Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors
NCT ID: NCT04294576
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
92 participants
INTERVENTIONAL
2019-12-04
2024-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1; BJ-001
Phase 1a Part 1, Part 2, and Part 4: dose escalation for BJ-001 as single agent
BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
Arm 2; BJ-001 and pembrolizumab
Phase 1a Part 3 and Part 5: dose escalation for BJ-001 in combination with Pembrolizumab
Phase 1b: expansion cohorts for the combination of BJ-001 and pembrolizumab
BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
Pembrolizumab
BJ-001 dosed via SC injection in combination with Pembrolizumab
One cycle is 6 weeks.
Interventions
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BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
Pembrolizumab
BJ-001 dosed via SC injection in combination with Pembrolizumab
One cycle is 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phase 1b patients must have locally advanced or metastatic and/or non-resectable head and neck squamous cell carcinoma, cholangiocarcinoma, stomach cancer, melanoma, pancreatic cancer, NSCLC (as high expression of αVβ3, αVβ5, or αVβ6 have been reported for these tumors)
* Measurable disease: For Phase 1a patients can have non-measurable or measurable disease. For all other parts: measurable disease defined by RECIST v1.1 is required
* For Phase 1a Part 3 and Phase 1b patients (combination treatment) must be refractory or relapsed to anti-PD-1, anti-PD-L1 or anti-CTLA4 checkpoint inhibitors for all tumor types, For Part 1 and Part 2 of Phase 1a (BJ-001 single agent treatment) both checkpoint inhibitor naïve or refractory/relapsed patients will be considered.
* Patient who have diagnosis for which treatment with pembrolizumab to be enrolled. Patients previously treated with pembrolizumab and who have progressed are eligible. to be enrolled.
* Adequate hematologic function,
* Adequate hepatic function, defined by all of the following:
* Adequate renal function defined by estimated creatinine clearance ≥ 45 mL/min (Cockcroft and Gault formula
* ECOG Performance Status (PS) of 0-2.
* No history of any hematopoietic malignancy.
* No active or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy).
Exclusion Criteria
* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives (LHRH antagonists are allowed).
* Patients previously treated with an anti PD-1/PD-L1 targeting agent who have had any prior history of immune-mediated pneumonitis, any immune-mediated toxicity of ≥ Grade 3,
* Patients with a history of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity.
* Patients with a history of pneumonitis, myocarditis, history of Stevens-Johnson syndrome or toxic epidermal necrolysis.
* Patients who have undergone a bone marrow transplantation, solid organ transplantation, or stem cell transplant.
* Patients with unresolved AEs \> Grade 1 from prior anticancer therapy.
* Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment.
* Uncontrolled primary central nervous system (CNS) tumors or CNS metastases; based on screening.
* Patients with active autoimmune disease or a documented medical history of autoimmune disease managed by replacement therapy.
18 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
BJ Bioscience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joe Zhang, PhD
Role: STUDY_DIRECTOR
BJ Bioscience
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai
New York, New York, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
NEXT Oncology
San Antonio, Texas, United States
Northwest Medical Specialities
Tacoma, Washington, United States
Countries
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References
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Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.
Caudana P, Nunez NG, De La Rochere P, Pinto A, Denizeau J, Alonso R, Niborski LL, Lantz O, Sedlik C, Piaggio E. IL2/Anti-IL2 Complex Combined with CTLA-4, But Not PD-1, Blockade Rescues Antitumor NK Cell Function by Regulatory T-cell Modulation. Cancer Immunol Res. 2019 Mar;7(3):443-457. doi: 10.1158/2326-6066.CIR-18-0697. Epub 2019 Jan 16.
Conlon KC, Lugli E, Welles HC, Rosenberg SA, Fojo AT, Morris JC, Fleisher TA, Dubois SP, Perera LP, Stewart DM, Goldman CK, Bryant BR, Decker JM, Chen J, Worthy TA, Figg WD Sr, Peer CJ, Sneller MC, Lane HC, Yovandich JL, Creekmore SP, Roederer M, Waldmann TA. Redistribution, hyperproliferation, activation of natural killer cells and CD8 T cells, and cytokine production during first-in-human clinical trial of recombinant human interleukin-15 in patients with cancer. J Clin Oncol. 2015 Jan 1;33(1):74-82. doi: 10.1200/JCO.2014.57.3329. Epub 2014 Nov 17.
Cox L, Larenas-Linnemann D, Lockey RF, Passalacqua G. Speaking the same language: The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. J Allergy Clin Immunol. 2010 Mar;125(3):569-74, 574.e1-574.e7. doi: 10.1016/j.jaci.2009.10.060. Epub 2010 Feb 7.
Desbois M, Le Vu P, Coutzac C, Marcheteau E, Beal C, Terme M, Gey A, Morisseau S, Teppaz G, Boselli L, Jacques Y, Bechard D, Tartour E, Cassard L, Chaput N. IL-15 Trans-Signaling with the Superagonist RLI Promotes Effector/Memory CD8+ T Cell Responses and Enhances Antitumor Activity of PD-1 Antagonists. J Immunol. 2016 Jul 1;197(1):168-78. doi: 10.4049/jimmunol.1600019. Epub 2016 May 23.
Hensley TR, Easter AB, Gerdts SE, De Rosa SC, Heit A, McElrath MJ, Andersen-Nissen E. Enumeration of major peripheral blood leukocyte populations for multicenter clinical trials using a whole blood phenotyping assay. J Vis Exp. 2012 Sep 16;(67):e4302. doi: 10.3791/4302.
Knudson KM, Hicks KC, Alter S, Schlom J, Gameiro SR. Mechanisms involved in IL-15 superagonist enhancement of anti-PD-L1 therapy. J Immunother Cancer. 2019 Mar 21;7(1):82. doi: 10.1186/s40425-019-0551-y.
Erratum: Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2):188-195. Blood. 2016 Sep 15;128(11):1533. doi: 10.1182/blood-2016-07-730689.
Lenz HJ. Management and preparedness for infusion and hypersensitivity reactions. Oncologist. 2007 May;12(5):601-9. doi: 10.1634/theoncologist.12-5-601.
Mier JW, Brandon EP, Libby P, Janicka MW, Aronson FR. Activated endothelial cells resist lymphokine-activated killer cell-mediated injury. Possible role of induced cytokines in limiting capillary leak during IL-2 therapy. J Immunol. 1989 Oct 1;143(7):2407-14.
Raedler LA. Opdivo (Nivolumab): Second PD-1 Inhibitor Receives FDA Approval for Unresectable or Metastatic Melanoma. Am Health Drug Benefits. 2015 Mar;8(Spec Feature):180-3. No abstract available.
Rhode PR, Egan JO, Xu W, Hong H, Webb GM, Chen X, Liu B, Zhu X, Wen J, You L, Kong L, Edwards AC, Han K, Shi S, Alter S, Sacha JB, Jeng EK, Cai W, Wong HC. Comparison of the Superagonist Complex, ALT-803, to IL15 as Cancer Immunotherapeutics in Animal Models. Cancer Immunol Res. 2016 Jan;4(1):49-60. doi: 10.1158/2326-6066.CIR-15-0093-T. Epub 2015 Oct 28.
Rosenberg SA. IL-2: the first effective immunotherapy for human cancer. J Immunol. 2014 Jun 15;192(12):5451-8. doi: 10.4049/jimmunol.1490019.
Sim GC, Radvanyi L. The IL-2 cytokine family in cancer immunotherapy. Cytokine Growth Factor Rev. 2014 Aug;25(4):377-90. doi: 10.1016/j.cytogfr.2014.07.018. Epub 2014 Aug 1.
Salmaninejad A, Valilou SF, Shabgah AG, Aslani S, Alimardani M, Pasdar A, Sahebkar A. PD-1/PD-L1 pathway: Basic biology and role in cancer immunotherapy. J Cell Physiol. 2019 Aug;234(10):16824-16837. doi: 10.1002/jcp.28358. Epub 2019 Feb 19.
Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nat Rev Immunol. 2006 Aug;6(8):595-601. doi: 10.1038/nri1901.
West EE, Jin HT, Rasheed AU, Penaloza-Macmaster P, Ha SJ, Tan WG, Youngblood B, Freeman GJ, Smith KA, Ahmed R. PD-L1 blockade synergizes with IL-2 therapy in reinvigorating exhausted T cells. J Clin Invest. 2013 Jun;123(6):2604-15. doi: 10.1172/JCI67008. Epub 2013 May 15.
Wrangle JM, Velcheti V, Patel MR, Garrett-Mayer E, Hill EG, Ravenel JG, Miller JS, Farhad M, Anderton K, Lindsey K, Taffaro-Neskey M, Sherman C, Suriano S, Swiderska-Syn M, Sion A, Harris J, Edwards AR, Rytlewski JA, Sanders CM, Yusko EC, Robinson MD, Krieg C, Redmond WL, Egan JO, Rhode PR, Jeng EK, Rock AD, Wong HC, Rubinstein MP. ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer: a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2018 May;19(5):694-704. doi: 10.1016/S1470-2045(18)30148-7. Epub 2018 Apr 5.
Related Links
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KEYTRUDA (pembrolizumab), \[package insert\]. Merck Sharp \& Dohme Corp. Whitehouse Station, NJ.2014. Accessed at Drugs@FDA: FDA Approved Drug Products on December 28, 2018.
OPDIVO (nivolumab), \[package insert\]. Bristol-Myers Squibb Company, Princeton, NJ. 2014. Accessed at Drugs@FDA: FDA Approved Drug Products on November 15, 2018.
TECENTRIQ (atezolizumab), \[package insert\]. Genentech, Inc. San Francisco, CA. 2016. Accessed at Drugs@FDA: FDA Approved Drug Products on December 6, 2018.
YERVOY (ipilimumab), \[package insert\]. Bristol-Myers Squibb Company, Princeton, NJ. 2011. Accessed at Drugs@FDA: FDA Approved Drug Products on July 10, 2018.
Other Identifiers
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KEYNOTE-F13
Identifier Type: OTHER
Identifier Source: secondary_id
BJ-001-01-001US
Identifier Type: -
Identifier Source: org_study_id
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