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Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Not yet enrolling
Phase 2

Conditions

Gastric Cancer
Soft Tissue Sarcoma
Urothelial Carcinoma
Other Carcinoma
Lung Cancer
Breast Neoplasms

Treatments

Drug: Pemigatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT06551896
SYSKY-2024-546-01

Details and patient eligibility

About

This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1/2/3 variant advanced solid tumors.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years;

  • Histologically or cytologically confirmed unresectable advanced solid tumors with failure or intolerance to standard treatments;

  • At least one measurable lesion per RECIST v1.1 criteria;

  • Gene testing confirms FGFR1/2/3 variants, including but not limited to mutations, fusions/rearrangements in solid tumors;

  • Patients have not previously used specific small molecule multi-target inhibitors of the FGFR pathway, as assessed by investigators, and have been treated with immune checkpoint inhibitors;

  • ECOG performance status of 0-1;

  • Expected survival time > 3 months;

  • Laboratory criteria:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L in the past 14 days without granulocyte colony-stimulating factor;
    2. Platelets ≥ 100 x 10⁹/L without transfusion in the past 14 days;
    3. Hemoglobin > 9 g/dL in the last 14 days without transfusion or erythropoietin;
    4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or total bilirubin > ULN but direct bilirubin ≤ ULN;
    5. AST, ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastasis);
    6. Serum creatinine ≤ 1.5 x ULN and creatinine clearance (Cockcroft-Gault) ≥ 50 ml/min;
    7. Good coagulation function, defined as INR or PT ≤ 1.5 x ULN. If on anticoagulant therapy, PT should be within the therapeutic range of anticoagulants;
  • Female subjects of reproductive age must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1, Day 1). If the urine test is inconclusive, a blood test is required. Non-reproductive females are defined as post-menopausal for at least one year or surgically sterile;

  • Subjects with reproductive potential must use contraception with an annual failure rate of less than 1% during treatment and for 120 days after the last study drug dose (or 180 days after the last chemotherapy dose).

Exclusion criteria

  • Diagnosis of other malignancies within 3 years before the first dose, except for certain treated skin carcinomas and in-situ carcinomas;

  • Previous treatment with selective FGFR inhibitors;

  • Receipt of other investigational drugs within 21 days or antitumor drugs within 14 days before the first dose;

  • Unresolved toxicity from prior treatments unless ≤ Grade 1 or related to alopecia or fatigue;

  • Known symptomatic CNS metastasis or carcinomatous meningitis. Stable patients post-treatment with no evidence of progression may be eligible if steroid-free for at least 14 days;

  • History of allogeneic organ or hematopoietic stem cell transplantation;

  • Abnormal laboratory parameters:

    1. Serum phosphate > 1.5 x ULN;
    2. Elevated serum calcium or albumin-adjusted calcium outside the reference range;
  • Known HIV infection or positive HIV test;

  • Active or poorly controlled serious infection;

  • Need for drainage treatment for pleural effusion, ascites, or pericardial effusion;

  • Active hepatitis B or C infection with high viral load, or positive HBsAg or anti-HCV antibodies. Patients on antiviral therapy must meet lower thresholds;

  • Significant uncontrolled heart disease, including recent MI, severe heart failure, or uncontrolled arrhythmias;

  • Clinically significant ECG changes or history of significant cardiac issues; Screening QTcF interval > 480 ms, or JTc interval if applicable, must be ≤ 340 ms;

  • Uncontrolled hypertension despite treatment;

  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or higher cirrhosis;

  • Major surgery within 4 weeks before the first dose or planned major surgery during the study;

  • Unresolved complications from prior surgery;

  • Pregnant or breastfeeding women, or those planning to become pregnant during the study period and for safety follow-up;

  • Radiotherapy within 4 weeks before the first dose, except for non-CNS palliative radiotherapy with a 2-week washout period;

  • History of systemic electrolyte imbalance or ectopic soft tissue calcification;

  • Clinically significant corneal or retinal disease;

  • Use of potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before the first dose;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Pemigatinib combined with immune checkpoint inhibitor
Experimental group
Description:
Pemigatinib 13.5mg,two weeks on and one week off, and with immune checkpoint inhibitor selected by investigator.
Treatment:
Drug: Pemigatinib

Trial contacts and locations

0

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Central trial contact

TAO QIN, MD

Data sourced from clinicaltrials.gov

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