Advanced Breast CancerPhase 1NCT04097756

A Phase I Study of LX-039 Tablets

A Phase 1 study testing LX-039 tablets in people with Advanced Breast Cancer, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Advanced Breast Cancer
What is being tested?: LX-039 tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteChina
Study dates: 7 Jan 2020to 7 Feb 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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Be able to read and sign the informed consent form.
Adult females (aged ≥18 and ≤75 years).
Be diagnosed with breast cancer confirmed by pathological examination.
Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining).
Be postmenopausal.
Subjects who have previously received endocrine therapy and obtained benefit.

Show all 11Show fewer

ECOG(Eastern Cooperative Oncology Group) score ≤ 1.
Subjects in part2 of the study need to have measurable lesions that meet RECIST 1.1 criteria.
Has recovered from toxicity or injury from prior chemotherapy/radiotherapy .
Enough hematology and organ function.
Expected survival>3 months.

Who cannot join

Subjects with HER2-overexpressing breast cancer.
Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated.
Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications.
Subjects who received second-line or above chemotherapy.
Subjects with known allergy to this product or any of its components.
Subjects who previously used other estrogen receptor down regulators than fulvestrant.

Show all 16Show fewer

Subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry.
Subjects who received cell therapy or tumor vaccine therapy;
Subjects with severe immunosuppression .
Severe or uncontrolled disease.
Subjects with diseases or abnormalities that may affect the administration and absorption of drugs.
Subjects with other malignancy within 5 years prior to study entry.
Subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs.
Subjects with history of definite neurological or psychiatric disorders in the past.
Subjects who are HIV(human immunodeficiency virus) antibody positive, HBsAg(hepatitis B surface antigen) positive or HCV(hepatitis C virus)antibody positive.
Subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase I Study of LX-039 Tablets in Postmenopausal Patients With ER+, HER2- Advanced Breast Cancer After Failure of Endocrine Therapy

This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 ~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.

Conditions: Advanced Breast Cancer
Being tested: LX-039 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LX-039 tabletsDrug
orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, or study termination

Study groups in NCT04097756
Study group	Role	What they receive
Part1：dose escalation	Experimental	The investigational product for this study is LX-039 tablets,which can be administered orally. 6~8 ascending dose level until MTD and the specification included 50 mg, 100 mg, 200 mg, 400 mg, 600 mg , 800 mg,1050 mg and 1400 mg. LX-039 tablets will be administered in a therapeutic cycle of 28 days once a day orally. The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. Receives: Drug: LX-039 tablets
Part 2：dose expansion	Experimental	2~3 selected tolerable dose will be selected according to the tolerance and FES PET results of dose escalation phase.The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. Receives: Drug: LX-039 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

To explore the tolerance of LX-039 in ER +, HER2 - patients with advanced breast cancer
Incidence of dose limiting toxicities (DLTs)
Measured: DLT observation period(5 weeks for dose escalation, 4 weeks for dose expansion)

Secondary outcomes (33)

The safety of LX-039 in ER +, HER2 - patients with advanced breast cancer
Number of participants with treatment related. adverse events as assessed by CTCAE v5.0
Measured: through study completion,an average of 1 year
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Objective response rate (ORR)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with complete response (CR）
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with partial response (PR）
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with stable disease (SD)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with progressive disease (PD)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
duration of response (DoR)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
disease control rate (DCR)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
clinical benefit rate (CBR)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
time to progression (TTP)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
progression-free survival (PFS)
Measured: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
overall survival (OS)
Measured: through study completion，an average of 1 year.
Comparison of changes in maximum uptake ability of FES(progression free survival) in breast cancer lesions before and after treatment with LX-039 by PET(positron emission tomography) scan (performed in some subjects)
Decrease in SUVmax in comparison with that before treatment
Measured: Up to the third day of Cycle 2(each cycle is 28 days)
PK profiles after a single dose of LX-039
Peak Concentration (Cmax)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Peak Time (Tmax)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Elimination Half-life (t1/2)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Eliminate Rate Constant (Kel)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Mean Residence Time (MRT)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from 0 time to 24 hours (AUC0-24h)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from 0 time to sampling time t of the last measurable concentration (AUC0-last)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from administration (0) to infinity (AUC0-inf)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Apparent Total Clearance (CL/F)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Apparent Volume of Distribution (Vd/F)
Measured: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after continuous administration of LX-039
Trough Concentration at Steady State (Css, min)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Peak Concentration at Steady State (Css, max)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Average Concentration at Steady State (Css, av)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Peak Time (Tss, max)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Apparent Volume of Distribution at steady state (Vss/F)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Steady-state Clearance Half-life (tss,1/2)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Total Body Clearance (CLss/F)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Coefficient of Fluctuation (DF)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Area under Plasma Concentration-time Curve at Steady State (AUCss)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Accumulation Coefficient (Rac)
Measured: Up to the Second day of Cycle 2(each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 20207 Feb 2023

First posted20 Sep 2019
Study start7 Jan 2020
Primary completion8 Aug 2022
Study completion7 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Breast 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: Non-randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097756
Sponsor's protocol ID: OE861801
Status last verified: Oct 2020
First submitted: 29 Jul 2019
Last updated: 1 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lu J, Chan CC, Sun D, Hu G, He H, Li J, Dong J, Liu K, Shen L, Hu L, Gu Q, Chen S, Wang T, Gong T, Tang W, Li X, Zhu X, Zeng X, Zhu Y, Xia Y, Huang Y, Zhu Y, Liu Z, Ding CZ. Discovery and preclinical profile of LX-039, a novel indole-based oral selective estrogen receptor degrader (SERD). Bioorg Med Chem Lett. 2022 Jun 15;66:128734. doi: 10.1016/j.bmcl.2022.128734. Epub 2022 Apr 15.
PubMed 35436589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of LX-039 Tablets in Postmenopausal Patients With ER+, HER2- Advanced Breast Cancer After Failure of Endocrine Therapy
ClinicalTrials.gov ID: NCT04097756
Acronym / sponsor ID: OE861801
Conditions: Advanced Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Jan 2020 (actual)
Primary completion: 8 Aug 2022 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 20 Sep 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Part1：dose escalation	Experimental	Drug: LX-039 tabletsThe investigational product for this study is LX-039 tablets,which can be administered orally. 6~8 ascending dose level until MTD and the specification included 50 mg, 100 mg, 200 mg, 400 mg, 600 mg , 800 mg,1050 mg and 1400 mg. LX-039 tablets will be administered in a therapeutic cycle of 28 days once a day orally. The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2：dose expansion	Experimental	Drug: LX-039 tablets2~3 selected tolerable dose will be selected according to the tolerance and FES PET results of dose escalation phase.The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Be able to read and sign the informed consent form.
Adult females (aged ≥18 and ≤75 years).
Be diagnosed with breast cancer confirmed by pathological examination.
Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining).
Be postmenopausal.

Key exclusion criteria (16 listed)

Subjects with HER2-overexpressing breast cancer.
Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated.
Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications.
Subjects who received second-line or above chemotherapy.
Subjects with known allergy to this product or any of its components.

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
LX-039 tabletsorally once daily until disease progression, unacceptable toxicity, withdrawal of consent, or study termination	Drug	Part 2：dose expansion, Part1：dose escalation

Primary outcome

To explore the tolerance of LX-039 in ER +, HER2 - patients with advanced breast cancer
Time frame: DLT observation period(5 weeks for dose escalation, 4 weeks for dose expansion)
Incidence of dose limiting toxicities (DLTs)

33 secondary outcomes

The safety of LX-039 in ER +, HER2 - patients with advanced breast cancer
Time frame: through study completion,an average of 1 year
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Time frame: through study completion，an average of 1 year.
Comparison of changes in maximum uptake ability of FES(progression free survival) in breast cancer lesions before and after treatment with LX-039 by PET(positron emission tomography) scan (performed in some subjects)
Time frame: Up to the third day of Cycle 2(each cycle is 28 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Derived from this study: PubMed 35436589Lu J, Chan CC, Sun D, Hu G, He H, Li J, Dong J, Liu K, Shen L, Hu L, Gu Q, Chen S, Wang T, Gong T, Tang W, Li X, Zhu X, Zeng X, Zhu Y, Xia Y, Huang Y, Zhu Y, Liu Z, Ding CZ. Discovery and preclinical profile of LX-039, a novel indole-based oral selective estrogen receptor degrader (SERD). Bioorg Med Chem Lett. 2022 Jun 15;66:128734. doi: 10.1016/j.bmcl.2022.128734. Epub 2022 Apr 15.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LX-039 tablets in people with Advanced Breast Cancer, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

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 11 inclusion and 16 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: finished, as of the sponsor's last update on 1 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 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To explore the tolerance of LX-039 in ER +, HER2 - patients with advanced breast cancer (time frame: DLT observation period(5 weeks for dose escalation, 4 weeks for dose expansion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04097756, which also lists 1 linked publication.

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 1 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.