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

NCT07583771 | Not Yet Recruiting Phase 1

• 1 other identifier: CS08399-101
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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 MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).

Conditions

Pancreatic Adenocarcinoma; Non Small Cell Lung Cancer; Advanced Solid Tumors; Lymphoma; Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (11)

• incidence of dose-limiting toxicity (DLT)

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

• maximum tolerated dose (MTD)

  dose escalation part, up to approximately 2 year

• incidence of adverse events (AEs)

  Number of participants with AE(s)

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

• Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)

  during treatment, up to approximately 2 year

• Pharmacokinetic parameters: Maximum Concentration (Cmax)

  during treatment, up to approximately 2 year

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

  during treatment, up to approximately 2 year

• Pharmacokinetic parameters: Trough Concentration (Ctrough)

  during treatment, up to approximately 2 years

• Pharmacokinetic parameters: Accumulation Ratio (Rac)

  during treatment, up to approximately 2 years

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

  during treatment, up to approximately 2 years

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

  during treatment, up to approximately 2 years

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

  during treatment, up to approximately 2 years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to approximately 4 years

• Disease control rate (DCR)

  Up to approximately 4 years

• Duration of Response (DOR)

  Up to approximately 4 years

• Time to Progression (TTP)

  Up to approximately 4 years

• Time to Response (TTR)

  Up to approximately 4 years

Study Arms (1)

CS08399

EXPERIMENTAL

two 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.

Drug: CS08399

Interventions

CS08399 DRUG

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.

CS08399

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lymphoma; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Central Study Contacts

Xuelian Zhou

CONTACT

028-64907337; zhouxuelian@chipscreen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)