Breast CancerPhase 1NCT04433494
A Study of TY-302 in Patients With Advanced Solid Tumors
A Phase 1 study testing TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg in people with Breast Cancer and Solid Tumor, run by TYK Medicines, Inc at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are: TY-302 Tamoxifen Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Solid Tumor
- What is being tested?
- TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2020to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70years old, male or female with solid tumors, female with breast cancer
- Histological or cytological confirmation diagnosis of advanced solid tumors (except small cell lung cancer and eye cancer) in TY-302 alone study; and advanced breast cancer in the combination study.
- Biopsy proven diagnosis of ER and/or PR positive, HER2 negative.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Life expectancy of at least 3 month.
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- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin ≤1.5 x ULN; Absolute neutrophil count (ANC) ≥1.5×109/L; platelets(PLT)≥75×109/L ; Hemoglobin(Hb) ≥ 90g/L; Serum creatinine ≤1.5 x ULN; Left ejection fraction (LVEF)≥50%; QTc≤470 msec (based on the mean value of the triplicate ECGs).
- Female subjects have a negative urine or serum pregnancy.
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
Who cannot join
- Subjects presenting with any of the following were not to be included in the study:
- Previously treated by other CDK4/6 inhibitor.
- Hypersensitivity to TY-302(or Tamoxifen in the combination study) or to any of its excipients.
- Ocular fundus diseases in the combination study.
- Uncontrolled intercurrent illness including active infection, human immunodeficiency virus infection, active hepatitis or other severe acute or chronic medical or psychiatric condition.
- Current alcohol/drug abuse or dependence.
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- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure of NCI CTCAE grade≥2, cerebrovascular accident.
- Presence of a condition that would interfere with enteric absorption of TY-302 and/or Tamoxifen.
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs for the treatment from a previous treatment regimen within 4 weeks of the first dose.
- Spinal cord compression or brain metastases unless asymptomatic.
- Major surgery within 8 weeks of first study treatment.
- Current use or anticipated need for drugs that are known strong CYP3A4 inhibitors, strong CYP3A4 inducers, Narrow therapeutic index for CYP3A sensitive substrates, CYP2D6 inhibitors, CYP2D6 inducers.
- Patients on chronic anticoagulation.
- The subject inappropriate for entry into this study in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences and Peking Union Medical Colledge
Beijing, Beijing Municipality, 100021
Fei Ma, +86 13910217780, maifei2011@139.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of TY-302 Capsules in Patients With Advanced Solid Tumors in China
The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are:
- TY-302
- Tamoxifen
Read the detailed description
This is an open-label, single-arm, phase I trial. The purpose of this study is to :
- Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen
- Determine the response rate of the combination
- Further evaluate the safety and side effect profile for the combination of TY-302 and Tamoxifen.
- Conditions
- Breast Cancer, Solid Tumor
- Being tested
- TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mgDrug
Also called TY-302, Tamoxifen Citrate
TY-302 is taken orally. Tamoxifen is taken orally.
| Study group | Role | What they receive |
|---|---|---|
| TY-302 ; TY-302 combine with Tamoxifen | Experimental | 1. TY-302
* Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TY-302, given orally.
* Increased dose cohorts from low dose to MTD, starting at 25mg daily.
2. TY-302 combine withTamoxifen in dose-escalation stage
* TY-302: RP2D-1to RP2D daily for 28 days of each 28 day cycle.
* Tamoxifen: 20mg twice daily for 28 days of each 28 day cycle.
3. TY-302 combine withTamoxifen in dose-expansion stage
* TY-302: RP2D daily for 28 days of each 28 day cycle.
* Tamoxifen: 20mg twice daily for 28 days of each 28 day cycle. Receives: Drug: TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302
To determine the MTD and RP2D of TY-302 in subjects with solid tumors
Measured: 1 year
Dose Limiting Toxicity (DLT) of TY-302
Incidence of Dose Limiting Toxicity (DLT) of TY-302
Measured: First 35 days of dosing
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302 combine with Tamoxifen
To determine the MTD and RP2D of TY-302 and Tamoxifen on the combination in subjects with breast cancer
Measured: 1 year
Dose Limiting Toxicity (DLT) of TY-302 combine with Tamoxifen
Incidence of Dose Limiting Toxicity (DLT) of TY-302 and Tamoxifen on the combination
Measured: First 28 days of dosing
Overall Response Rate (ORR) of TY-302 combine with Tamoxifen
To assess the effect of TY-302 combine with Tamoxifen on ORR( the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) ) in the treatment of ER+/HER2- advanced breast cancer.
Measured: 6 months
Disease Control Rate(DCR) of TY-302 combine with Tamoxifen
To assess the effect of TY-302 combine with Tamoxifen on DCR(the proportion of patients with CR, PR, or stable disease(SD) assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Measured: 9 months
Duration of Response (DOR) of TY-302 combine with Tamoxifen
To assess the effect of TY-302 combine with Tamoxifen on DOR( the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Measured: 9 months
Progression-free Survival (PFS) of TY-302 combine with Tamoxifen
To assess the effect of TY-302 combine with Tamoxifen on PFS(time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start7 Dec 2020
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, MD, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical Colledge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433494
- Sponsor's protocol ID
- TYKM1602101
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of TY-302 Capsules in Patients With Advanced Solid Tumors in China
- ClinicalTrials.gov ID
- NCT04433494
- Acronym / sponsor ID
- TYKM1602101
- Conditions
- Breast Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jun 2020 (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.
The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are:
- TY-302
- Tamoxifen
Detailed description
This is an open-label, single-arm, phase I trial. The purpose of this study is to :
- Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen
- Determine the response rate of the combination
- Further evaluate the safety and side effect profile for the combination of TY-302 and Tamoxifen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TY-302 ; TY-302 combine with Tamoxifen | Experimental | Drug: TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg1. TY-302 * Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TY-302, given orally. * Increased dose cohorts from low dose to MTD, starting at 25mg daily. 2. TY-302 combine withTamoxifen in dose-escalation stage * TY-302: RP2D-1to RP2D daily for 28 days of each 28 day cycle. * Tamoxifen: 20mg twice daily for 28 days of each 28 day cycle. 3. TY-302 combine withTamoxifen in dose-expansion stage * TY-302: RP2D daily for 28 days of each 28 day cycle. * Tamoxifen: 20mg twice daily for 28 days of each 28 day cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-70years old, male or female with solid tumors, female with breast cancer
- Histological or cytological confirmation diagnosis of advanced solid tumors (except small cell lung cancer and eye cancer) in TY-302 alone study; and advanced breast cancer in the combination study.
- Biopsy proven diagnosis of ER and/or PR positive, HER2 negative.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Key exclusion criteria (14 listed)
- Previously treated by other CDK4/6 inhibitor.
- Hypersensitivity to TY-302(or Tamoxifen in the combination study) or to any of its excipients.
- Ocular fundus diseases in the combination study.
- Uncontrolled intercurrent illness including active infection, human immunodeficiency virus infection, active hepatitis or other severe acute or chronic medical or psychiatric condition.
- Current alcohol/drug abuse or dependence.
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 |
|---|---|---|
| TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mgAlso: TY-302, Tamoxifen CitrateTY-302 is taken orally. Tamoxifen is taken orally. | Drug | TY-302 ; TY-302 combine with Tamoxifen |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302
Time frame: 1 year
To determine the MTD and RP2D of TY-302 in subjects with solid tumors
Dose Limiting Toxicity (DLT) of TY-302
Time frame: First 35 days of dosing
Incidence of Dose Limiting Toxicity (DLT) of TY-302
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302 combine with Tamoxifen
Time frame: 1 year
To determine the MTD and RP2D of TY-302 and Tamoxifen on the combination in subjects with breast cancer
Dose Limiting Toxicity (DLT) of TY-302 combine with Tamoxifen
Time frame: First 28 days of dosing
Incidence of Dose Limiting Toxicity (DLT) of TY-302 and Tamoxifen on the combination
Overall Response Rate (ORR) of TY-302 combine with Tamoxifen
Time frame: 6 months
To assess the effect of TY-302 combine with Tamoxifen on ORR( the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) ) in the treatment of ER+/HER2- advanced breast cancer.
Disease Control Rate(DCR) of TY-302 combine with Tamoxifen
Time frame: 9 months
To assess the effect of TY-302 combine with Tamoxifen on DCR(the proportion of patients with CR, PR, or stable disease(SD) assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Duration of Response (DOR) of TY-302 combine with Tamoxifen
Time frame: 9 months
To assess the effect of TY-302 combine with Tamoxifen on DOR( the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Progression-free Survival (PFS) of TY-302 combine with Tamoxifen
Time frame: 12 months
To assess the effect of TY-302 combine with Tamoxifen on PFS(time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1) in the treatment of ER+/HER2- advanced breast cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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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.
Binghe Xu, MD principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical Colledge
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 TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg in people with Breast Cancer and Solid Tumor, run by TYK Medicines, Inc 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Ma, MD (+86 13910217780, maifei2011@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302 (time frame: 1 year). The study lists 8 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 7 Dec 2022.