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OncoMatch/Clinical Trials/NCT06224387

CTS2190 Phase I /II Clinical Study in Patients

Is NCT06224387 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CTS2190 capsules for solid tumors.

Phase 1/2RecruitingCytosinLab Therapeutics Co., Ltd.NCT06224387Data as of May 2026

Treatment: CTS2190 capsulesThis is a first in human study in patients with advanced or metastatic solid tumors. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific tumor types. The study drug, CTS2190, is a PRMT1 inhibitor administered orally. The study is planned to treat up to 224 participants.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Pancreatic Cancer

Non-Small Cell Lung Carcinoma

Triple-Negative Breast Cancer

Breast Carcinoma

Disease stage

Required: Stage III, IV

locally advanced or metastatic solid tumors at screening who cannot be treated surgically

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard treatment

have failed standard treatment (PD during treatment or after the last treatment) recommended by the current clinical diagnosis and treatment standards or guidelines, or cannot tolerate standard treatment, or refuse standard treatment and/or currently have no effective treatment available

Cannot have received: radiotherapy for the target lesion

Treatment with radiotherapy for the target lesion within 4 weeks before the first administration of the investigational drug

Cannot have received: anti-tumor drugs/treatments (including but not limited to chemotherapy, targeted therapy, immunotherapy)

accepted any anti-tumor drugs/ treatments (including but not limited to chemotherapy, targeted therapy, immunotherapy) within 5 half-lives before the first administration of the investigational drug, whichever is longer

Cannot have received: herbal therapies with anti-tumor indications

patients who have received herbal therapies with anti-tumor indications within 1 week before the first administration

Cannot have received: other unlisted clinical investigational drugs or treatments

received other unlisted clinical investigational drugs or treatments within 4 weeks (or 5 drug half-lives, whichever is longer) before the first administration

Lab requirements

Blood counts

platelet ≥ lower limit of normal, ANC ≥ 1.5 × 10^9/L, hemoglobin ≥ 100 g/dL

Kidney function

blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)

Liver function

TBIL ≤ 1.5 × ULN (exceptions for isolated bilirubin >1.5 × ULN if direct bilirubin <35% or Gilbert syndrome), ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN (with liver mets: ALT/AST ≤ 5 × ULN)

Cardiac function

QTcF ≤ 450 ms (male) or ≤ 470 ms (female)

good organ function at screening, including: Liver function: total bilirubin (TBIL) ≤ 1.5 × ULN ... ALT ≤ 2.5 × ULN ... AST ≤ 2.5 × ULN (for patients with liver metastases ... ALT ≤5 × ULN, AST ≤ 5 × ULN); Renal function: blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min ... Hematology: platelet ≥ the lower limit of the laboratory normal range, and absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, and hemoglobin ≥ 100 g/dL; Cardiac function: QTcF ≤ 450 ms (male) or ≤ 470 ms (female)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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