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DRUG CLASS:

CD137 agonist

4d
Safety, feasibility and pharmacodynamic activity of intratumoral injections of the agonist anti-CD137 (4-1BB) mAb urelumab in combination with nivolumab. (PubMed, Clin Cancer Res)
Intratumoral delivery of urelumab is feasible, safe, and induces favorable immunopharmacodynamic effects in serial biopsies and in peripheral blood. Our results support the development of tumor-targeted next-generation CD137 (4-1BB) agonists.
PK/PD data • Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8)
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Opdivo (nivolumab) • urelumab (BMS-663513)
4d
Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression (clinicaltrials.gov)
P1/2, N=200, Active, not recruiting, BicycleTx Limited | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Sep 2025 --> Aug 2026
Trial completion date • Trial primary completion date • First-in-human
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NECTIN4 (Nectin Cell Adhesion Molecule 4)
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Opdivo (nivolumab) • BT7480
7d
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov)
P1/2, N=73, Terminated, Ocellaris Pharma, Inc. | Trial completion date: Sep 2026 --> Nov 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2026 --> Nov 2025; Business Decision
Trial completion date • Trial termination • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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HER-2 negative • ALK fusion • ALK mutation • ROS1 fusion
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Bavencio (avelumab) • OC-001
7d
Enrollment change • Checkpoint inhibition
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BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
7d
Enrollment closed • Head-to-Head
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PD-L1 expression
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Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
10d
New P2 trial
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cisplatin • paclitaxel • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine
11d
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, Completed, Adagene Inc | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Nov 2025
Trial completion • Trial completion date
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Loqtorzi (toripalimab-tpzi) • ADG106
11d
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=14, Active, not recruiting, Adagene Inc | Recruiting --> Active, not recruiting | N=21 --> 14 | Trial completion date: Oct 2025 --> Aug 2026
Enrollment closed • Enrollment change • Trial completion date • First-in-human
12d
Enrollment open
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BRAF (B-raf proto-oncogene)
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Tecentriq (atezolizumab) • Fruzaqla (fruquintinib) • DSP-107
13d
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors (clinicaltrials.gov)
P1, N=42, Active, not recruiting, Genmab | Trial primary completion date: Mar 2026 --> Nov 2026
Trial primary completion date
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Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • tecaginlimab (GEN1042)
13d
Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=34, Completed, M.D. Anderson Cancer Center | Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025 | Active, not recruiting --> Completed
Trial completion • Trial completion date • Trial primary completion date
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MSI (Microsatellite instability)
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MSI-H/dMMR • RAS mutation
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Erbitux (cetuximab) • irinotecan • utomilumab (PF-05082566)
22d
A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=36, Recruiting, AP Biosciences Inc. | Not yet recruiting --> Recruiting | Initiation date: Sep 2025 --> Jan 2026
Enrollment open • Trial initiation date