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DRUG CLASS:

CTLA4 antagonist

6d
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
P2, N=24, Recruiting, Weill Medical College of Cornell University | Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
Trial completion date • Trial primary completion date
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MSI (Microsatellite instability)
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balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
11d
RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
P2, N=211, Terminated, Agenus Inc. | Active, not recruiting --> Terminated; Sponsor strategic decision
Trial termination
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balstilimab (AGEN2034) • zalifrelimab (UGN-301)
21d
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov)
P1, N=36, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Sep 2026
Trial completion date • Trial primary completion date • Checkpoint inhibition • First-in-human
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balstilimab (AGEN2034) • zalifrelimab (UGN-301)
1m
Enrollment change • Pan tumor
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MSI-H/dMMR
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docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
1m
Enrollment open • Checkpoint inhibition • dMMR
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
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PD-L1 expression • MSI-H/dMMR • HER-2 negative
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Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
1m
Enrollment open
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balstilimab (AGEN2034) • botensilimab (AGEN1181)
2ms
New P2 trial
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • ALK rearrangement
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PD-L1 IHC 22C3 pharmDx
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carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
2ms
BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov)
P2, N=16, Active, not recruiting, Nicholas DeVito, MD | Recruiting --> Active, not recruiting
Enrollment closed
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
2ms
New trial
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Qibeian (iparomlimab/tuvonralimab)
2ms
Trial completion date
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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BRAF wild-type
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Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
2ms
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
P2, N=65, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2026 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
Trial completion date • Trial primary completion date • Checkpoint inhibition
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pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
3ms
BATTMAN: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma (clinicaltrials.gov)
P3, N=834, Not yet recruiting, Canadian Cancer Trials Group | Initiation date: Nov 2025 --> Feb 2026
Trial initiation date
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balstilimab (AGEN2034) • botensilimab (AGEN1181)