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

NCT04368507 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

DRUG

YYB101

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

Sponsors & Collaborators

  • Yooyoung Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • CellabMED

    lead INDUSTRY

Principal Investigators

  • Hoonkyo Kim, Ph.D · National OncoVenture/National Cancer Center

  • Garam Im · National OncoVenture/National Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-12-21
Completion
2021-12-21

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368507 on ClinicalTrials.gov