marked.bio

anti-PD-1 antibody · antibody

balstilimab

6 active trials across 4 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as AGEN2034.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
KRAS G12C 5 5 Phase 2
KRAS G12D 4 4 Phase 1/2
MSI-H / dMMR 2 3 Phase 3
BRAF V600E 0 1 –

Trials

6 of 8 trials shown

  1. Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

    Recruiting Phase 3 Centre Leon Berard Started 2025Primary completion 2028-05 NCT06346197

    balstilimabbotensilimabFOLFOXXELOXnivolumab FDA EU

    Patient with MSI-H/dMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesopha…

    MSI-H / dMMRGastric Cancer, MSI-H, Metastatic Cancer, Advanced Cancer

  2. Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

    Recruiting Phase 1/2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2025Primary completion 2028-12 NCT06782932

    AGEN2373balstilimabcyclophosphamideGVAXmKRASvax

    A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resec…

    KRAS G12CKRAS G12DPancreatic Cancer

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

    Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2023Primary completion 2027-05 NCT05845450

    trastuzumab deruxtecandurvalumabpanitumumab FDAbotensilimabbalstilimabsotorasib FDA EUVorbipiprantnivolumabamivantamab

    COHORT 8: pMMR/MSS status and KRAS G12C mutation, absence of HER2 overexpression/amplification and wild-type status for BRAF.

    KRAS G12CMSI-H / dMMRColorectal Cancer, Resectable Colorectal Carcinoma

  4. Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer

    Active, not recruiting Phase 2 University of Kansas Medical Center Started 2022Primary completion 2024-12 NCT05638698

    TG01QS-21balstilimab

    Screening tumor tissue positive or known pathogenic or likely pathogenic RAS mutation resulting in amino acid substitution in codon 12A, 12C, 12D, 12R, 12S or 13D .

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-09-23Pancreas Cancer

  5. Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer

    Recruiting Phase 1 University of Southern California Started 2025Primary completion 2027-01 NCT06336902

    balstilimabbotensilimab

    …cally confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act \[CLIA\]-certified lab), includin…

    KRAS G12CKRAS G12DMetastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8

  6. KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

    Recruiting Phase 1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2024Primary completion 2029-11 NCT06411691

    KRAS Vaccine with Poly-ICLC adjuvantbalstilimabbotensilimab

    Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor.

    KRAS G12CKRAS G12DColorectal Cancer, Pancreatic Cancer