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MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors

NCT04262739 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-10-20

No results posted yet for this study

Summary

The objectives of this study are:

Part 1:

* To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies.
* To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P.

Part 2:

* To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies
* To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.

Conditions

Interventions

DRUG

NYH817G

Subject will orally administer NYH817G (15 mg) during the cycles(21 days)

DRUG

NYH100P

Subject will orally administer NYH100P (100 mg) during the cycles(21 days)

DRUG

NYH817G and NYH100P

Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)

Sponsors & Collaborators

  • Haim Bio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Minkyu Jung., MD.,Ph.D. · Div. of Medical Oncology. Yonsei Cancer Center.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT04262739 on ClinicalTrials.gov