Metastatic Castration-Resistant Prostate Cancer PatientsPhase 1NCT07514065
TSL2109 Capsules in Advanced Solid Tumor Patients: Safety, Tolerability, PK and Preliminary Efficacy
A Phase 1 study testing Treatment arm: TSL2109 capsules。Oral administration。 in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
TSL2109 is a novel CDK4/6-DYRK2 dual-target inhibitor developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd. for solid tumor treatment. Preclinical studies confirm its selective targeting of CDK4/6 and DYRK2, a eukaryotic CMGC family kinase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer Patients
- What is being tested?
- Treatment arm: TSL2109 capsules。Oral administration。
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years.
- Histologically or cytologically confirmed advanced solid tumors, with failure of prior standard therapy, or no available standard therapy, or currently unsuitable for standard therapy, and not amenable to surgery or radiotherapy with curative intent. Priority will be given to patients with metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
- (Dose-Escalation Phase) At least one evaluable or measurable tumor lesion per RECIST Version 1.1; (Dose-Expansion Phase) At least one measurable tumor lesion per RECIST Version 1.1 (tumor lesions located in prior radiation fields or other locally treated sites generally do not qualify as measurable lesions unless there is clear progression or persistence three months after radiotherapy).
- Life expectancy ≥3 months.
- ECOG performance status score of 0 to 1.
- Metastatic Castration-Resistant Prostate Cancer (mCRPC):
Show all 9Show fewer
- Castration status at screening: (1) Currently receiving androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or history of bilateral orchiectomy. (2) Serum total testosterone ≤1.7 nmol/L (50 ng/dL) at screening. Additionally, progression documented by one or more of the following three criteria: ① PSA progression defined as PSA >1 ng/mL with two consecutive increases >50% from baseline at least 1 week apart; ② Soft tissue disease progression per RECIST 1.1; ③ Bone disease progression per PCWG3, defined as two or more new bone lesions on bone scan. Priority will be given to end-line patients who have received prior androgen receptor inhibitors and have received chemotherapy or are chemotherapy-intolerant or chemotherapy-refusing.
- HR+/HER2- Breast Cancer:
- ① Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer (determined from the most recent tumor sample [primary or metastatic] with histological confirmation of HR+/HER2- status. To meet HR+ disease requirements, breast cancer must express estrogen receptor [ER], with or without progesterone receptor co-expression), locally advanced or recurrent/metastatic breast cancer in female patients. ② Prior exposure to CDK4/6 inhibitors (e.g., abemaciclib, palbociclib, etc.).
Who cannot join
- Clinically symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or other evidence indicating uncontrolled CNS or leptomeningeal metastases, judged by the investigator as unsuitable for enrollment.
- Diagnosis of another invasive malignancy within the past 2 years, except for radically treated non-melanomatous skin cancer or superficial urothelial carcinoma, cutaneous basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, such as inability to take oral medications, uncontrolled nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, untreated gastric conditions requiring long-term proton pump inhibitor therapy, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.
- Imaging (CT or MRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries/veins, vena cava, etc.) with assessed bleeding risk.
- Interstitial lung disease, pneumonitis, or pulmonary fibrosis, assessed by the investigator as unsuitable for enrollment.
- History of deep vein thromboembolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Gaobo Cancer Hospital (China Pharmaceutical University)
Shanghai, Shanghai Municipality, 200003
Jin Li, Doctor, 00-86-021-60571205, lijin@csco.org.cn
About this study
Official title: Multicenter, Dose-Escalation & Dose-Expansion, Single-Arm, Open-Label Phase I Trial: Safety, Tolerability, PK and Preliminary Antitumor Efficacy of TSL2109 Capsules in Advanced Solid Tumor Patients
TSL2109 is a novel CDK4/6-DYRK2 dual-target inhibitor developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd. for solid tumor treatment. Preclinical studies confirm its selective targeting of CDK4/6 and DYRK2, a eukaryotic CMGC family kinase.
In palbociclib-resistant cell lines, TSL2109 downregulates cell cycle-related proteins and DYRK2 pathway ribosomal synthesis regulators (RRS1, CDK2), and upregulates p53, thus exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.
Read more
As a small-molecule inhibitor with novel targets, structure and mechanism, TSL2109 blocks tumor cell cycle progression independently of hormonal signaling. Preclinical studies show it overcomes AR inhibitor resistance, meeting unmet needs for prostate cancer patients progressing after AR inhibitor therapy. It also reduces CDK2 activity and blocks CDK4/6 compensatory mechanisms, reversing resistance to CDK4/6 inhibitors, providing a new option for HR+/HER2- advanced breast cancer patients.
Participants Dose-Escalation Phase: Advanced solid tumor patients, prioritizing metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
Dose-Expansion Phase:
Cohort A/C: mCRPC; Cohort B/D: HR+/HER2- advanced breast cancer. Treatment Regimens C0 Cycle (3 days): Single oral dose on Day 1 morning under fasting, followed by 72-hour observation.
C1 Cycle (28 days): Daily fasting oral dosing (QD) for 3 weeks, then 1-week rest. Participants may continue treatment if no DLT and potential clinical benefit.
Dose escalation to a pre-established tolerable level is allowed per investigator-sponsor agreement if well-tolerated and likely beneficial. Treatment continues until disease progression, intolerable toxicity or new antitumor therapy. The Dose-Expansion Phase uses the same regimen as C1.
Missed Dose: Make-up within 8 hours; skip if delayed over 8 hours. Notes: Once MTD is determined, participants dosed above MTD will be adjusted to MTD. All doses are administered orally under fasting conditions.
Read the detailed description
TSL2109 is a novel dual-target inhibitor of Cyclin-Dependent Kinase 4/6-Dualspecificity tyrosine-(Y)-phosphorylation Regulated Kinase 2 (CDK4/6-DYRK2) developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd., intended for the treatment of solid tumors. Preclinical studies have demonstrated that TSL2109 selectively targets CDK4/6 and DYRK2, where DYRK2 (Dual-specificity tyrosine-phosphorylation regulated kinase 2) belongs to the CMGC family of the eukaryotic kinome. In vitro treatment of palbociclib-resistant cell lines with TSL2109 induced downregulation of cell cycle-related proteins and downstream ribosomal synthesis regulatory proteins of the DYRK2 signaling pathway, including Regulator of Ribosome Synthesis 1 (RRS1) and Recombinant Cyclin-Dependent Kinase 2 (CDK2), while simultaneously upregulating Recombinant Tumor Protein P53 (p53), thereby exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.This product is a selective small-molecule inhibitor of DYRK2 and CDK4/6 based on novel anticancer targets, novel chemical structure, and novel mechanism of action.
Selective inhibition of DYRK2 and CDK4/6 can block tumor cell cycle progression independent of hormonal signaling pathways. In vitro and in vivo animal experiments have demonstrated promising efficacy in overcoming resistance to androgen receptor (AR) inhibitors, addressing the unmet clinical need for prostate cancer patients who have progressed following AR inhibitor therapy. Secondly, selective inhibition of DYRK2 can reduce CDK2 activity and block CDK4/6 compensatory mechanisms, with in vitro and in vivo animal experiments showing efficacy in overcoming resistance to CDK4/6 inhibitors. This addresses the treatment challenge for patients with HR+/HER2- advanced breast cancer who have progressed following CDK4/6 inhibitor therapy, providing a novel therapeutic option for HR+/HER2- breast cancer patients.
Participants:
Dose-Escalation Phase: Patients with advanced solid tumors, with priority given to those with metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
Dose-Expansion Phase:
Cohort A and/or Cohort C: Metastatic castration-resistant prostate cancer (mCRPC) Cohort B and/or Cohort D: HR+/HER2- advanced breast cancer C0 Treatment Cycle (3 days): Oral administration on the morning of Day 1 under fasting conditions, followed by 72-hour observation.
C1 Treatment Cycle (28 days): Multiple doses administered under fasting conditions, with daily dosing (QD) for 3 weeks followed by a 1-week treatment-free interval. If no dose-limiting toxicity (DLT) occurs during the DLT observation period and the investigator determines that continued treatment may provide benefit, the participant may continue receiving study treatment.
During subsequent treatment, if the investigator determines based on available safety and efficacy data that increasing the dose may enhance potential benefit for the participant, and the participant has demonstrated good tolerability, the dose level may be escalated to a previously established tolerable dose following discussion between the investigator and sponsor. Treatment may continue until disease progression, intolerable toxicity, or initiation of new antitumor therapy.
Dose-Expansion Phase: The same dosing regimen as C1. Missed Dose: Make-up dosing is permitted within 8 hours; if more than 8 hours have elapsed, the missed dose should be skipped.
Notes:
Participants previously enrolled at dose levels above the maximum tolerated dose (MTD) will have their subsequent doses adjusted to the MTD dose level once the MTD is established.
Administered orally under fasting conditions.
- Being tested
- Treatment arm: TSL2109 capsules。Oral administration。
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment arm: TSL2109 capsules。Oral administration。Drug
Also called DYRK2-CDK4/6
Dosage and Administration: Oral administration on an empty stomach, once daily. Applicable to 50mg (2 capsules of 25mg), 100mg (1 capsule of 100mg), 200mg (2 capsules of 100mg), 300mg (3 capsules of 100mg), 400mg (4 capsules of 100mg), and 500mg (5 capsules of 100mg) dose groups.
Duration of Treatment: Multiple dosing, with each treatment cycle consisting of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm/Group: TSL2109 capsules | Experimental | Dose Group 1: 50mg, 1 subject Dose 2: 100mg, 1 subject Dose 3: 200mg, 3-9 subjects Dose 4: 300mg, 3-9 subjects Dose 5: 400mg, 3-9 subjects Dose 6: 500mg, 3-9 subjects Receives: Drug: Treatment arm: TSL2109 capsules。Oral administration。 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability assessment
determine the dose-limiting toxicity (DLT)
Measured: Within 31 days after dosing
Tolerability assessment
maximum tolerated dose (MTD) (if obtainable)
Measured: Within 31 days after dosing
Tolerability assessment
the recommended Phase II dose (RP2D)
Measured: Within 31 days after dosing
Secondary outcomes (3)
Drug concentration of 2109 in participant blood
Cmax
Measured: Within 31 days after dosing
Drug concentration of 2109 in participant blood
Tmax
Measured: Within 31 days after dosing
Drug concentration of 2109 in participant blood
t1/2
Measured: Within 31 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start20 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Doctor, Principal investigator, Shanghai Gobroad Cancer Hospital (China Pharmaceutical University)Shu K Qin, Doctor, Study chair, Nanjing Tianyinshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514065
- Sponsor's protocol ID
- TSL-CM-2109-I
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect patient privacy, uphold informed consent, and comply with applicable data protection regulations and ethical research standards.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Dose-Escalation & Dose-Expansion, Single-Arm, Open-Label Phase I Trial: Safety, Tolerability, PK and Preliminary Antitumor Efficacy of TSL2109 Capsules in Advanced Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT07514065
- Acronym / sponsor ID
- TSL-CM-2109-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
TSL2109 is a novel CDK4/6-DYRK2 dual-target inhibitor developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd. for solid tumor treatment. Preclinical studies confirm its selective targeting of CDK4/6 and DYRK2, a eukaryotic CMGC family kinase.
In palbociclib-resistant cell lines, TSL2109 downregulates cell cycle-related proteins and DYRK2 pathway ribosomal synthesis regulators (RRS1, CDK2), and upregulates p53, thus exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.
As a small-molecule inhibitor with novel targets, structure and mechanism, TSL2109 blocks tumor cell cycle progression independently of hormonal signaling. Preclinical studies show it overcomes AR inhibitor resistance, meeting unmet needs for prostate cancer patients progressing after AR inhibitor therapy. It also reduces CDK2 activity and blocks CDK4/6 compensatory mechanisms, reversing resistance to CDK4/6 inhibitors, providing a new option for HR+/HER2- advanced breast cancer patients.
Participants Dose-Escalation Phase: Advanced solid tumor patients, prioritizing metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
Dose-Expansion Phase:
Cohort A/C: mCRPC; Cohort B/D: HR+/HER2- advanced breast cancer. Treatment Regimens C0 Cycle (3 days): Single oral dose on Day 1 morning under fasting, followed by 72-hour observation.
C1 Cycle (28 days): Daily fasting oral dosing (QD) for 3 weeks, then 1-week rest. Participants may continue treatment if no DLT and potential clinical benefit.
Dose escalation to a pre-established tolerable level is allowed per investigator-sponsor agreement if well-tolerated and likely beneficial. Treatment continues until disease progression, intolerable toxicity or new antitumor therapy. The Dose-Expansion Phase uses the same regimen as C1.
Missed Dose: Make-up within 8 hours; skip if delayed over 8 hours. Notes: Once MTD is determined, participants dosed above MTD will be adjusted to MTD. All doses are administered orally under fasting conditions.
Detailed description
TSL2109 is a novel dual-target inhibitor of Cyclin-Dependent Kinase 4/6-Dualspecificity tyrosine-(Y)-phosphorylation Regulated Kinase 2 (CDK4/6-DYRK2) developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd., intended for the treatment of solid tumors. Preclinical studies have demonstrated that TSL2109 selectively targets CDK4/6 and DYRK2, where DYRK2 (Dual-specificity tyrosine-phosphorylation regulated kinase 2) belongs to the CMGC family of the eukaryotic kinome. In vitro treatment of palbociclib-resistant cell lines with TSL2109 induced downregulation of cell cycle-related proteins and downstream ribosomal synthesis regulatory proteins of the DYRK2 signaling pathway, including Regulator of Ribosome Synthesis 1 (RRS1) and Recombinant Cyclin-Dependent Kinase 2 (CDK2), while simultaneously upregulating Recombinant Tumor Protein P53 (p53), thereby exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.This product is a selective small-molecule inhibitor of DYRK2 and CDK4/6 based on novel anticancer targets, novel chemical structure, and novel mechanism of action.
Selective inhibition of DYRK2 and CDK4/6 can block tumor cell cycle progression independent of hormonal signaling pathways. In vitro and in vivo animal experiments have demonstrated promising efficacy in overcoming resistance to androgen receptor (AR) inhibitors, addressing the unmet clinical need for prostate cancer patients who have progressed following AR inhibitor therapy. Secondly, selective inhibition of DYRK2 can reduce CDK2 activity and block CDK4/6 compensatory mechanisms, with in vitro and in vivo animal experiments showing efficacy in overcoming resistance to CDK4/6 inhibitors. This addresses the treatment challenge for patients with HR+/HER2- advanced breast cancer who have progressed following CDK4/6 inhibitor therapy, providing a novel therapeutic option for HR+/HER2- breast cancer patients.
Participants:
Dose-Escalation Phase: Patients with advanced solid tumors, with priority given to those with metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
Dose-Expansion Phase:
Cohort A and/or Cohort C: Metastatic castration-resistant prostate cancer (mCRPC) Cohort B and/or Cohort D: HR+/HER2- advanced breast cancer C0 Treatment Cycle (3 days): Oral administration on the morning of Day 1 under fasting conditions, followed by 72-hour observation.
C1 Treatment Cycle (28 days): Multiple doses administered under fasting conditions, with daily dosing (QD) for 3 weeks followed by a 1-week treatment-free interval. If no dose-limiting toxicity (DLT) occurs during the DLT observation period and the investigator determines that continued treatment may provide benefit, the participant may continue receiving study treatment.
During subsequent treatment, if the investigator determines based on available safety and efficacy data that increasing the dose may enhance potential benefit for the participant, and the participant has demonstrated good tolerability, the dose level may be escalated to a previously established tolerable dose following discussion between the investigator and sponsor. Treatment may continue until disease progression, intolerable toxicity, or initiation of new antitumor therapy.
Dose-Expansion Phase: The same dosing regimen as C1. Missed Dose: Make-up dosing is permitted within 8 hours; if more than 8 hours have elapsed, the missed dose should be skipped.
Notes:
Participants previously enrolled at dose levels above the maximum tolerated dose (MTD) will have their subsequent doses adjusted to the MTD dose level once the MTD is established.
Administered orally under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm/Group: TSL2109 capsules | Experimental | Drug: Treatment arm: TSL2109 capsules。Oral administration。Dose Group 1: 50mg, 1 subject Dose 2: 100mg, 1 subject Dose 3: 200mg, 3-9 subjects Dose 4: 300mg, 3-9 subjects Dose 5: 400mg, 3-9 subjects Dose 6: 500mg, 3-9 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed advanced solid tumors, with failure of prior standard therapy, or no available standard therapy, or currently unsuitable for standard therapy, and not amenable to surgery or radiotherapy with curative intent. Priority will be given to patients with metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer.
- (Dose-Escalation Phase) At least one evaluable or measurable tumor lesion per RECIST Version 1.1; (Dose-Expansion Phase) At least one measurable tumor lesion per RECIST Version 1.1 (tumor lesions located in prior radiation fields or other locally treated sites generally do not qualify as measurable lesions unless there is clear progression or persistence three months after radiotherapy).
- Life expectancy ≥3 months.
- ECOG performance status score of 0 to 1.
Key exclusion criteria (6 listed)
- Clinically symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or other evidence indicating uncontrolled CNS or leptomeningeal metastases, judged by the investigator as unsuitable for enrollment.
- Diagnosis of another invasive malignancy within the past 2 years, except for radically treated non-melanomatous skin cancer or superficial urothelial carcinoma, cutaneous basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, such as inability to take oral medications, uncontrolled nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, untreated gastric conditions requiring long-term proton pump inhibitor therapy, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.
- Imaging (CT or MRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries/veins, vena cava, etc.) with assessed bleeding risk.
- Interstitial lung disease, pneumonitis, or pulmonary fibrosis, assessed by the investigator as unsuitable for enrollment.
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 |
|---|---|---|
| Treatment arm: TSL2109 capsules。Oral administration。Also: DYRK2-CDK4/6Dosage and Administration: Oral administration on an empty stomach, once daily. Applicable to 50mg (2 capsules of 25mg), 100mg (1 capsule of 100mg), 200mg (2 capsules of 100mg), 300mg (3 capsules of 100mg), 400mg (4 capsules of 100mg), and 500mg (5 capsules of 100mg) dose groups. Duration of Treatment: Multiple dosing, with each treatment cycle consisting of 28 days. | Drug | Experimental arm/Group: TSL2109 capsules |
Primary outcome
Tolerability assessment
Time frame: Within 31 days after dosing
determine the dose-limiting toxicity (DLT)
Tolerability assessment
Time frame: Within 31 days after dosing
maximum tolerated dose (MTD) (if obtainable)
Tolerability assessment
Time frame: Within 31 days after dosing
the recommended Phase II dose (RP2D)
3 secondary outcomes
Drug concentration of 2109 in participant blood
Time frame: Within 31 days after dosing
Drug concentration of 2109 in participant blood
Time frame: Within 31 days after dosing
Drug concentration of 2109 in participant blood
Time frame: Within 31 days after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect patient privacy, uphold informed consent, and comply with applicable data protection regulations and ethical research standards.
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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.
Jin Li, Doctor principal investigator
Shanghai Gobroad Cancer Hospital (China Pharmaceutical University)
Shu K Qin, Doctor study chair
Nanjing Tianyinshan Hospital
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 Treatment arm: TSL2109 capsules。Oral administration。 in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Tasly Pharmaceutical Group 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (00-86-022-86343626, liurui383@taslypharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability assessment (time frame: Within 31 days after dosing). The study lists 3 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 Apr 2026.