Testing HSK41959 in patients with advanced solid tumors and MTAP deletion

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 phase I study evaluates the safety and tolerability of HSK41959, an oral medication, in patients with locally advanced or metastatic solid tumors that have a homozygous deletion of the MTAP gene. The study consists of two phases: a dose escalation phase (Phase Ia) and a dose expansion phase (Phase Ib). In Phase Ia, a '3+3' design will be used to determine the maximum tolerated dose, while Phase Ib will further assess the drug's effects in larger patient cohorts. The study aims to enroll approximately 30-50 subjects in Phase Ia and 10-50 subjects in each expansion cohort of Phase Ib.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years，Male and female patients, at time of signing informed consent form (ICF).
2. ECOG performance status 0-1.
3. Life expectancy ≥ 3 months.
4. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment).
5. Homozygous deletion of the MTAP gene detected in tumor tissue confirmed prior to the administration of HSK41959.
6. Measurable disease by RECIST 1.1 criteria.
7. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
2. The presence of unstable, clinically symptomatic central nervous system metastases or leptomeningeal metastases.
3. Malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
4. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.

   Treatment with any of the following:
5. Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK41959, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK41959; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK41959; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK41959.
6. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.
7. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
8. Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)/470(female) msec; any clinically significant arrhythmia; left ventricular ejection fraction \< 50%; myocardial infarction, unstable angina, or class III/IV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK41959.
9. Any thromboembolic events within 6 months prior to the first dose of HSK41959; any familial or acquired thrombophilia.
10. Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol/L), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.
11. Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
12. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.
13. Other protocol-defined Inclusion/Exclusion criteria apply

Where it's running

• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• The Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• AK157D1 injection for advanced solid tumors

  A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• MK-2010 alone or with other treatments for advanced solid tumors

  This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

  Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

• Whole-Body Infrared Heating for Advanced Solid Tumors

  This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

  Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

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.