Drugs / interleukin-12
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interleukin-12

Protein / enzyme biologic

Developed for
HIV infectious disease · breast cancer · lymphoma · melanoma · cancer · cancer of unknown primary site · cervical cancer · chronic lymphocytic leukemia/small lymphocytic lymphoma
+32 more · cryptosporidiosis · cutaneous melanoma · diffuse large B-cell lymphoma · endometrial carcinoma · gastric cancer · gestational trophoblastic neoplasm · head and neck cancer · Hodgkins lymphoma · Kaposi's sarcoma · kidney cancer · large-cell immunoblastic lymphoma · leukemia · male breast carcinoma · malignant epithelial tumor of ovary · MALT lymphoma · mantle cell lymphoma · mycobacterial infectious disease · Mycobacterium avium complex disease · mycosis fungoides and variants · myelodysplastic syndrome · myeloproliferative neoplasm · neuroblastoma · nodal marginal zone B-cell lymphoma · non-small cell lung carcinoma · ocular melanoma · ovarian cancer · plasma cell myeloma · plasma cell neoplasm · small cell lung carcinoma · splenic marginal zone lymphoma · testicular germ cell tumor · Waldenstrom macroglobulinemia
Investigated by
National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · Beth Israel Deaconess Medical Center · Eastern Cooperative Oncology Group · Alliance for Clinical Trials in Oncology · Brigham and Women's Hospital
+8 more · Dana-Farber Cancer Institute · Genetics Institute · Harvard Medical School (HMS and HSDM) · Indiana University · Mayo Clinic · NYU Langone Health · United States Department of Defense · University of Southern California

Trials 24

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT02431767 Aug 2015 → Jun 2017 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00028535 Nov 2001 → Feb 2009 endometrial carcinoma, gastric cancer, male breast carcinoma, malignant epithelial tumor of ovary +2 National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00004260 Oct 1999 → Jun 2003 lymphoma Mayo Clinic Completed No outcome recorded
Phase 1 NCT00001911 Jul 1999 → Jul 2003 mycobacterial infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00003439 Aug 1998 → May 2001 cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00003330 Jul 1998 → Apr 2002 cancer of unknown primary site National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00003412 Jun 1998 → ? breast cancer Beth Israel Deaconess Medical Center Unknown No outcome recorded
Phase 1 NCT00001763 Apr 1998 → Mar 2000 AIDS, Mycobacterium avium complex disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00003107 Oct 1997 → ? breast cancer, gestational trophoblastic neoplasm, kidney cancer, leukemia +6 Indiana University Completed No outcome recorded
Phase 1 NCT00000857 ? → Jun 2001 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT00622401 Dec 2009 → Oct 2014 breast cancer Beth Israel Deaconess Medical Center Terminated No outcome recorded
Phase 1/2 NCT00019188 Jan 1997 → Mar 2007 Kaposi's sarcoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 28 trials
Phase 2 NCT01307618 Feb 2011 → Jan 2015 melanoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT00026143 Oct 2001 → Jul 2004 melanoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00004893 Dec 1999 → Feb 2002 breast cancer Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 2 NCT00003575 Jan 1999 → Apr 2002 lymphoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00003339 Nov 1998 → Nov 1999 cutaneous melanoma, ocular melanoma University of Southern California Completed No outcome recorded
Phase 2 NCT00003210 Feb 1998 → Nov 2003 Hodgkins lymphoma, MALT lymphoma, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +6 National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00003149 Dec 1997 → Sep 2006 plasma cell myeloma Eastern Cooperative Oncology Group Completed No outcome recorded
Phase 2 NCT00003017 Jul 1997 → Aug 2005 cervical cancer Eastern Cooperative Oncology Group Completed No outcome recorded
Phase not applicable3 trials
— NCT00899821 Jun 2000 → Dec 2004 head and neck cancer NYU Langone Health Completed No outcome recorded
— NCT00001128 ? → Jun 2005 HIV infectious disease, cryptosporidiosis National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
— NCT00000896 ? → Oct 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Comparator or background therapy1 trial
Phase 1/2 NCT04388033 Background Dec 2020 → Dec 2022 glioblastoma Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 107

DateIssuerRelease
2026-05-18 Kolon Life Science Results [보도자료] 코오롱생명과학, KLS-3021 美 ASGCT 구두 발표…삼중음성유방암 항암효과 및 장기 면역기억 형성 확인 kolonls.co.kr ↗
종양이 일정 크기에 도달한 이후 KLS-3021을 종양 내 단회 투여한 결과, 용량 의존적인 종양 성장 억제 효과가 확인됐으며, 고용량군에서는 완전관해(CR)도 관찰됐다.
2026-04-27 Kolon Life Science Results [보도자료] 코오롱생명과학, KLS-3021 피부암 연구 국제학술지 게재…전이암 억제 및 항암 면역환경 개선 가능성 제시 kolonls.co.kr ↗
연구 결과, KLS-3021은 cSCC 세포주에서 정상세포 대비 높은 암세포 선택적 세포독성 및 바이러스 증식 능력을 나타냈다.
2026-04-08 Trogenix ltd Results Trogenix announces publication of breakthrough pre-clinical data in Nature demonstrating complete tumour eradication and durable protection in aggressive brain cancer model trogenix.com ↗
2026-01-30 PDS Biotechnology Corp. Results PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI pdsbiotech.com ↗
Results showed median progression-free survival (“PFS”) of 9.6 months (range: 4.3–32.2 months) for the combination therapy in mCRPC patients.
2025-12-07 Akeso Regulatory 康方5个新药所有适应症全部谈判成功,纳入国家医保:2个首创双抗新增一线适应症及3个新药首次进医保 akesobio.com ↗
2025-11-07 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Presents Data Expanding Its PREDATOR® Platform at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting werewolftx.com ↗
The new preclinical data presented at SITC expand on this foundation by demonstrating two novel therapeutic strategies: a sequential regimen designed to safely harness the complementary immune mechanisms of IL-12 and IL-2, and the development of masked, conditional T cell engagers (INDUCER molecules) designed to mitigate systemic toxicities.
2025-10-17 Kolon Life Science Results [보도자료] 코오롱생명과학, ‘2025 유럽종양학회’ 포스터 발표…KLS-3021 전립선암 대상 전임상 결과 첫 공개 kolonls.co.kr ↗
이번 전립선암 동소이식 종양모델을 사용한 항암 효능 평가에서 KLS-3021의 단 1회 투여로 종양 크기가 유의하게 감소한 것으로 나타났으며, 대조군 항암제인 도세탁셀(docetaxel) 대비해서도 우수한 항암 효과가 관찰됐다.
2025-09-22 Imunon Results IMUNON Presents IMNN-001 Phase 2 Translational Data in Advanced Ovarian Cancer Demonstrating 13-Month OS Extension via Tumor Micro-Environment Shift imunon.com ↗
Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells.
2025-05-20 Kolon Life Science Results [보도자료] 코오롱생명과학, 美 유전자세포치료학회(ASGCT)서 ‘KLS-3021’ 피부 편평세포암 전임상 결과 포스터 발표 kolonls.co.kr ↗
발표에 따르면 KLS-3021은 사람 피부 편평세포암 세포주에서 정상 사람 표피 각질 세포 대비 높은 선택적 세포 독성을 나타냄과 동시에 종양세포 내에서 활발하게 복제해 암세포를 효과적으로 사멸시키는 것으로 확인됐다.
2025-04-29 Microbiotica Ltd Results Microbiotica reveals novel mechanisms showing how the microbiome can improve immunotherapy response based on MB097, a clinical-stage drug candidate being evaluated in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma microbiotica.com ↗
These assays have demonstrated that three of the MB097 strains induce dendritic cells to produce high levels of IL-12, which in turn stimulates Cytotoxic T Lymphocytes and NK cells with potent tumour cell killing activity.
2025-04-18 Akeso Regulatory 康方生物爱达罗®(依若奇,IL-12/IL-23)治疗中重度斑块状银屑病适应症获批上市 akesobio.com ↗
2025年4月18日,康方生物(9926.HK)欣然宣布,公司独立自主研发的爱达罗®(依若奇单抗,IL-12/IL-23“双靶向”单克隆抗体)获得国家药品监督管理局(NMPA)批准上市,适用于中重度斑块状银屑病成人患者的治疗.
2025-02-19 Imunon Results IMUNON Announces Translational Data from Phase 1/2 OVATION 2 Study of IMNN-001 in Advanced Ovarian Cancer imunon.com ↗
Results demonstrated a 20% increase in IL-12 levels in women treated with IMNN-001 (100 mg/m 2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) compared to IL-12 levels in women treated with IMNN-001 (79 mg/m 2 ).

All press releases naming this drug 126 releases

DateIssuerRelease
Show all 126 releases opens the full record — a long page

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

FieldValueCited text
Known as Interleukin-12 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00001763 ↗
24

NCT04388033 ↗

NCT00003210 ↗

NCT00003330 ↗

NCT00003339 ↗

NCT00005779 ↗

NCT02431767 ↗

NCT00004893 ↗

NCT00000896 ↗

NCT00003149 ↗

NCT00003107 ↗

Show 14 more sources

Known as IL-12 “The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat...” NCT00001128 ↗
10

“Interleukin-12 (IL-12) facilitates cytolytic T-cell responses, enhances the lytic activity of natural killer (NK) cells, and induces the secretion of interferon gamma...” PMID 11756154 ↗ Jan 2002

“This study will test the safety and effectiveness of a drug called interleukin-12 (IL-12) in fighting severe infectious (other than tuberculosis) caused by a group of bacteria...” NCT00001911 ↗

“Interleukin-12 (IL-12) is a potent immunopotentiator of T-cell function, and has been shown in phase I clinical trials to be tolerable.” PMID 14984966 ↗ Mar 2004

“The Eastern Cooperative Oncology Group (ECOG) conducted a phase II trial of interleukin-12 (IL-12) for plateau phase multiple myeloma.” PMID 19243818 ↗ Feb 2009

“ARM II: Patients receive vaccination as in arm I with an admixture of recombinant interleukin-12 (IL-12) on days 1, 22, and 50.” NCT01307618 ↗

“IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system.” NCT00000896 ↗

“Patients receive interleukin-12 (IL-12) subcutaneously twice a week (at least 3 days apart) for 6 months.” NCT00019188 ↗

“Interleukin-12 (IL-12) is a cytokine with effects on immune function and hematopoiesis.” PMID 11211153 ↗ Jan 2001

“Interleukin-12 (IL-12) is a central, regulatory cytokine in cell-mediated immunity.” NCT00001763 ↗

“Interleukin-12 (IL-12) DNA adjuvant” NCT02431767 ↗

Known as NSC # 672423 “A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion” NCT00003439 ↗
Known as pIL-12 “plasmid IL-12 (pIL-12)” PMID 32437332 ↗ Jul 2020
Known as Recombinant Human Interleukin-12 “A Phase I, Double-Blind, Randomized, Placebo-Controlled Trial of Recombinant Human Interleukin-12 (rhIL-12) in HIV-Infected Subjects With Less Than 50 CD4+ T Cells and Subjects...” NCT00000857 ↗
2

“recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion” NCT00003439 ↗

“a new schedule of i.v. recombinant human interleukin 12 (rhIL-12)” PMID 10815886 ↗ May 2000

Known as recombinant interleukin-12 “Biological: recombinant interleukin-12” NCT00003439 ↗
Known as rhIL-12 “A Phase I, Double-Blind, Randomized, Placebo-Controlled Trial of Recombinant Human Interleukin-12 (rhIL-12) in HIV-Infected Subjects With Less Than 50 CD4+ T Cells and Subjects...” NCT00000857 ↗
3

“recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion” NCT00003439 ↗

“a new schedule of i.v. recombinant human interleukin 12 (rhIL-12)” PMID 10815886 ↗ May 2000

“interleukin-12 (rhIL-12)” NCT00003412 ↗

Action Activate “Interleukin-12 may stimulate the white blood cells to kill tumor cells.” NCT00622401 ↗
Modality Protein / enzyme biologic “Recombinant Human Interleukin-12 (rhIL-12)” NCT00000857 ↗
Route Subcutaneous “by subcutaneous injection” NCT00000857 ↗