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Advanced Solid TumorsPhase 1NCT06968572

Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion

A Phase 1 study testing HSK41959 in people with Advanced Solid Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK41959 when given orally in patients with MTAP Deletion locally advanced or metastatic Solid Tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HSK41959
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
3 sitesChina
Study dates
11 Apr 2025to 8 May 2028
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，Male and female patients, at time of signing informed consent form (ICF).
  • ECOG performance status 0-1.
  • Life expectancy ≥ 3 months.
  • 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).
  • Homozygous deletion of the MTAP gene detected in tumor tissue confirmed prior to the administration of HSK41959.
  • Measurable disease by RECIST 1.1 criteria.
  • Adequate hematologic, hepatic, and renal function.

Who cannot join

  • Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
  • The presence of unstable, clinically symptomatic central nervous system metastases or leptomeningeal metastases.
  • 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.
  • Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
  • Treatment with any of the following:
  • 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.
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  • 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.
  • Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
  • 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.
  • Any thromboembolic events within 6 months prior to the first dose of HSK41959; any familial or acquired thrombophilia.
  • 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.
  • Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
  • Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.
  • Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites, 3 recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Chao Yu, 86-13765021698, yuxchao2002@163.com

    Chao Yu

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Yongsheng Wang, 86-15150580136, dolphin8012@yahoo.com

    Yongsheng Wang

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Caicun Zhou, 86-13301825532, caicunzhoudr@163.com

    Caicun Zhou

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK41959 in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK41959 when given orally in patients with MTAP Deletion locally advanced or metastatic Solid Tumors.

Read the detailed description

The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.

Phase Ia will contain two part: Dose Escalation Part (Part A) and Extension Part (Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK41959. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-50 subjects will be enrolled in Phase Ia.

Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort.

Being tested
HSK41959

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK41959Drug

    Oral administration, QD

Study groups in NCT06968572
Study groupRoleWhat they receive
Phase Ia (Part A): HSK41959 as monotherapyExperimentalPhase 1a (Part A): dose escalation of HSK41959 as monotherapy at various dose levels
Receives: Drug: HSK41959
Phase Ia (Part B): HSK41959 as monotherapyExperimentalPhase 1a (Part B): dose extention of HSK41959 as monotherapy at certain dose levels
Receives: Drug: HSK41959
Phase Ib: HSK41959 as monotherapyExperimentalPhase 1b: dose expansion for HSK41959 as monotherapy at a dose determined during Phase 1a (Part B) in patients with MTAP Deletion locally advanced or metastatic solid tumors
Receives: Drug: HSK41959

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLTs

    Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1

    Measured: 24 days

  2. MTD

    MTD determination: dose limiting toxicity (DLT) rate

    Measured: 24 days

  3. AEs

    Rate and severity of adverse events of HSK41959 as monotherapy

    Measured: Up to approximately 3 years

  4. RP2D

    RP2D determination: DLT, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary safety and anticancer activity data

    Measured: Up to approximately 1 year

Secondary outcomes (9)

  1. Overall response rate (ORR)

    ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1

    Measured: Up to approximately 3 years

  2. Disease control rate (DCR)

    DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1

    Measured: Up to approximately 3 years

  3. Duration of response (DOR)

    DOR, defined as the time from first documented response of complete response (CR) or partial response (PR) to the date of first documented progressive disease or death due to any cause, whichever occurs first

    Measured: Up to approximately 3 years

  4. Progression free survival (PFS)

    PFS, defined as the time frocease or death due to any cause, whichever occurs first

    Measured: Up to approximately 3 years

  5. Overall survival (OS)

    OS, defined as the time from the first dose of HSK41959 until the date of death due to any cause

    Measured: Up to approximately 3 years

  6. Area under the curve (AUC) of HSK41959

    Measured: Up to approximately 6 months

  7. maximum plasma concentration (Cmax) of HSK41959

    Measured: Up to approximately 6 months

  8. half-life (t1/2) of HSK41959

    Measured: Up to approximately 6 months

  9. Tmax(Time to maximum plasma concentration) of HSK41959

    Measured: Up to approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start11 Apr 2025
  3. Primary completion26 Mar 2026 (estimated)
  4. Study completion8 May 2028 (estimated)

Resources

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
245 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06968572
Sponsor's protocol ID
HSK41959-101
Status last verified
May 2025
First submitted
9 Apr 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK41959 in people with Advanced Solid Tumors, run by Haisco Pharmaceutical Group Co., Ltd. at 3 sites 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 14 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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: 24 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06968572.

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 13 May 2025.

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