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Not yet recruiting NCT07695142

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor (Phase 1)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HSK46256.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor (Phase 1). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug HSK46256
    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.

Primary outcome measures

  • DLTs [Time frame: Up to 24 days]
  • MTD [Time frame: Up to 24 days]
Secondary outcome measures (8)
  • 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)]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07695142 · HSK46256-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗