All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line | Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen:
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Cohort A2: CX-072 in Combination With Ipilimumab | Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen:
| 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed | Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen:
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant | Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen:
| 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune-mediated Hepatitis | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Related Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Generalized Oedema | General disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Immune-mediated Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Rash Generalized | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Due to developmental strategic reasons and slow enrollment because of the COVID-19 pandemic, the study was terminated early. Three subjects were enrolled, all in Cohort A2. The last subject observation for this study was on 21 May 2020. Since the study terminated early, a statistical analysis plan was not generated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Lu | CytomX Therapeutics | (650) 515-3185 | clinicaltrials@cytomx.com |
| Dec 24, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| United States |
|
| Australia |
|
| Spain |
|
| Partial Response (PR) |
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| OG003 | Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant | Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen:
|
|
|
Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen:
|
| OG003 | Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant | Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen:
|
|
|
| Did not experience |
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| Did not experience |
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| Did not experience |
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| Did not experience |
|
| Did not experience |
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