Cancer Clinical Trial
Official title:
Phase 1 First in Human Study of Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
Verified date | June 2023 |
Source | Jounce Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult subjects with advanced refractory solid tumor malignancies, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Status | Completed |
Enrollment | 18 |
Est. completion date | February 28, 2023 |
Est. primary completion date | July 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures; 2. Histologically or cytologically confirmed extracranial solid tumor malignancy that is recurrent, metastatic, or persistent after at least 1 line of standard therapy and with no further standard treatment options that are likely to provide meaningful clinical benefit; 3. Evaluable or measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator; while target lesions are not required, target lesions should be measured if present; 4. = 18 years of age; 5. ECOG performance status 0 or 1; 6. Predicted life expectancy of = 3 months; 7. Have laboratory values (obtained = 28 days prior to first infusion day) in accordance with the study protocol; 8. For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned Cycle 1 Day 1 (C1D1) and a negative urine pregnancy test on C1D1; 9. WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration; 10. Subjects with medical history of the following must be discussed with the Medical Monitor: 1. Prior biliary tract disorders (as based on hepatobiliary system organ class high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders). 2. Portal hypertension and/or hepatic vascular disorders. Exclusion Criteria: 1. Concurrent anticancer treatment, either FDA-approved, palliative, or investigational for the cancer being evaluated in this study or for other cancers (with protocol-specified exceptions); 2. Prior receipt of a PD-1 or PD-L1 inhibitor mAb, including JTX-4014; 3. The therapies listed below within the specified timeframe or ongoing toxicity attributed to prior therapy that was > Grade 1 according to the NCI CTCAE, with protocol-specified exceptions: 1. Major surgery < 4 weeks prior to planned C1D1; 2. Biologic therapy, including non-PD-1/PD-L1 inhibitor immunotherapy, < 28 days prior to planned C1D1; 3. Chemotherapy < 21 days prior to planned C1D1, or < 42 days for mitomycin or nitrosoureas; 4. Targeted small molecule therapy < 14 days prior to planned C1D1; 5. Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started < 14 days prior to planned C1D1, with protocol-specified exceptions; 6. Radiation therapy < 21 days prior to planned C1D1, with protocol-specified exceptions; 7. Any prior organ transplantation, including allogeneic or autologous stem cell transplantation; 4. History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events on prior non PD 1/PD L1 inhibitor immunotherapy; 5. Diagnosis of immunodeficiency, either primary or acquired, or treatment with immunosuppressive levels of systemic corticosteroids or any other form of immunosuppressive therapy within 7 days prior to planned C1D1, with protocol-specified exceptions; 6. Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients; 7. Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation, with protocol-specified exceptions; 8. Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis A, B, C, or human immunodeficiency virus; 9. Receipt of live vaccines within 30 days of planned C1D1; 10. Women who are pregnant or breastfeeding or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study; 11. History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis); 12. Symptomatic ascites or pleural effusion; 13. History of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or abdominal carcinomatosis; 14. Symptomatic cardiac or cerebrovascular disease that is unresponsive to surgical or medical management; 15. Medical or social condition that, in the opinion of the Investigator, might place the subject at increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation. |
Country | Name | City | State |
---|---|---|---|
United States | Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | START Midwest - Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan |
United States | South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas |
United States | Florida Cancer Specialists - Sarasota Cattlemen | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Jounce Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % subjects with adverse events (AEs) | Approximately 12 months | ||
Primary | % subjects with serious adverse events (SAEs) | Approximately 12 months | ||
Primary | % subjects with dose-limiting toxicities (DLTs) | Approximately 12 months | ||
Primary | % subjects with changes from baseline in pro-inflammatory cytokines | Approximately 12 months | ||
Primary | % subjects with clinically significant change from baseline in clinical laboratory tests | Approximately 12 months | ||
Primary | Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JTX-4014 | Approximately 12 months | ||
Secondary | Maximum measured concentration in serum (Cmax) | Approximately 12 months | ||
Secondary | Time from dosing to Cmax (Tmax) | Approximately 12 months | ||
Secondary | Area under the serum concentration-time curve (AUC) | Approximately 12 months | ||
Secondary | Last measurable concentration (Clast) | Approximately 12 months | ||
Secondary | Time to last measurable concentration (Tlast) | Approximately 12 months | ||
Secondary | Terminal half-life (t1/2) | Approximately 12 months | ||
Secondary | Accumulation ratio of JTX-4014 | Approximately 12 months | ||
Secondary | Evaluate anti-drug antibodies (ADA) against JTX-4014 | Approximately 12 months |
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