Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-28 @ 1:09 AM
Study NCT ID:
NCT02187302
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542292', 'term': 'IT-101'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D000077210', 'term': 'Sunitinib'}, {'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'C516667', 'term': 'pazopanib'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2019-05-16', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2014-06-30', 'dispFirstSubmitQcDate': '2019-05-16', 'studyFirstSubmitQcDate': '2014-07-09', 'dispFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'at least 6 months', 'description': "To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1"}], 'secondaryOutcomes': [{'measure': 'Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)', 'timeFrame': 'at least 30 days post last dose of study drug', 'description': 'AEs will be coded using MedDRA and graded according to CTCAE (v 4.03). The number and percentage of patients with any treatment-emergent AE (TEAE) will be summarized for each treatment group. The number of patients with TEAEs assessed by the Investigator as at least possibly related to treatment will be tabulated. The number of patients with any CTCAE grade ≥ 3 treatment-emergent AE will be tabulated. Serious AEs (SAEs) will also be tabulated.\n\nFor Clinical Laboratory Parameters - Shift tables that present changes from baseline to worst on-study values relative to CTCAE grading will be produced.\n\nFor Vital Signs - By-patient data listings of vital sign measurements will be presented.\n\nFor Concomitant Medications - The use of concomitant medications will be included in by-patient data listings. A summary table of concomitant medications by WHO drug class will also be provided.'}, {'measure': 'Overall survival', 'timeFrame': 'on average 12 months after discontinuation of study treatment', 'description': 'To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.'}, {'measure': 'Objective response rate', 'timeFrame': 'at least 6 months', 'description': 'Evaluate response rates comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator'}, {'measure': 'Duration of Response', 'timeFrame': 'at least 6 months', 'description': 'Evaluate time to response comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator'}, {'measure': 'PFS', 'timeFrame': 'at least 6 months', 'description': "To assess PFS in patients with clear cell metastatic RCC treated with CRLX101+bevacizumab vs. SOC per investigator's choice, as assessed at the site level by the Investigator according to RECIST version 1.1"}, {'measure': 'PFS', 'timeFrame': 'at least 6 months', 'description': 'To assess PFS (as assessed at the site level by the Investigator and separately by blinded IRR) in clear cell RCC patients treated with CRLX101+bevacizumab compared to bevacizumab treatment alone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nanopharmaceutical,'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '28950297', 'type': 'DERIVED', 'citation': 'Voss MH, Hussain A, Vogelzang N, Lee JL, Keam B, Rha SY, Vaishampayan U, Harris WB, Richey S, Randall JM, Shaffer D, Cohn A, Crowell T, Li J, Senderowicz A, Stone E, Figlin R, Motzer RJ, Haas NB, Hutson T. A randomized phase II trial of CRLX101 in combination with bevacizumab versus standard of care in patients with advanced renal cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2754-2760. doi: 10.1093/annonc/mdx493.'}]}, 'descriptionModule': {'briefSummary': 'This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have histologically confirmed renal cell carcinoma of any pathologic subtype.\n* Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.\n* Must have received 2 or 3 prior lines of conventional molecularly targeted therapy\n* Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.\n* ECOG performance status 0 or 1.\n* Age 18 years and older.\n* Life expectancy of at least 3 months.\n* Must have normal organ and marrow function reported within 14 days prior to randomization\n* Ability to understand and willingness to sign a written informed consent document.\n* Able to comply with study visit schedule and assessments.\n\nExclusion Criteria:\n\n* Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.\n* Failure to recover to grade 1 or less all prior adverse events.\n* Any major surgery within 4 weeks of study randomization.\n* Any prior treatment with topoisomerase I therapy.\n* Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.\n* Patients receiving any other current investigational therapeutic agent.\n* Other active malignancies\n* Patients with brain metastasis treated or untreated, or other CNS disease\n* Any clinically significant cardiac disease defined as NYHA class III or IV.\n* Uncontrolled hypertension\n* Uncontrolled concurrent illness\n* History of non-healing wounds or ulcers.\n* Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding\n* Patients with known HIV or with solid organ transplant'}, 'identificationModule': {'nctId': 'NCT02187302', 'briefTitle': 'CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Pharma'}, 'officialTitle': "A Randomized, Phase 2 Study to Assess the Safety and Efficacy of CRLX101 in Combination With Bevacizumab in Patients With Metastatic Renal Cell Carcinoma (RCC) Versus Standard of Care (SOC) (Investigator's Choice)", 'orgStudyIdInfo': {'id': 'CRLX101-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRLX101 + bevacizumab', 'description': 'CRLX101 in combination with bevacizumab:\n\n* CRLX101 15 mg/m\\^2 IV on days 1 and 15 of a 28-day cycle;\n* bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.', 'interventionNames': ['Drug: CRLX101', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of care treatment include one of the following agents to which the patient can have no prior exposure: sorafenib; everolimus; pazopanib; axitinib; bevacizumab; sunitinib, or other approved drug considered by the Medical Monitor to represent an acceptable standard of care therapy', 'interventionNames': ['Drug: Standard of Care (Investigator Choice)']}], 'interventions': [{'name': 'CRLX101', 'type': 'DRUG', 'otherNames': ['NLG207'], 'armGroupLabels': ['CRLX101 + bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'armGroupLabels': ['CRLX101 + bevacizumab']}, {'name': 'Standard of Care (Investigator Choice)', 'type': 'DRUG', 'otherNames': ['sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),', 'everolimus (Afinitor), Other'], 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan St. Francis Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'June E. Nylen Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Cancer Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake Physician Group', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ann Arbor Hematoloty-Oncology', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Hematology and Oncology Associates', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'MD Anderson Cooper Cancer Institute', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, Amarillo', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology P.A.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75028', 'city': 'Flower Mound', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, Flower Mound', 'geoPoint': {'lat': 33.01457, 'lon': -97.09696}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, P.A.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Center Network of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Health Education and Research Institute', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Regional Cancer Center CCOP', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '410-769', 'city': 'Goyang-si Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center'}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severence Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'NewLink Genetics', 'role': 'STUDY_CHAIR', 'affiliation': 'NewLink Genetics Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewLink Genetics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}