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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05027867




Registration number
NCT05027867
Ethics application status
Date submitted
25/08/2021
Date registered
30/08/2021
Date last updated
16/08/2023

Titles & IDs
Public title
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Scientific 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)
Secondary ID [1] 0 0
KRT-232-112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small-cell Lung Cancer 0 0
Small Cell Lung Carcinoma 0 0
Small Cell Lung Cancer Extensive Stage 0 0
Small Cell Lung Cancer Recurrent 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KRT-232

Experimental: Arm 1 - KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

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


Treatment: Drugs: KRT-232
Administered by mouth
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) of each arm
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Duration of response (DOR) of each arm
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Progression-free survival (PFS) of each arm
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Overall survival (OS) of each arm
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Disease control rate (DCR) of each arm
Timepoint [4] 0 0
24 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2022
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
France
State/province [6] 0 0
France/Haut-Rhin
Country [7] 0 0
France
State/province [7] 0 0
Maine-et-Loire
Country [8] 0 0
France
State/province [8] 0 0
Rhône
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Grenoble
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
Germany
State/province [12] 0 0
Baden-Württemberg
Country [13] 0 0
Germany
State/province [13] 0 0
Hessen
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Hungary
State/province [15] 0 0
Bács-Kiskun
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Chungcheongbuk-do
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeonggido
Country [18] 0 0
Spain
State/province [18] 0 0
Navarra
Country [19] 0 0
Spain
State/province [19] 0 0
Alicante
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
Spain
State/province [24] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kartos Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05027867
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05027867