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DRUG CLASS:

CD137 agonist

15d
KEYNOTE-A31: Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
P1, N=276, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Dec 2025
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
15d
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov)
P1, N=126, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting | Phase classification: P1a/1b --> P1 | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
17d
GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
P1/2, N=429, Active, not recruiting, Genmab | Trial completion date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jan 2025 --> Feb 2026
Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
22d
Combining mathematical modeling, in vitro data and clinical target expression to support bispecific antibody binding affinity selection: a case example with FAP-4-1BBL. (PubMed, Front Pharmacol)
In this work, a workflow to select binding affinities for bispecific antibodies that integrates preclinical in vitro data, mathematical modeling and simulation, and knowledge on target expression in the patient population, is provided. The early implementation of this approach can increase the probability of success with cancer immunotherapy in clinical development.
Preclinical • Journal • IO biomarker
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TNFRSF9 (TNF Receptor Superfamily Member 9) • FAP (Fibroblast activation protein, alpha)
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RG7827
23d
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P1, N=160, Terminated, Inhibrx Biosciences, Inc | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Oct 2024; Program terminated due to lack of meaningful efficacy signal.
Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
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TMB (Tumor Mutational Burden)
|
TMB-H
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Keytruda (pembrolizumab) • enristomig (INBRX-105)
1m
A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies (clinicaltrials.gov)
P1, N=36, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • azacitidine • DSP-107
1m
SAIL66, a next generation CLDN6-targeting T-cell engager, demonstrates potent antitumor efficacy through dual binding to CD3/CD137. (PubMed, J Immunother Cancer)
Our data demonstrate that SAIL66, designed to engage CLDN6, CD3, and CD137, has the potential to enhance antitumor activity and provide a potent therapeutic option for patients with ovarian and other solid tumors expressing CLDN6. Clinical trials are currently underway to evaluate the safety and efficacy of SAIL66.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CLDN6 (Claudin 6) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9)
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CLDN6 expression • CLDN6 positive
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SAIL66
1m
New P3 trial
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Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
1m
A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=125, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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KRAS mutation • EGFR mutation • BRAF mutation • KRAS wild-type • RET mutation • RAS wild-type
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Tecentriq (atezolizumab) • DSP-107
1m
Acasunlimab in combination with pembrolizumab reinvigorates anti-tumor immunity in patients with previously treated metastatic non-small cell lung cancer (NSCLC) (SITC 2024)
The study was conducted in accordance with the International Council for Harmonisation E6(R2) guidelines on good clinical practice and the principles of the Declaration of Helsinki. All patients provided written informed consent.
Combination therapy • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
|
CD8 expression • HAVCR2 expression
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PD-L1 IHC 22C3 pharmDx • GuardantOMNI
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
1m
MCLA-145-CL01: A Study of Bispecific Antibody MCLA-145 in Patients with Advanced or Metastatic Malignancies (clinicaltrials.gov)
P1, N=238, Active, not recruiting, Merus N.V. | Recruiting --> Active, not recruiting | N=118 --> 238 | Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • MCLA-145
1m
Enrollment open
|
Tevimbra (tislelizumab-jsgr)
2ms
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=245, Recruiting, Hanmi Pharmaceutical Company Limited | Trial completion date: Jul 2027 --> Jan 2028 | Trial primary completion date: Feb 2027 --> Aug 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Keytruda (pembrolizumab)
2ms
CLN-418-001: CLN-418 Study on Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=48, Completed, Cullinan Therapeutics Inc. | Recruiting --> Completed | N=108 --> 48 | Trial completion date: Jun 2024 --> Sep 2024
Trial completion • Enrollment change • Trial completion date • Metastases
|
HBM7008
2ms
Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1, N=3, Terminated, Institut de Recherches Internationales Servier | Trial completion date: Jul 2023 --> Jun 2024 | Trial primary completion date: Jul 2023 --> Jun 2024
Trial completion date • Trial primary completion date • Metastases
2ms
NCI-2018-01118: Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients with Advanced Malignancies (clinicaltrials.gov)
P1/2, N=173, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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CD8 (cluster of differentiation 8)
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Bavencio (avelumab) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
2ms
A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov)
P1/2, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
Trial completion date • Trial primary completion date
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emfizatamab (GNC-038)
2ms
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P1/2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
Trial completion date • Trial primary completion date
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emfizatamab (GNC-038)
2ms
A First-in-Human Study of cinrebafusp alfa, a HER2/4-1BB Bispecific Molecule, in Patients with HER2-Positive Advanced Solid Malignancies. (PubMed, Clin Cancer Res)
Cinrebafusp alfa demonstrates promising activity in patients with HER2-positive malignancies who have progressed on prior HER2-targeting regimens. Its acceptable safety profile suggests it could be a treatment option for patients not responding to existing HER2-directed therapies.
P1 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • TNFRSF9 (TNF Receptor Superfamily Member 9)
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HER-2 positive
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cinrebafusp alfa (PRS-343)
2ms
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors (clinicaltrials.gov)
P1, N=30, Recruiting, Genmab | Trial completion date: Oct 2027 --> Feb 2027
Trial completion date • Combination therapy
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Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • GEN1042
2ms
Photothermal therapy co-localized with CD137 agonism improves survival in an SM1 melanoma model without hepatotoxicity. (PubMed, Nanomedicine (Lond))
Next, we tested the efficacy and hepatotoxicity of PTT using αCD137-PBNPs (αCD137-PBNP-PTT) in SM1 tumor-bearing mice. The αCD137-PBNPs retained both the photothermal and agonistic properties of the PBNPs and αCD137, respectively. In vivo, SM1 tumor-bearing mice treated with αCD137-PBNP-PTT exhibited a significantly higher survival rate (50%) without hepatotoxicity, compared with control treatments. These data suggest the potential utility of co-localizing PBNP-PTT with αCD137-based agonism as a novel combination nanomedicine.
Journal
|
TNFRSF9 (TNF Receptor Superfamily Member 9)
3ms
Enrollment open
|
GPC3 (Glypican 3)
|
BOS-342
3ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • ezabenlimab (BI 754091) • BI 765179
3ms
Human/mouse CD137 agonist, JNU-0921, effectively shrinks tumors through enhancing the cytotoxicity of CD8+ T cells in cis and in trans. (PubMed, Sci Adv)
Meanwhile, JNU-0921 attenuates the inhibitory function of regulatory T cells on CTLs. Our current work shows that JNU-0921 shrinks tumors by enhancing the cytotoxicity of CTLs in cis and in trans and sheds light on strategy for developing CD137 small molecular agonists.
Preclinical • Journal
|
CD8 (cluster of differentiation 8)
3ms
Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors (clinicaltrials.gov)
P1/2, N=360, Recruiting, BioNTech SE | Trial completion date: Feb 2030 --> Jul 2027 | Trial primary completion date: Feb 2030 --> Jul 2027
Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab)
3ms
Phase classification • Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm) • englumafusp alfa (RG6076)
3ms
Enrollment closed • Enrollment change • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab)
3ms
Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1, N=3, Terminated, Institut de Recherches Internationales Servier | N=33 --> 3 | Recruiting --> Terminated; Sponsor decision
Enrollment change • Trial termination • Metastases
3ms
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P1, N=160, Active, not recruiting, Inhibrx Biosciences, Inc | Phase classification: P2 --> P1 | N=300 --> 160
Phase classification • Enrollment change • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
3ms
Enrollment change
3ms
ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=58, Completed, Adagene Inc | Recruiting --> Completed | N=91 --> 58 | Trial completion date: Dec 2024 --> May 2024
Trial completion • Enrollment change • Trial completion date • Combination therapy • Metastases
|
ADG106 • muzastotug (ADG126)
3ms
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=21, Recruiting, Adagene Inc | Trial completion date: Dec 2024 --> Oct 2025 | Trial primary completion date: Apr 2024 --> May 2025
Trial completion date • Trial primary completion date • Metastases
3ms
ADG116-1003: A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients (clinicaltrials.gov)
P1, N=72, Active, not recruiting, Adagene Inc | Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Jul 2024 --> Jan 2024
Trial completion date • Trial primary completion date • Metastases
|
Loqtorzi (toripalimab-tpzi) • ADG106
3ms
Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
P2, N=15, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • urelumab (BMS-663513)
4ms
Enrollment change • Metastases
|
cisplatin • carboplatin • etoposide IV
4ms
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors (clinicaltrials.gov)
P1/2, N=130, Active, not recruiting, Servier Bio-Innovation LLC | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2027 --> Dec 2025
Enrollment closed • Trial primary completion date
4ms
Phase classification • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
4ms
SGNBB228-001: A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov)
P1, N=275, Recruiting, Seagen Inc. | Trial completion date: Sep 2028 --> Nov 2027 | Trial primary completion date: Oct 2025 --> Nov 2026
Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene)
|
PF-08046049
4ms
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P2, N=300, Active, not recruiting, Inhibrx Biosciences, Inc | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
4ms
GNC-035-103: A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
P1, N=29, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
nebratamig (GNC-035)
4ms
A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=147, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Jun 2024 --> Oct 2024
Trial completion date • Trial primary completion date • Metastases
|
GNC-039
4ms
Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=168, Recruiting, I-Mab Biopharma US Limited | N=102 --> 168 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
|
Opdivo (nivolumab) • givastomig (TJ-CD4B)