Advanced Solid Tumor (Phase 1)Phase 1NCT07695142
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
A Phase 1 study testing HSK46256 in people with Advanced Solid Tumor (Phase 1), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase and a dose expansion phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor (Phase 1)
- What is being tested?
- HSK46256
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to 30 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, voluntarily participate and provide signed informed consent,
- ECOG performance status 0-1 or KPS >60; estimated life expectancy ≥12 weeks,
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors, failed prior standard therapy, intolerant to standard therapy, or no available standard therapy,
- Dose escalation: prior treatment with one line of non-selective PARP inhibitor allowed,
- Documented HRR gene mutation,
- Agree to provide tumor tissue and/or blood samples,
- Fertile participants must agree to use effective contraception during study and for 3 months after last dose; negative pregnancy test for females,
Who cannot join
- Other malignancies within past 2 years (except adequately treated basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma);
- Uncontrolled moderate to large pleural, pericardial, or peritoneal effusions;
- Prior anticancer therapy or concomitant use of CYP3A4 strong/moderate inhibitors/inducers within protocol-specified washout periods;
- Prior anticancer treatment toxicity not resolved to CTCAE ≤Grade 1 (except alopecia, skin toxicity);
- Any condition affecting drug swallowing or significantly impacting drug absorption/PK;
- Severe or uncontrolled cardiac disease (QTcF prolongation, significant arrhythmia, LVEF <50%, recent MI/heart failure);
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- Arterial/venous thromboembolic events within 6 months deemed uncontrolled risk;
- Severe/uncontrolled diabetes, hypertension, active bleeding, epilepsy, COPD, interstitial lung disease, active systemic infection;
- Unstable systemic disease (severe hepatic/renal/metabolic disorders);
- Prior MDS or AML diagnosis, or history of hematopoietic stem cell transplantation;
- Major surgery or severe trauma within 4 weeks;
- HIV positive, active hepatitis B/C, or active syphilis;
- Known hypersensitivity to study drug or excipients;
- Participation in another interventional trial within 4 weeks;
- Pregnant or lactating women;
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
Fudan University Shanghai Cancer Center
Shanghai
Jian Zhang, MD, +86 18017312991, syner2000@126.com
About this study
Official title: A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 Tablets in Patients With Advanced Solid Tumors
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase and a dose expansion phase. In the dose escalation phase, a 3+3 dose escalation design will be used to evaluate multiple dose levels. The dose expansion phase will enroll patients into expansion cohorts at selected dose levels to further evaluate safety and preliminary efficacy.
- Conditions
- Advanced Solid Tumor (Phase 1)
- Being tested
- HSK46256
- Keywords
- PARP inhibitor, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK46256Drug
Oral administration. Dose escalation: an initial single-dose period followed by multiple-dose cycles until disease progression or intolerable toxicity. Dose expansion: multiple-dose cycles directly. Specific dose levels and dosing frequency will be determined based on dose-escalation data.
| Study group | Role | What they receive |
|---|---|---|
| HSK46256 as monotherapy | Experimental | Drug: HSK46256 Administration: Oral tablet, once daily (except during the single-dose period) Regimen: Single-agent, dose-escalation Duration: Until disease progression or treatment discontinuation Receives: Drug: HSK46256 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle1
Measured: Up to 24 days
MTD
Maximum Tolerated Dose
Measured: Up to 24 days
Secondary outcomes (8)
Progression-Free Survival (PFS)
Measured: Up to 24 months
Duration of Response (DOR)
Measured: Up to 24 months
Disease Control Rate (DCR)
Measured: Up to 24 months
Radiographic Progression-Free Survival (rPFS, prostate cancer only)
Measured: Up to 24 months
Objective Response Rate (ORR)
Complete response + Partial response (CR+PR) based on RECIST 1.1.
Measured: Up to 24 months
PK parameters of HSK46256
Peak plasma concentration (Cmax)
Measured: Circle 1 (21 days)
Pharmacokinetic parameters of HSK46256
Area Under the Plasma Concentration-Time Curve (AUC)
Measured: Circle 1 (21 days)
Pharmacokinetic parameters of HSK46256
Half-life (T1/2)
Measured: Circle 1 (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start9 Jul 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor (Phase 1)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695142
- Sponsor's protocol ID
- HSK46256-101
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 Tablets in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07695142
- Acronym / sponsor ID
- HSK46256-101
- Conditions
- Advanced Solid Tumor (Phase 1)
- Keywords
- PARP inhibitor, advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 10 Jul 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.
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase and a dose expansion phase. In the dose escalation phase, a 3+3 dose escalation design will be used to evaluate multiple dose levels. The dose expansion phase will enroll patients into expansion cohorts at selected dose levels to further evaluate safety and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSK46256 as monotherapy | Experimental | Drug: HSK46256Drug: HSK46256 Administration: Oral tablet, once daily (except during the single-dose period) Regimen: Single-agent, dose-escalation Duration: Until disease progression or treatment discontinuation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years, voluntarily participate and provide signed informed consent,
- ECOG performance status 0-1 or KPS >60; estimated life expectancy ≥12 weeks,
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors, failed prior standard therapy, intolerant to standard therapy, or no available standard therapy,
- Dose escalation: prior treatment with one line of non-selective PARP inhibitor allowed,
- Documented HRR gene mutation,
Key exclusion criteria (15 listed)
- Other malignancies within past 2 years (except adequately treated basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma);
- Uncontrolled moderate to large pleural, pericardial, or peritoneal effusions;
- Prior anticancer therapy or concomitant use of CYP3A4 strong/moderate inhibitors/inducers within protocol-specified washout periods;
- Prior anticancer treatment toxicity not resolved to CTCAE ≤Grade 1 (except alopecia, skin toxicity);
- Any condition affecting drug swallowing or significantly impacting drug absorption/PK;
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 |
|---|---|---|
| HSK46256Oral administration. Dose escalation: an initial single-dose period followed by multiple-dose cycles until disease progression or intolerable toxicity. Dose expansion: multiple-dose cycles directly. Specific dose levels and dosing frequency will be determined based on dose-escalation data. | Drug | HSK46256 as monotherapy |
Primary outcome
DLTs
Time frame: Up to 24 days
Incidence of dose-limiting toxicities (DLTs) at Cycle1
MTD
Time frame: Up to 24 days
Maximum Tolerated Dose
8 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Radiographic Progression-Free Survival (rPFS, prostate cancer only)
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
PK parameters of HSK46256
Time frame: Circle 1 (21 days)
Pharmacokinetic parameters of HSK46256
Time frame: Circle 1 (21 days)
Pharmacokinetic parameters of HSK46256
Time frame: Circle 1 (21 days)
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 HSK46256 in people with Advanced Solid Tumor (Phase 1), run by Haisco 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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 10 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: Up to 24 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 10 Jul 2026.