^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    irinotecan

    i
    Other names: CPT-11, CPT 11, DQ 2805, IHL-305, SN 38B11, U 101440E
    Company:
    Generic mfg.
    Drug class:
    Topoisomerase I inhibitor
    Related drugs:
    1d
    D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=195, Recruiting, InnoPharmax Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR (Fibroblast Growth Factor Receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • TMB-H • KRAS G12C • BRAF mutation • KRAS G12
    |
    5-fluorouracil • capecitabine • irinotecan • leucovorin calcium • gemcitabine oral (D07001)
    1d
    A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=81, Completed, Agenus Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • botensilimab (AGEN1181)
    1d
    AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=128, Completed, Akeso | Trial completion date: Mar 2024 --> May 2026 | Trial primary completion date: Mar 2023 --> May 2026 | Recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    cisplatin • paclitaxel • docetaxel • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • Kaitanni (cadonilimab) • ligufalimab (AK117)
    3d
    Plasma PlGF as a Potential Biomarker in Ramucirumab-Based Second-Line Therapy for Advanced Gastroesophageal Adenocarcinoma: Exploratory Biomarker Analysis from the Phase II Part of the RAMIRIS Trial. (PubMed, Int J Cancer)
    The phase II RAMIRIS trial compared RAM plus paclitaxel with RAM plus FOLFIRI (5-fluororuracil, leucovorin and irinotecan) in this setting...Elevated PlGF-particularly its early increase during RAM-based therapy-was associated with shortened survival and may represent a dynamic marker of unfavorable prognosis in advanced gastric/GEJ adenocarcinoma. Given the exploratory nature of this analysis, these findings should be considered hypothesis-generating and require validation in independent biomarker-driven studies.
    P2 data • Journal
    |
    CA9 (Carbonic anhydrase 9)
    |
    paclitaxel • 5-fluorouracil • Cyramza (ramucirumab) • irinotecan • leucovorin calcium
    3d
    DPYD and UGT1A1 Genotype-Based Dosing for Fluoropyrimidines and Irinotecan Chemotherapy: Variant-Specific Impact on Treatment Intensity and Toxicity. (PubMed, Int J Cancer)
    In UGT1A1*28 homozygous carriers, genotype-driven dosing reduced toxicity (21.1% vs. 45.7%, p = 0.086) while preserving comparable RDI (58% [IQR 50-69] vs. 61% [IQR 41-76], p = 0.906). These findings suggest uniform genotype-based strategies may not fully capture variant-specific effects, particularly for DPYD c.1236G>A (HapB3), supporting more flexible dosing approaches.
    Journal
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1) • DPYD (Dihydropyrimidine Dehydrogenase)
    |
    irinotecan
    3d
    3082-CL-0301: A study to confirm the safety of ASP3082, and if it delays tumor growth in people with pancreatic cancer, when given with either mFOLFIRINOX or NALIRIFOX chemotherapies (2025-523684-38-00)
    P2/3, N=35, Not yet recruiting, Astellas Pharma Global Development Inc.
    New P2/3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan)
    3d
    A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations (clinicaltrials.gov)
    P1, N=448, Recruiting, Alterome Therapeutics, Inc. | N=188 --> 448
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • oxaliplatin • irinotecan • leucovorin calcium • midazolam hydrochloride
    3d
    A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis. (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • irinotecan
    3d
    CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov)
    P3, N=450, Recruiting, Amgen | Trial completion date: Aug 2031 --> Apr 2032 | Trial primary completion date: Jan 2028 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • Lumakras (sotorasib) • irinotecan • leucovorin calcium • Mvasi (bevacizumab-awwb)
    3d
    INTEGRATEIIb: RegoNivo vs Standard of Care Chemotherapy in AGOC (clinicaltrials.gov)
    P3, N=462, Completed, Australasian Gastro-Intestinal Trials Group | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Opdivo (nivolumab) • docetaxel • albumin-bound paclitaxel • Stivarga (regorafenib) • irinotecan • Lonsurf (trifluridine/tipiracil)
    3d
    KEYNOTE-E59: A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=226, Terminated, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Terminated; Lack of clinical benefit
    Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 underexpression
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • docetaxel • 5-fluorouracil • pemetrexed • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • ASP1570
    4d
    SYNCHRONOX: FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases (clinicaltrials.gov)
    P=N/A, N=550, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium