Test of HSK46256, a PARP1 inhibitor, in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multicenter Phase 1 trial of HSK46256 tablets. It uses a 3+3 dose-escalation design to identify safe dose levels and then expands respective cohorts to further assess safety and preliminary signs of efficacy. The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with HRR-mutant advanced solid tumors. Eligible patients have limited treatment options and may contribute tumor tissue or blood samples for correlative studies. The trial is led by Haisco Pharmaceutical with participation at Fudan University Shanghai Cancer Center in Shanghai, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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);
* 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;

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.