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

NCT06551896 | Not Yet Recruiting Phase 2

• 1 other identifier: SYSKY-2024-546-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pemigatinib; FGFR1/2/3 alteration; Solid tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the proportion of patients with tumor shrinkage with CR and PR over 4 weeks.

  every 8 weeks during treatment

Secondary Outcomes (3)

• Disease control rate（DCR）

  every 8 weeks during during treatment

• Progression-free survival （PFS）

  every 8 weeks during treatment

• Overall survival（OS）

  every 8 weeks during treatment

Study Arms (1)

Pemigatinib combined with immune checkpoint inhibitor

EXPERIMENTAL

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

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib and immune checkpoint inhibitors

Pemigatinib combined with immune checkpoint inhibitor

Eligibility Criteria

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

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L in the past 14 days without granulocyte colony-stimulating factor;
• Platelets ≥ 100 x 10⁹/L without transfusion in the past 14 days;
• Hemoglobin \> 9 g/dL in the last 14 days without transfusion or erythropoietin;
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or total bilirubin \> ULN but direct bilirubin ≤ ULN;
• AST, ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastasis);
• Serum creatinine ≤ 1.5 x ULN and creatinine clearance (Cockcroft-Gault) ≥ 50 ml/min;
• 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;

You may not qualify if:

• 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:
• Serum phosphate \> 1.5 x ULN;
• 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Breast Neoplasms; Lung Neoplasms; Stomach Neoplasms; Sarcoma; Carcinoma

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Connective and Soft Tissue

Central Study Contacts

TAO QIN, MD

CONTACT

020-34071337; qint6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 13, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08