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
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);
Show all 15Show fewer
- 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