Small-cell Lung CancerPhase 2NCT05027867
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
A Phase 2 study testing KRT-232 in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Kartos Therapeutics, Inc. at 33 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage
- What is being tested?
- KRT-232
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 6 Dec 2021to 26 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
United States9 sites
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
Columbus, Ohio, 43213
Florida Cancer Specialists - 3840 Broadway
Fort Myers, Florida, 33901
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, 37205
Florida Cancer Specialists - 560 Jackson St, Suite 220
St. Petersburg, Florida, 33705
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Spain9 sites
Hospital Universitario 12 de Octubre
Alicante, 28007
Hospital General Universitario de Alicante
Alicante, 3010
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 0825
Clinica Universidad Navarra - Madrid
Madrid, 28027
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Malaga - Hospital Civil
Málaga, 29011
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Hospital Universitario Virgen Macarena
Seville, 41071
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
France8 sites
Edog - Ico - Ppds
Angers, Maine-et-Loire, 49933
EDOG - Institut Bergonie - PPDS
Bordeaux, 33000
Hôpital Louis Pradel
Bron, Rhône, 69677
CHU de Grenoble
Grenoble, 38043
Hospices Civils de Lyon
Lyon, Rhône, 69495
Hopital Nord AP-HM
Marseille, 13915
Centre Hospitalier de Mulhouse - Hopital Emile Muller
Mulhouse, France/Haut-Rhin, 68000
Hôpital de La Croix Rousse
Pierre-Bénite, Rhône, 69310
Germany3 sites
Evangelische Lungenklinik Berlin
Berlin, 13125
Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, Baden-Wurttemberg, 73730
Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376
South Korea2 sites
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, 13520
About this study
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)
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.
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
- Being tested
- KRT-232
- Keywords
- navtemadlin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRT-232Drug
Also called navtemadlin
Administered by mouth
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) Receives: Drug: KRT-232 |
| Arm 2 | Experimental | KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) Receives: Drug: KRT-232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of each arm
The proportion of subjects achieving partial response or better per RECIST 1.1
Measured: 24 weeks
Secondary outcomes (4)
Duration of response (DOR) of each arm
Time from initiation of response to disease progression or death
Measured: 1 year
Progression-free survival (PFS) of each arm
Time from first dose to disease progression or death
Measured: 1 year
Overall survival (OS) of each arm
Time from first dose to death
Measured: 1 year
Disease control rate (DCR) of each arm
The proportion of subjects achieving stable disease or better per RECIST 1.1
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start6 Dec 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Why it stopped: Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027867
- Sponsor's protocol ID
- KRT-232-112
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05027867
- Acronym / sponsor ID
- KRT-232-112
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
- Keywords
- navtemadlin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kartos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: KRT-232KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) |
| Arm 2 | Experimental | Drug: KRT-232KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRT-232Also: navtemadlinAdministered by mouth | Drug | Arm 1, Arm 2 |
Primary outcome
Objective response rate (ORR) of each arm
Time frame: 24 weeks
The proportion of subjects achieving partial response or better per RECIST 1.1
4 secondary outcomes
Duration of response (DOR) of each arm
Time frame: 1 year
Progression-free survival (PFS) of each arm
Time frame: 1 year
Overall survival (OS) of each arm
Time frame: 1 year
Disease control rate (DCR) of each arm
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KRT-232 in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Kartos Therapeutics, Inc. at 33 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Spain, France, Germany, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unanticipated and extremely high screen failure rate. There was no evidence of safety concerns in the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) of each arm (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.