Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

Triple Negative Breast Cancer Clinical Trial

Official title:

A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752723
• Other study ID #: GX-I7-CA-006
• Secondary ID: KEYNOTE-899MK-34
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 27, 2019
• Est. completion date: May 11, 2023

Study information

• Verified date: February 2024
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Key Inclusion Criteria:

1. Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) < 1% positive tumor nuclei, Progesterone Receptor (PR) < 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH).

2. Subject must have received anthracycline and taxane based chemotherapy for TNBC

3. Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology.

4. Female subjects, age = 19 years at the time of consent.

Key Exclusion Criteria:

1. Known severe hypersensitivity (= Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation.

2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.

Related Conditions & MeSH terms

• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• GX-I7
i.m.
• Pembrolizumab(KEYTRUDA®)
i.v.
• Cyclophosphamide
i.v.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul ST.Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou Medical Center	Suwon-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Genexine, Inc.	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of DLTs	To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab	during the first 5 weeks
Primary	Incidence, nature and severity of adverse events	graded according to NCI CTCAE v5.0	up to 24month
Primary	Objective response rate (ORR)	defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1	up to 24month