Non Small Cell Lung CancerPhase 1NCT04849273
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
A Phase 1 study testing TPX-0131 in people with Non Small Cell Lung Cancer and Non-Small Cell Lung Cancer, run by Turning Point Therapeutics, Inc. at 15 sites in 3 countries.
Trial summary
A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC
- What is being tested?
- TPX-0131
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 28 Jul 2021to 18 Apr 2023
- Phase
- Phase 1
- 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
- Age ≥ 18 (or as required by local regulation).
- Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
- Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
- ECOG performance status ≤ 1.
- Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
- Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
- Adequate organ function.
Who cannot join
- Major surgery within four weeks of the start of TPX-0131 treatment.
- Clinically significant cardiovascular disease
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
- Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
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- Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
- Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
- Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States7 sites
Local Institution - 2105
Aurora, Colorado, 80045
Local Institution - 2106
Boston, Massachusetts, 02114-2696
Local Institution - 2108
Boston, Massachusetts, 02215
Local Institution - 2102
Fairfax, Virginia, 22031-4629
Local Institution - 2103
Hackensack, New Jersey, 07601
Local Institution - 2107
Nashville, Tennessee, 37203
Local Institution - 2104
Orange, California, 92868
Australia4 sites
Local Institution - 6102
Blacktown, New South Wales, 2148
Local Institution - 6103
Heidelberg, Victoria, 3084
Local Institution - 6104
Melbourne, Victoria, 3000
Local Institution - 6101
Nedlands, Western Australia, 6009
South Korea4 sites
Local Institution - 6303
Seoul, Seoul-teukbyeolsi, 05505
Local Institution - 6301
Seoul, 03722
Local Institution - 6302
Seoul, 06351
Local Institution - 6304
Seoul, 110-744
About this study
Official title: A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).
Read the detailed description
Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.
- Conditions
- Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Solid Tumor, Metastatic Solid Tumor, ALK Gene Mutation
- Being tested
- TPX-0131
- Keywords
- Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Advanced/metastatic disease, Lung cancer, Metastatic solid tumor, Advanced solid tumor, ALK gene fusion, ALK inhibitor, TPX-0131, ALK TKI, ALK Tyrosine Kinase Inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-0131Drug
Oral TPX-0131 tablets
| Study group | Role | What they receive |
|---|---|---|
| TPX-0131 | Experimental | The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131. Receives: Drug: TPX-0131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Evaluate the safety and tolerability of TPX-0131
Measured: Within 28 days of the first TPX-0131 dose for each patient
Define the Recommended Phase 2 Dose
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
Measured: Approximately 24 months
Secondary outcomes (1)
Adverse events (AEs)
Evaluate the overall safety profile of TPX-0131
Measured: Approximately 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start28 Jul 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Why it stopped: Adverse change in the risk/benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849273
- Sponsor's protocol ID
- CA226-1036
- Other IDs
- CA226-1036, TPX-0131-01
- Status last verified
- May 2023
- First submitted
- 12 Apr 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT04849273
- Acronym / sponsor ID
- CA226-1036
- Conditions
- Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Solid Tumor, Metastatic Solid Tumor, ALK Gene Mutation
- Keywords
- Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Advanced/metastatic disease, Lung cancer, Metastatic solid tumor, Advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse change in the risk/benefit.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Turning Point Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 19 Apr 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.
A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed description
Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPX-0131 | Experimental | Drug: TPX-0131The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 (or as required by local regulation).
- Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
- Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
- ECOG performance status ≤ 1.
- Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
Key exclusion criteria (9 listed)
- Major surgery within four weeks of the start of TPX-0131 treatment.
- Clinically significant cardiovascular disease
- Any of the following cardiac criteria:
- Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
- Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
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 |
|---|---|---|
| TPX-0131Oral TPX-0131 tablets | Drug | TPX-0131 |
Primary outcome
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Time frame: Within 28 days of the first TPX-0131 dose for each patient
Evaluate the safety and tolerability of TPX-0131
Define the Recommended Phase 2 Dose
Time frame: Approximately 24 months
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
1 secondary outcome
Adverse events (AEs)
Time frame: Approximately 34 months
Results and safety
The study was stopped early (reason given: Adverse change in the risk/benefit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPX-0131 in people with Non Small Cell Lung Cancer and Non-Small Cell Lung Cancer, run by Turning Point Therapeutics, Inc. at 15 sites in 3 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 7 inclusion and 9 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Adverse change in the risk/benefit.). 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?
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131 (time frame: Within 28 days of the first TPX-0131 dose for each patient). The study lists 2 primary outcomes in all. 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 26 May 2023.