Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 11

643P - A phase Ib/IIa study to assess the safety, tolerability, pharmacokinetics, and antitumor activity of YYB101, hepatocyte growth factor neutralizing humanized monoclonal antibody, in combination with irinotecan in metastatic or recurrent colorectal cancer patients (NOV110501-201)

Date

21 Oct 2023

Session

Poster session 11

Topics

Clinical Research;  Cancer Biology;  Translational Research;  Targeted Therapy

Tumour Site

Colon and Rectal Cancer

Presenters

Yongjun Cha

Citation

Annals of Oncology (2023) 34 (suppl_2): S410-S457. 10.1016/S0923-7534(23)01935-X

Authors

Y. Cha1, S. Song2, J.Y. Choi2, Y.W. Park3, H. Lee4, S. Lee5, M.A. Lee6, J. Lee7

Author affiliations

  • 1 Division Of Medical Oncology, Center For Colorectal Cancer, National Cancer Center - Graduate School of Cancer Science and Policy, 10408 - Goyang/KR
  • 2 Clinical Development Team, CellabMED Co., Ltd., Seoul/KR
  • 3 Oncology Drug Development & Business Development, National OncoVenture, Goyang/KR
  • 4 Oncology Drug Development & Business Development, National OncoVenture, 10408 - Goyang/KR
  • 5 Department Of Clinical Pharmacology And Therapeutics, Seoul National University Hospital, 110-744 - Seoul/KR
  • 6 5division Of Medical Oncology, Department Of Internal Medicine, Cancer Research Institute, College Of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, 137-701 - Seoul/KR
  • 7 6division Of Hematology/oncology, Department Of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 643P

Background

The hepatocyte growth factor (HGF)/MET pathway is implicated in tumorigenesis and treatment resistance of colorectal cancer (CRC). This report presents final results of a multi-center phase Ib/IIa study investigating biweekly YYB101, an anti-HGF monoclonal antibody, combined with irinotecan in refractory metastatic/recurrent CRC.

Methods

Eligible patients had metastatic/recurrent CRC with disease progression <6 months from the last irinotecan dose. phase Ib determined the recommended phase II dose (RP2D) of YYB101 with irinotecan (150 mg/m2), starting at 20 mg/kg, focusing on dose-limiting toxicities (DLT) incidence. Phase IIa assessed objective response rate (ORR) as the primary endpoint, with secondary endpoints including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, and pharmacokinetics. Archival tissue specimens and serial blood samples were collected for exploratory analysis.

Results

Thirty-five patients, aged 42-73 (median: 56), were enrolled. All had received ≥3 prior therapy lines (42.9% ≥4 lines). No DLTs were reported in phase Ib, with 20 mg/kg YYB101 selected as RP2D. In phase IIa, ORR was 5.7% (2/35) [95% confidence interval (CI), 0.70–19.16], and DCR was 82.9% (95% CI, 66.4–99.4). Median PFS was 4.80 months (95% CI, 3.15-8.84), and median OS was 14.9 months (95% CI, 9.30–not reached). Adverse events were generally manageable, mostly grades 1-2. During the COVID-19 pandemic, 54.3% of patients skipped one or two YYB101 doses but maintained serum concentrations above the predicted minimum effective concentration (100 μg/ml).

Conclusions

The YYB101 and irinotecan combination showed modest efficacy and tolerable adverse events in refractory metastatic/recurrent CRC. Ongoing biomarker analyses aim to identify genomic and transcriptomic variables associated with long-term disease control.

Clinical trial identification

NCT04368507.

Editorial acknowledgement

Legal entity responsible for the study

National OncoVenture, National Cancer Center, Goyang, Korea; CellabMED Inc, Seoul, Korea.

Funding

National OncoVenture and National Cancer Center, funded by the Ministry of Health and Welfare, Republic of Korea (Grant No. HI11C1191); CellabMED Inc, Seoul, Korea.

Disclosure

Y. Cha: Financial Interests, Personal, Advisory Board: IMBdx, Inc.; Financial Interests, Personal, Invited Speaker: Roche, MSD Korea; Financial Interests, Personal, Other, Consulting fee: Ono Pharmaceutical, GC Genome Corporation, Boryung Pharmaceutical, Interpark Bioconvergence Corp.; Non-Financial Interests, Principal Investigator: CellabMED Co., Ltd.; Non-Financial Interests, Advisory Role: National OncoVenture, Goyang, Korea; Non-Financial Interests, Member: Korean Society of Medical Oncology, SWOG, Korean Society of Medical Oncology, Korean Cancer Association, American Association for Cancer Research, American Society of Clinical Oncology. S. Song, J.Y. Choi: Financial Interests, Personal, Full or part-time Employment: CellabMED Co., Ltd. Y.W. Park: Financial Interests, Personal, Ownership Interest: Avelos Therapeutics. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.