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

NCT ID: NCT06551896

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemigatinib combined with immune checkpoint inhibitor

Pemigatinib 13.5mg，two weeks on and one week off, and with immune checkpoint inhibitor selected by investigator.

Group Type: EXPERIMENTAL

Pemigatinib

Intervention Type: DRUG

Pemigatinib and immune checkpoint inhibitors

Interventions

Pemigatinib

Pemigatinib and immune checkpoint inhibitors

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

qintao

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

TAO QIN, MD

Role: CONTACT

qint6@mail.sysu.edu.cn

020-34071337

Other Identifiers

SYSKY-2024-546-01

Identifier Type: -

Identifier Source: org_study_id