mCRPCPhase 1NCT07897071
AXT-1003 Combination With Enzalutamide in Participants With mCRPC
A Phase 1 study testing AXT-1003, Enzalutamide in people with mCRPC, run by Axter Therapeutics (Beijing) Co., Ltd at 4 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy, and safety of AXT-1003 combined with Enzalutamide in subjects with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- mCRPC
- What is being tested?
- AXT-1003, Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesChina
- Study dates
- 24 Sep 2026to Dec 2029
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Histologically/cytologically confirmed prostate adenocarcinoma; neuroendocrine and small cell carcinoma excluded.
- Metastatic disease with evaluable bone lesions (per PCWG3) or measurable soft tissue lesions (per RECIST v1.1).
- Ongoing LHRH agonist/antagonist therapy, except prior bilateral orchiectomy.
- Serum testosterone at castration level (≤50 ng/dL or 1.7 nmol/L) at screening.
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- Documented disease progression at screening.
- Adequate organ function.
- Male subjects with childbearing potential partners must use effective contraception through 3 months after last dose.
Who cannot join
- Received chemotherapy, immunotherapy, definitive radiotherapy, major surgery, targeted therapy or other anti-tumor treatments within 4 weeks prior to first dose.
- Received palliative radiotherapy within 2 weeks prior to first dose.
- Received traditional Chinese medicine (TCM) therapy with anti-tumor indications within 2 weeks prior to first study treatment.
- Participated in any other clinical trial within 28 days prior to first study treatment.
- Active brain metastases or leptomeningeal metastases.
- History of stroke or other severe cerebrovascular disease within 12 months before enrollment.
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- Uncontrolled or significantly symptomatic cardiovascular disease.
- Known or suspected hypersensitivity to AXT-1003, any of its excipients, or any components of enzalutamide soft capsules.
- History of other prior malignancies, except for curatively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or other carcinoma in situ with no recurrence for 5 years after treatment.
- Clinically significant toxicities from any prior therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or other investigational treatment) unresolved to Grade ≤ 1 at enrollment, unless deemed no safety risk by the investigator.
- Active infection (requiring intravenous antibiotics or hospitalization), active autoimmune diseases and inflammatory diseases.
- Received live virus vaccines (including attenuated live vaccines) within 28 days prior to dosing.
- Active hepatitis B or hepatitis C infection.
- Known human immunodeficiency virus (HIV) infection and active tuberculosis.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wilson Wang, Head of Clinical Operation contact
China4 sites, 4 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Not yet recruiting
Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, 510062
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201315
About this study
Official title: An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AXT-1003 Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to evaluate the efficacy, and safety of AXT-1003 combined with Enzalutamide in subjects with advanced prostate cancer.
Read the detailed description
This study consists of two phases. The first phase (Phase Ia) is a safety lead-in study of AXT-1003 in combination with Enzalutamide; the second phase (Phase Ib) is a dose expansion study. Phase Ia is a non-randomized, open-label study designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AXT-1003 in combination therapy. Based on data derived from the Phase Ia dose-escalation phase, two dose levels of AXT-1003 will be selected for an expansion study in combination with enzalutamide, to explore the antitumor activity.
- Conditions
- mCRPC
- Being tested
- AXT-1003, Enzalutamide
- Keywords
- AXT-1003, EZH2, Enzalutamide, Phase I, Advanced malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXT-1003, EnzalutamideDrug
AXT-1003：Ascending oral doses from 10 mg to 40 mg BID, to determine MTD and RP2D.
Enzalutamide: Fixed dose of 160 mg QD orally, administered orally in combination.
AXT-1003, EnzalutamideDrug
Select 1 or 2 dose levels from dose escalation part. Enzalutamide: Fixed dose of 160 mg QD orally, administered orally in combination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Dose Escalation AXT-1003+Enzalutamide | Experimental | Dose Escalation AXT-1003+Enzalutamide Receives: Drug: AXT-1003, Enzalutamide |
| Experimental: Dose Expansion AXT-1003+Enzalutamide | Experimental | Experimental: Dose Expansion AXT-1003+Enzalutamide Receives: Drug: AXT-1003, Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT events
Incidence of dose-limiting toxicity (DLT) events during the dose escalation phase
Measured: Up to 28 days
Incidence and severity of AEs and serious AEs (SAEs)
AEs refer to any adverse medical events occurring in participants from the initiation of AXT-1003 and Enzalutamide administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after AXT-1003 and Enzalutamide administration in participants. Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [6.0]).
Measured: Up to 3 years
Secondary outcomes (9)
rPFS
Radiographic progression-free survival
Measured: 3-5 years
PSA
Prostate-specific antigen (PSA)-related endpoints:
Measured: 3-5 years
Objective response rate (ORR)
Measured: 3-5 years
Duration of response (DOR)
Measured: 3-5 years
Pharmacokinetic (PK) Parameters : Maximum Observed Plasma Concentration (Cmax)
Multiple dose PK will be calculated as data permits.
Measured: Up to 2 years
PK Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Multiple dose PK will be calculated as data permits.
Measured: Up to 2 years
PK Parameters: Minimum Observed Plasma Concentration (Cmin)
Multiple dose PK will be calculated as data permits.
Measured: Up to 2 years
PK Parameters: Area Under the Curve (AUC)
Multiple dose PK will be calculated as data permits.
Measured: Up to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Multiple dose PK will be calculated as data permits.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start24 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRPCStudies 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
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axter Therapeutics (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qian Gao, PhD, Study director, Axter Therapeutics (Beijing) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897071
- Sponsor's protocol ID
- AXT1003-1103
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AXT-1003 Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT07897071
- Acronym / sponsor ID
- AXT1003-1103
- Conditions
- mCRPC
- Keywords
- AXT-1003, EZH2, Enzalutamide, Phase I, Advanced malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Axter Therapeutics (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Oct 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.
The purpose of this study is to evaluate the efficacy, and safety of AXT-1003 combined with Enzalutamide in subjects with advanced prostate cancer.
Detailed description
This study consists of two phases. The first phase (Phase Ia) is a safety lead-in study of AXT-1003 in combination with Enzalutamide; the second phase (Phase Ib) is a dose expansion study. Phase Ia is a non-randomized, open-label study designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AXT-1003 in combination therapy. Based on data derived from the Phase Ia dose-escalation phase, two dose levels of AXT-1003 will be selected for an expansion study in combination with enzalutamide, to explore the antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Dose Escalation AXT-1003+Enzalutamide | Experimental | Drug: AXT-1003, EnzalutamideDose Escalation AXT-1003+Enzalutamide |
| Experimental: Dose Expansion AXT-1003+Enzalutamide | Experimental | Drug: AXT-1003, EnzalutamideExperimental: Dose Expansion AXT-1003+Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Histologically/cytologically confirmed prostate adenocarcinoma; neuroendocrine and small cell carcinoma excluded.
- Metastatic disease with evaluable bone lesions (per PCWG3) or measurable soft tissue lesions (per RECIST v1.1).
- Ongoing LHRH agonist/antagonist therapy, except prior bilateral orchiectomy.
Key exclusion criteria (14 listed)
- Received chemotherapy, immunotherapy, definitive radiotherapy, major surgery, targeted therapy or other anti-tumor treatments within 4 weeks prior to first dose.
- Received palliative radiotherapy within 2 weeks prior to first dose.
- Received traditional Chinese medicine (TCM) therapy with anti-tumor indications within 2 weeks prior to first study treatment.
- Participated in any other clinical trial within 28 days prior to first study treatment.
- Active brain metastases or leptomeningeal metastases.
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 |
|---|---|---|
| AXT-1003, EnzalutamideAXT-1003：Ascending oral doses from 10 mg to 40 mg BID, to determine MTD and RP2D. Enzalutamide: Fixed dose of 160 mg QD orally, administered orally in combination. | Drug | Experimental: Dose Escalation AXT-1003+Enzalutamide |
| AXT-1003, EnzalutamideSelect 1 or 2 dose levels from dose escalation part. Enzalutamide: Fixed dose of 160 mg QD orally, administered orally in combination. | Drug | Experimental: Dose Expansion AXT-1003+Enzalutamide |
Primary outcome
DLT events
Time frame: Up to 28 days
Incidence of dose-limiting toxicity (DLT) events during the dose escalation phase
Incidence and severity of AEs and serious AEs (SAEs)
Time frame: Up to 3 years
AEs refer to any adverse medical events occurring in participants from the initiation of AXT-1003 and Enzalutamide administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after AXT-1003 and Enzalutamide administration in participants. Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [6.0]).
9 secondary outcomes
rPFS
Time frame: 3-5 years
PSA
Time frame: 3-5 years
Objective response rate (ORR)
Time frame: 3-5 years
Duration of response (DOR)
Time frame: 3-5 years
Pharmacokinetic (PK) Parameters : Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 2 years
PK Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 2 years
PK Parameters: Minimum Observed Plasma Concentration (Cmin)
Time frame: Up to 2 years
PK Parameters: Area Under the Curve (AUC)
Time frame: Up to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Time frame: Up to 2 years
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 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for mCRPC
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
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.
Wilson Wang, Head of Clinical Operation contact
Qian Gao, PhD study director
Axter Therapeutics (Beijing) Co., Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AXT-1003, Enzalutamide in people with mCRPC, run by Axter Therapeutics (Beijing) Co., Ltd at 4 sites 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 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Sara Hua, APM (0086+15624980624, sara.hua@axtertx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT events (time frame: Up to 28 days). 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 27 Oct 2026.