Clinical trial NCT05027867: KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small-cell Lung Cancer
Small Cell Lung Carcinoma
Small Cell Lung Cancer Extensive Stage
Small Cell Lung Cancer Recurrent
Keywords: navtemadlin
Lead sponsor: Kartos Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR) of each arm
timeFrame: 24 weeks
Secondary outcomes:
measure: Duration of response (DOR) of each arm
timeFrame: 1 year
measure: Progression-free survival (PFS) of each arm
timeFrame: 1 year
measure: Overall survival (OS) of each arm
timeFrame: 1 year
measure: Disease control rate (DCR) of each arm
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - 3840 Broadway
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - 560 Jackson St, Suite 220
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
state: Ohio
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: SCRI Tennessee Oncology Nashville
state: Tennessee
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller
state: France/Haut-Rhin
city: Angers
country: France
facility: Edog - Ico - Ppds
state: Maine-et-Loire
city: Bron
country: France
facility: Hôpital Louis Pradel
state: Rhône
city: Lyon
country: France
facility: Hospices Civils de Lyon
state: Rhône
city: Pierre-Bénite
country: France
facility: Hôpital de La Croix Rousse
state: Rhône
city: Bordeaux
country: France
facility: EDOG - Institut Bergonie - PPDS
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille
country: France
facility: Hopital Nord AP-HM
city: Esslingen am Neckar
country: Germany
facility: Klinik für Kardiologie, Angiologie und Pneumologie
state: Baden-Württemberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
state: Hessen
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Kecskemét
country: Hungary
facility: Bacs Kiskun Megyei Korhaz
state: Bács-Kiskun
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón - PPDS
city: Madrid
country: Spain
facility: Clinica Universidad Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital Civil
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
Study officials:
References: