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DRUG CLASS:

IL-2 stimulant

Related drugs:
6d
KEYNOTE-A78: A Phase 1 Study in Patients with HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P1, N=85, Active, not recruiting, Cue Biopharma | Trial completion date: May 2025 --> Jan 2026 | Trial primary completion date: Nov 2024 --> Jan 2026
Trial completion date • Trial primary completion date
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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PD-L1 expression
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Keytruda (pembrolizumab) • CUE-101
10d
Phase classification
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eciskafusp alfa (RG6279)
11d
AWT020: a novel fusion protein harnessing PD-1 blockade and selective IL-2 Cis-activation for enhanced anti-tumor immunity and diminished toxicity. (PubMed, Front Immunol)
Notably, this selective tumoral T-cell stimulation enables potent tumor-specific T-cell responses, underscoring the molecule's enhanced efficacy and safety. The AWT020 fusion protein offers a promising novel immunotherapeutic strategy by integrating PD-1 blockade and IL-2 signaling, conferring enhanced anti-tumor activity with reduced toxicity.
Journal
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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AWT020
13d
SHR-1916: A Novel PEGylated Interleukin-2 Analogue with Altered Cellular Selectivity and Improved Pharmacokinetic Profiles for Cancer Immunotherapy. (PubMed, Drug Des Devel Ther)
SHR-1916 exhibited excellent cellular selectivity, anti-tumor efficacies, and improved pharmacokinetics. It has the potential to serve as a novel immunotherapeutic agent designed to enhance IL-2's immune-stimulating activities and promote its tolerability while reducing the immunoregulatory function of Treg cells.
PK/PD data • Journal
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL2 (Interleukin 2)
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SHR-1916
13d
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
P1/2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2025 --> Feb 2026
Trial completion date
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mTOR (Mechanistic target of rapamycin kinase)
|
Jingzhuda (entinostat) • Proleukin (aldesleukin)
18d
Effect of E7777 Immunogenicity on Pharmacokinetics, Efficacy, and Safety in Adult Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, Clin Transl Sci)
Serious TE adverse events were reported by 32.1% of TE E-ADA-positive patients, 29.0% of TE I-ADA-positive patients, 100% of E-ADA-negative patients, and 73.3% of I-ADA-negative patients. These results indicate that the presence of ADAs decreased E7777 exposure over time but did not adversely impact efficacy and safety in patients with CTCL.
PK/PD data • Journal
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IL2 (Interleukin 2)
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Lymphir (denileukin diftitox-cxdl)
19d
A Phase II Study of Denileukin Diftitox in Patients with Advanced Treatment Refractory Breast Cancer. (PubMed, Vaccines (Basel))
Denileukin diftitox modulated regulatory T cells. However, the majority of patients experienced disease progression in the study.
P2 data • Journal
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CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • FOXP3 (Forkhead Box P3)
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Ontak (denileukin diftitox)
19d
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD (clinicaltrials.gov)
P2, N=25, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2024 --> Dec 2025
Trial completion date
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IL2 (Interleukin 2)
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Proleukin (aldesleukin)
23d
New P1 trial
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Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • capecitabine • pemetrexed • oxaliplatin • AWT020
24d
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus (clinicaltrials.gov)
P1, N=40, Active, not recruiting, Cugene Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Apr 2025 | Trial primary completion date: Jul 2024 --> Apr 2025
Enrollment closed • Trial completion date • Trial primary completion date
1m
Trial completion
1m
Efficacy of Interleukin-2 in Triple Negative Breast Cancer (clinicaltrials.gov)
P1/2, N=10, Not yet recruiting, Nova Scotia Health Authority | Trial completion date: Apr 2025 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Apr 2028
Trial completion date • Trial primary completion date • Tumor mutational burden
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PD-L1 (Programmed death ligand 1)
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Proleukin (aldesleukin)
1m
New P1 trial
1m
A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer (clinicaltrials.gov)
P1, N=260, Recruiting, Wuhan Union Hospital, China | Active, not recruiting --> Recruiting | N=49 --> 260 | Trial completion date: Jul 2025 --> Jul 2026
Enrollment open • Enrollment change • Trial completion date
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Avastin (bevacizumab) • foritinib (SAF-189)
1m
Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. (PubMed, Cell Rep Med)
It had a favorable safety profile when administered subcutaneously on days 1, 2, 8, and 9 of each 21-day cycle as monotherapy (0.25-15 μg/kg) or combined (1.5-12 μg/kg) with the anti-PD-1 pembrolizumab (200 mg). The most frequent treatment-emergent adverse events were pyrexia, injection site reactions, and chills. Furthermore, early clinical efficacy was observed, including in immune checkpoint blockade-resistant/refractory patients.
Journal
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CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
1m
KYANITE-1: A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs (clinicaltrials.gov)
P1/2, N=200, Recruiting, Krystal Biotech, Inc. | N=140 --> 200 | Trial completion date: Feb 2027 --> Feb 2028 | Trial primary completion date: Feb 2027 --> Feb 2028
Enrollment change • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab)
1m
Trial initiation date
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cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
1m
OPAL-1: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=240, Recruiting, Krystal Biotech, Inc. | N=140 --> 240 | Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2026 --> Jul 2027
Enrollment change • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Opdualag (nivolumab/relatlimab-rmbw)
1m
Phase 1b study of immunocytokine simlukafusp alfa (FAP-IL2v) combined with pembrolizumab for treatment of advanced and/or metastatic melanoma. (PubMed, Cancer Res Commun)
The safety profile of FAP-IL2v in combination with pembrolizumab was manageable and consistent with the known safety profile. However, further exploration of FAP-IL2v and pembrolizumab was precluded in melanoma patients with prior CPI due to the lack of clinical activity.
P1 data • Journal
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CD8 (cluster of differentiation 8)
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Keytruda (pembrolizumab) • simlukafusp alfa (RG7461)
2ms
IMMUNOSABR2: IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study (clinicaltrials.gov)
P2, N=88, Terminated, Maastricht University Medical Center | Active, not recruiting --> Terminated; This trial is not transitioning to the Clinical Trial Regulation (CTR) EU No 536/2014.
Trial termination
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IL2 (Interleukin 2)
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darleukin (L19IL2)
2ms
Transient lymphocyte count decrease correlates with oncolytic adenovirus efficacy in humans: mechanistic and biomarker findings from TUNIMO phase I trial. (PubMed, J Immunother Cancer)
TILT-123 therapy induced accumulation of effector lymphocytes in tumors. Peripheral lymphocyte count decrease is a promising biomarker for assessing oncolytic adenovirus therapy response.
P1 data • Journal • IO biomarker
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CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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igrelimogene litadenorepvec (TILT-123)
2ms
Trial initiation date
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darleukin (L19IL2)
2ms
Art of TIL immunotherapy: SITC's perspective on demystifying a complex treatment. (PubMed, J Immunother Cancer)
The general steps, most of which require hospital inpatient resources, include a surgical procedure to harvest sufficient tumor for TIL manufacturing, admission for non-myeloablative lymphodepleting chemotherapy followed by TIL, and intravenous interleukin-2 (IL-2, aldesleukin). Here, we provide the principles, practice, and required resources underlying the efficient and safe delivery of TIL immunotherapy derived from the clinical expertise of high-volume centers around the world. This article enhances published clinical practice guidelines by providing underlying clinical rationale and data-driven examples to demystify TIL immunotherapy in order to facilitate uptake and improve patient access to this promising treatment modality in clinical and research settings.
Review • Journal
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IL2 (Interleukin 2)
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Proleukin (aldesleukin)
2ms
New P2 trial
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation • ALK rearrangement
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Tyvyt (sintilimab)
2ms
Trial initiation date
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STK-009/SYNCAR-001
2ms
Durable complete response after combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus (TILT-123) in a patient with metastatic mucosal melanoma. (PubMed, Immunooncol Technol)
Immunohistochemical analysis and single-cell sequencing revealed interesting alterations in injected and noninjected tumors as well as in peripheral blood, during the treatment course, suggesting that TILT-123 facilitated TIL engraftment into the tumor, ultimately leading to a complete response. This case underscores the potential of combined immunotherapeutic approaches as a promising strategy for patients with metastatic mucosal melanoma.
Journal • Tumor-infiltrating lymphocyte
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IL2 (Interleukin 2)
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igrelimogene litadenorepvec (TILT-123)
2ms
Study of E7777 Prior to Kymriah for R/R DLBCL (clinicaltrials.gov)
P1/2, N=30, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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MYC (V-myc avian myelocytomatosis viral oncogene homolog)
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MYC expression
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Kymriah (tisagenlecleucel-T) • Lymphir (denileukin diftitox-cxdl)
2ms
AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=115, Terminated, SOTIO Biotech AG | N=200 --> 115 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Aug 2024; Due to lack of efficacy shown at the time of the interim analysis.
Enrollment change • Trial termination • Trial primary completion date
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
3ms
Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (clinicaltrials.gov)
P2, N=270, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2027 --> Jul 2028 | Trial primary completion date: Jan 2026 --> Apr 2027
Trial completion date • Trial primary completion date
3ms
Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, J Clin Oncol)
Efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL.
Journal
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IL2 (Interleukin 2)
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Ontak (denileukin diftitox) • Lymphir (denileukin diftitox-cxdl)
3ms
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov)
P1/2, N=46, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Trial termination • Metastases
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Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)
3ms
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas (clinicaltrials.gov)
P1, N=84, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Jun 2023 --> Jun 2026
Trial completion date • Trial primary completion date • Metastases
3ms
Dose Escalation and Expansion Study of HM16390 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=215, Recruiting, Hanmi Pharmaceutical Company Limited | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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HM16390
3ms
KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
P2, N=166, Terminated, SOTIO Biotech AG | Active, not recruiting --> Terminated; Due to lack of expected efficacy shown at the time of the interim analysis
Trial termination • Metastases
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
3ms
Type 2 responses determine skin rash during recombinant interleukin-2 therapy. (PubMed, J Immunotoxicol)
One of the drugs inducing CADRs is aldesleukin, a recombinant interleukin-2 (recIL-2) originally approved to treat malignant melanoma and metastatic renal cell carcinoma which frequently led to skin rashes when applied in high doses for anti-cancer therapy...Together, this hypothetic irAOP forms a basis to clarify possible cellular and molecular interactions leading to recIL-2-induced skin rash. This might be used to adapt existing or develop new test systems to help predict and prevent cutaneous side effects in future IL-2-based or similar therapies.
Review • Journal
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IL2 (Interleukin 2)
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Proleukin (aldesleukin)
3ms
KEYNOTE-B75: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (clinicaltrials.gov)
P2, N=59, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Trial termination
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
3ms
New P1 trial • Metastases
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HM16390