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HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

NCT03284502 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-08-01

No results posted yet for this study

Summary

This study evaluates the safety, tolerability and pharmacokinetics of HM95573 In combination with either cobimetinib or cetuximab in patients with locally advanced or metastatic solid tumors.

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

DRUG

HM95573, cobimetinib

Regimen: twice daily (BID), continuous dosing for HM95573, once daily (QD) 21 days, 7 days off for cobimetinib

DRUG

HM95573, cetuximab

Regimen: twice daily (BID), continuous dosing for HM95573

DRUG

HM95573, cobimetinib

Regimen: Recommended dose (RD) and schedule selected based on the data of safety, tolerability, pharmacokinetics, and anti-tumor activity tested in Stage 1

DRUG

HM95573, cetuximab

Regimen: Expansion dose of HM95573 selected based on the data of safety and tolerability tested in Stage 1b

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2024-09-30
Completion
2024-12-31

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 NCT03284502 on ClinicalTrials.gov