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Pancreatic AdenocarcinomaPhase 1NCT07583771

A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma

A Phase 1 study testing CS08399 in people with Pancreatic Adenocarcinoma and Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CS08399
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteChina
Study dates
Jun 2026to Jan 2030
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

  • Understand and sign the informed consent form voluntarily.
  • ≥18 years old when signing the informed consent, regardless of sex.
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed/refractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.
  • For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.
  • For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥3 months.
  • Able to swallow and retain oral study medication.

Who cannot join

  • Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).
  • Previously received MAT2A or PRMT5 inhibitors.
  • Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.
  • Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.
  • History of other primary malignancies within 5 years prior to the first dose.
  • For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.
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  • Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.
  • Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.
  • Active infection requiring systemic anti-infective treatment at screening.
  • Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.
  • Uncontrolled or significant cardiovascular disease.
  • Poorly controlled diabetes.
  • Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.
  • History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.
  • Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.
  • Serious thromboembolic events within 6 months prior to the first dose.
  • Active tuberculosis at screening.
  • Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.
  • Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.
  • History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • History of alcohol abuse or drug abuse.
  • Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.
  • Pregnant or breastfeeding women.
  • Other conditions deemed unsuitable for participation in this trial by the investigator.

Trial locations and contacts

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

Xuelian Zhou contact

028-64907337

zhouxuelian@chipscreen.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

    Xianjun Yu, 021-64175590, yuxianjun@fudanpci.org

Other trials in China

About this study

Official title: A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma

This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).

Being tested
CS08399
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • CS08399Drug

    Oral tablet. Only one dose on C0D1 in single-dose period. Once or twice daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases.

Study groups in NCT07583771
Study groupRoleWhat they receive
CS08399Experimentaltwo phases: dose escalation and cohort expansion. The dose escalation part is further divided into single-dose and multiple-dose administration. In the cohort expansion part, only multiple doses.
Receives: Drug: CS08399

What is being measured

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

  1. incidence of dose-limiting toxicity (DLT)

    Measured: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose

  2. maximum tolerated dose (MTD)

    Measured: dose escalation part, up to approximately 2 year

  3. incidence of adverse events (AEs)

    Number of participants with AE(s)

    Measured: from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first

  4. Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)

    Measured: during treatment, up to approximately 2 year

  5. Pharmacokinetic parameters: Maximum Concentration (Cmax)

    Measured: during treatment, up to approximately 2 year

  6. Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC)

    Measured: during treatment, up to approximately 2 year

  7. Pharmacokinetic parameters: Trough Concentration (Ctrough)

    Measured: during treatment, up to approximately 2 years

  8. Pharmacokinetic parameters: Accumulation Ratio (Rac)

    Measured: during treatment, up to approximately 2 years

  9. Pharmacokinetic parameters: Elimination Half-life (t1/2)

    Measured: during treatment, up to approximately 2 years

  10. Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)

    Measured: during treatment, up to approximately 2 years

  11. Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F)

    Measured: during treatment, up to approximately 2 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Measured: Up to approximately 4 years

  2. Disease control rate (DCR)

    Measured: Up to approximately 4 years

  3. Duration of Response (DOR)

    Measured: Up to approximately 4 years

  4. Time to Progression (TTP)

    Measured: Up to approximately 4 years

  5. Time to Response (TTR)

    Measured: Up to approximately 4 years

  6. progression-free survival (PFS)

    Measured: Up to approximately 4 years

  7. Overall Survival (OS)

    Measured: Up to approximately 4 years

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 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionJan 2030 (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
Sequential
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583771
Sponsor's protocol ID
CS08399-101
Status last verified
May 2026
First submitted
7 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CS08399 in people with Pancreatic Adenocarcinoma and Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site 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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Xuelian Zhou (028-64907337, zhouxuelian@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of dose-limiting toxicity (DLT) (time frame: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose). The study lists 11 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 NCT07583771.

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 2026.

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