To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of YYB101 With Irinotecan, Patients Who Are Metastatic or Recurrent Colorectal Cancer Patients

NCT04368507 | Completed Phase 1

• 1 other identifier: NOV110501-201
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of YYB101 with Irinotecan, patients who are metastatic or recurrent Colorectal Cancer Patients.

Conditions

Colorectal Cancer Metastatic; Colorectal Cancer Recurrent

Outcome Measures

Primary Outcomes (2)

• 1b (Dose level 0) cohort: Safety, Tolerability of YYB101 by DLTs and MTD

  DLTs and MTD

  28 days

• 2a cohort: Safety, Tolerability of YYB101 by ORR

  ORR

  By 12 months after enrollment of the last subject

Secondary Outcomes (13)

• 1b (Dose level 0) cohort

  By 12 months after enrollment of the last subject

• 1b (Dose level 0) cohort

  By 12 months after enrollment of the last subject

• 1b (Dose level 0) cohort

  By 12 months after enrollment of the last subject

• 1b (Dose level 0) cohort

  By 12 months after enrollment of the last subject

• 1b (Dose level 0) cohort

  By 12 months after enrollment of the last subject

Study Arms (1)

YYB101+Irinotecan

EXPERIMENTAL

1. b (Dose level 0 cohort): YYB101 20mg/kg, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks 2. a Stage 1: YYB101 RP2D, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks

Drug: YYB101

Interventions

YYB101 DRUG

1. b (Dose level 0 cohort): YYB101 20mg/kg, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity 2. a Stage 1: YYB101 RP2D, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity

YYB101+Irinotecan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged ≥ 19 years
• Patients with histologically confirmed metastatic or recurrent colorectal cancer
• Patients who progressed after standard anticancer treatment including existing fluoropyrimidine, oxaliplatin, and irinotecan
• Patients who received anticancer treatment including irinotecan for at least 6 weeks, with progression confirmed radiologically while on anticancer treatment or within 6 months (24 weeks) after completion of anticancer treatment
• Adjuvant therapy is acknowledged as an anticancer therapy, if PD is confirmed within 6 months (24 weeks) after the last dose
• Patients who are unable to undergo radical resection 3) Patients with Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 4) Patients with life expectancy of at least 12 weeks 5) Patients with confirmed adequate hematologic, renal and hepatic function based on the following criteria:
• ANC ≥ 1,500/μL (without granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to baseline)
• Platelet ≥ 100,000/μL (without transfusion within 2 weeks prior to baseline)
• Hemoglobin ≥ 9 g/dL (without transfusion within 4 weeks prior to baseline)
• Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (eGFR) (or GFR) ≥ 60 mL/min/1.73 m2
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST and ALT ≤ 5 X ULN for subjects with confirmed hepatic metastases)
• Total bilirubin ≤ 1.5 X ULN
• Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN
• Urine protein to creatinine ratio (UPC) \< 1.0 0 (g/g)a a UPC will be conducted only when urine dipstick protein level is ≥ 1 positive (+).
• \. Patients with a measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 7. Patients who voluntarily agree to participate in the study and sign the informed consent form

You may not qualify if:

• Patients with hematologic malignancy including lymphoma
• Patients who received chemotherapy, biological therapy, immunotherapy (including immune checkpoint inhibitors), or radiotherapy within 4 weeks prior to baseline for the treatment of metastatic or recurrent colorectal cancer (Participation is not allowed if nitrosoureas or mitomycin is administered within 6 weeks prior to baseline or if biological target antibody is administered within 8 weeks prior to baseline)
• Patients with a history of primary malignancy other than colorectal cancer. However, the patients are permitted to participate if:
• They have not received any treatment for the tumor or are disease-free for at least 5 years (For papillary carcinoma of thyroid, participation in the study is allowed even if it has not been more than 5 years after radical resection.)
• At least 1 year has passed since complete resection of basal/squamous cell carcinoma of the skin or successful treatment of cervical carcinoma in situ
• Patients with symptomatic central nervous system metastases (except for patients who have discontinued systemic corticosteroid treatment at least 4 weeks prior to baseline and are neurologically stable for at least 4 weeks)
• Patients with the following medical or surgical/procedural history
• Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
• History of infection with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) within 6 months (24 weeks) prior to baseline
• History of acute coronary syndrome (unstable angina or myocardial infarction) within 6 months (24 weeks) prior to baseline
• Serious cerebrovascular disease such as stroke within 6 months (24 weeks) prior to baseline
• Major surgery that requires general anesthesia or a ventilation assist within 4 weeks prior to baseline (within 2 weeks for video-assisted thoracoscopic surgery \[VATS\] or open-and-closed \[ONC\] surgery)
• Patients with any of the following diseases:
• New York Heart Association (NYHA) class III or IV heart failure
• Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 90 mmHg despite drug treatments)

Sponsors & Collaborators

• CellabMED: lead
• Yooyoung Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

National Cancer Center

Seoul, Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Seoul ST. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

Location

MeSH Terms

Interventions

monoclonal antibody YYB-101

Study Officials

• Hoonkyo Kim, Ph.D

  National OncoVenture/National Cancer Center

  STUDY DIRECTOR

• Garam Im

  National OncoVenture/National Cancer Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: April 29, 2020
• Study Start: August 9, 2019
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

KR (3)