KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Small-cell Lung Cancer Clinical Trial

Official title:

An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05027867
• Other study ID #: KRT-232-112
• Status: Terminated
• Phase: Phase 2
• Start date: December 6, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: August 2023
• Source: Kartos Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT

• Disease must be measurable per RECIST Version 1.1

• Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.

• Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.

• ECOG = 2

Exclusion Criteria:

• Symptomatic or uncontrolled central nervous system (CNS) metastases.

• Prior treatment with MDM2 inhibitors

• Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment

• Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

• History of major organ transplant

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Extensive Stage
• Small Cell Lung Cancer Recurrent
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• KRT-232
Administered by mouth

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
France	Edog - Ico - Ppds	Angers	Maine-et-Loire
France	EDOG - Institut Bergonie - PPDS	Bordeaux
France	Hôpital Louis Pradel	Bron	Rhône
France	CHU de Grenoble	Grenoble
France	Hospices Civils de Lyon	Lyon	Rhône
France	Hopital Nord AP-HM	Marseille
France	Centre Hospitalier de Mulhouse - Hopital Emile Muller	Mulhouse	France/Haut-Rhin
France	Hôpital de La Croix Rousse	Pierre-Bénite	Rhône
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Klinik für Kardiologie, Angiologie und Pneumologie	Esslingen am Neckar	Baden-Württemberg
Germany	Lungenfachklinik Immenhausen	Immenhausen	Hessen
Hungary	Bacs Kiskun Megyei Korhaz	Kecskemét	Bács-Kiskun
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggido
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario 12 de Octubre	Alicante
Spain	Hospital Universitario Vall d'Hebrón - PPDS	Barcelona
Spain	Clinica Universidad Navarra - Madrid	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Regional Universitario de Malaga - Hospital Civil	Málaga
Spain	Clinica Universidad Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	SCRI Tennessee Oncology Chattanooga	Chattanooga	Tennessee
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Mark H Zangmeister Center - 3100 Plaza Properties Boulevard	Columbus	Ohio
United States	Florida Cancer Specialists - 3840 Broadway	Fort Myers	Florida
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	SCRI Tennessee Oncology Nashville	Nashville	Tennessee
United States	Florida Cancer Specialists - 560 Jackson St, Suite 220	Saint Petersburg	Florida
United States	Florida Cancer Specialists	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kartos Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Hungary,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) of each arm	The proportion of subjects achieving partial response or better per RECIST 1.1	24 weeks
Secondary	Duration of response (DOR) of each arm	Time from initiation of response to disease progression or death	1 year
Secondary	Progression-free survival (PFS) of each arm	Time from first dose to disease progression or death	1 year
Secondary	Overall survival (OS) of each arm	Time from first dose to death	1 year
Secondary	Disease control rate (DCR) of each arm	The proportion of subjects achieving stable disease or better per RECIST 1.1	24 weeks