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

Phase 2

Terminated

• Conditions: Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent
• Interventions: Drug: KRT-232

• Registration Number: NCT05027867
• Lead Sponsor: Kartos Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-30
• Study Start: 2021-12-06
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	KRT-232	KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Arm 1	KRT-232	KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) of each arm	24 weeks	The proportion of subjects achieving partial response or better per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) of each arm	1 year	Time from first dose to disease progression or death
Duration of response (DOR) of each arm	1 year	Time from initiation of response to disease progression or death
Disease control rate (DCR) of each arm	24 weeks	The proportion of subjects achieving stable disease or better per RECIST 1.1
Overall survival (OS) of each arm	1 year	Time from first dose to death

Trial Locations

Locations (33)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

EDOG - Institut Bergonie - PPDS; 🇫🇷 Bordeaux, France

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Regional Universitario de Malaga - Hospital Civil; 🇪🇸 Málaga, Spain

Hospital Universitario Vall d'Hebrón - PPDS; 🇪🇸 Barcelona, Spain

Clinica Universidad Navarra - Madrid; 🇪🇸 Madrid, Spain

Mark H Zangmeister Center - 3100 Plaza Properties Boulevard; 🇺🇸 Columbus, Ohio, United States

Florida Cancer Specialists - 560 Jackson St, Suite 220; 🇺🇸 Saint Petersburg, Florida, United States

Northwest Georgia Oncology Centers; 🇺🇸 Marietta, Georgia, United States

Hôpital Louis Pradel; 🇫🇷 Bron, Rhône, France

Hematology Oncology Clinic; 🇺🇸 Baton Rouge, Louisiana, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Edog - Ico - Ppds; 🇫🇷 Angers, Maine-et-Loire, France

Hospital Universitario 12 de Octubre; 🇪🇸 Alicante, Spain

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Chungcheongbuk-do, Korea, Republic of

Hospital Universitari i Politecnic La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

SCRI Tennessee Oncology Nashville; 🇺🇸 Nashville, Tennessee, United States

Centre Hospitalier de Mulhouse - Hopital Emile Muller; 🇫🇷 Mulhouse, France/Haut-Rhin, France

Florida Cancer Specialists; 🇺🇸 West Palm Beach, Florida, United States

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Florida Cancer Specialists - 3840 Broadway; 🇺🇸 Fort Myers, Florida, United States

CHU de Grenoble; 🇫🇷 Grenoble, France

Klinik für Kardiologie, Angiologie und Pneumologie; 🇩🇪 Esslingen am Neckar, Baden-Württemberg, Germany

Hôpital de La Croix Rousse; 🇫🇷 Pierre-Bénite, Rhône, France

SCRI Tennessee Oncology Chattanooga; 🇺🇸 Chattanooga, Tennessee, United States

Evangelische Lungenklinik Berlin; 🇩🇪 Berlin, Germany

Hospices Civils de Lyon; 🇫🇷 Lyon, Rhône, France

Hopital Nord AP-HM; 🇫🇷 Marseille, France

Lungenfachklinik Immenhausen; 🇩🇪 Immenhausen, Hessen, Germany

Bacs Kiskun Megyei Korhaz; 🇭🇺 Kecskemét, Bács-Kiskun, Hungary

CHA Bundang Medical Center, CHA University; 🇰🇷 Seongnam-si, Gyeonggido, Korea, Republic of

Clinica Universidad Navarra; 🇪🇸 Pamplona, Navarra, Spain