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

21 days ago

Trial completion date • Trial primary completion date

MSI (Microsatellite instability)

balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)

27d

Molecular complete response to the RIN protocol (regorafenib, ipilimumab, and nivolumab) in a patient with advanced recurrent metastatic mismatch repair proficient/microsatellite stable (pMMR/MSS) rectal cancer. (PubMed, Ther Adv Med Oncol)

Rectal cancer recurrence remains a major therapeutic challenge, particularly in patients unresponsive to conventional regimens. While previous studies have demonstrated limited benefit of immunotherapy in this tumor subtype, the present findings suggest an emerging therapeutic opportunity that warrants prospective evaluation to confirm efficacy, explore the mechanistic basis, and identify biomarkers predictive of durable response beyond the absence of liver metastases. More effective combinatorial regimens like zanzalintinib and atezolizumb (STELLAR-303) trial, as well as newer generation of CTLA-4 inhibitors like botensilimab, vilastobart, and muzastotug are showing more promise for patients with MSS colorectal cancers in particular who do not have liver metastases (NLM).

27 days ago

Journal • Mismatch repair • PD(L)-1 Biomarker • IO biomarker • pMMR

KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)

KRAS mutation • KRAS G12D • KRAS G12

Opdivo (nivolumab) • Yervoy (ipilimumab) • Stivarga (regorafenib) • botensilimab (AGEN1181) • vilastobart (XTX101) • muzastotug (ADG126) • zanzalintinib (XL092)

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (clinicaltrials.gov)

P2, N=197, Recruiting, Gruppo Oncologico del Nord-Ovest | N=140 --> 197

1 month ago

Enrollment change

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • POLD1 (DNA Polymerase Delta 1)

HER-2 positive • MSI-H/dMMR • KRAS G12C • HER-2 amplification • HER-2 mutation • MET amplification • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type

Opdivo (nivolumab) • Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • vorbipiprant (CR6086)

2ms

NEOASIS: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations (clinicaltrials.gov)

P2/3, N=133, Recruiting, The Netherlands Cancer Institute | N=92 --> 133

2 months ago

Enrollment change • Pan tumor

MSI-H/dMMR

docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)

2ms

CIME/ET23-185: Study aiming to compare the survival of patients with locally advanced or metastatic MSI/dMMR Esogastric adenocarcinomas treated by a combination of Immune checkpoint inhibitors (botensilimab + balstilimab) versus the standard of care (FOLFOX/XELOX + nivolumab) (2023-506291-28-00)

P2/3, N=132, Recruiting, Centre Leon Berard | Not yet recruiting --> Recruiting

2 months ago

Enrollment open • Checkpoint inhibition • dMMR

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)

PD-L1 expression • MSI-H/dMMR • HER-2 negative

Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)

2ms

BATTMAN: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma (clinicaltrials.gov)

P3, N=834, Recruiting, Canadian Cancer Trials Group | Not yet recruiting --> Recruiting

2 months ago

Enrollment open

balstilimab (AGEN2034) • botensilimab (AGEN1181)

2ms

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis (clinicaltrials.gov)

P1, N=10, Recruiting, Northwell Health | Not yet recruiting --> Recruiting

2 months ago

Enrollment open

Avastin (bevacizumab) • 5-fluorouracil • doxorubicin hydrochloride • irinotecan • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN2373

3ms

BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov)

P2, N=16, Active, not recruiting, Nicholas DeVito, MD | Recruiting --> Active, not recruiting

3 months ago

Enrollment closed

MSI (Microsatellite instability)

MSI-H/dMMR

Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)

3ms

ARCITECT: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (clinicaltrials.gov)

P2, N=120, Suspended, Michael B. Atkins, MD | Trial completion date: Oct 2026 --> Nov 2027 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Nov 2026

3 months ago

Trial completion date • Trial suspension • Trial primary completion date

CD4 (CD4 Molecule)

Opdivo (nivolumab) • Yervoy (ipilimumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)