Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors

NCT06022289 | Unknown Phase 2 DMC

• 1 other identifier: Pemigatinib for Pan-cancer
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.

Conditions

Solid Tumor; FGF Receptor Gene Mutation; FGF Amplification; FGF Receptor Gene Family Rearrangement; FGF Receptor Gene Translocation

Keywords

Solid Tumor; FGFR; Pemigatinib

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival 2/Progression-free Survival 1(PFS2/PFS1)

  The progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment.The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death.

  Through study completion, an expected average of 1 year.

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Through study completion, an expected average of 1 year.

• Progression-free Survival (PFS)

  The last subject completes at least 24 weeks of follow-up (or disease progression).

• Disease control rate (DCR)

  Through study completion, an expected average of 1 year.

• Overall survival(OS)

  Through study completion, an expected average of 2 years.

• Duration of Response(DOR)

  Through study completion, an expected average of 1 year.

Study Arms (1)

Monotherapy or combination therapy based on Pemigatinib

EXPERIMENTAL

Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.

Also known as: INCB05482

Monotherapy or combination therapy based on Pemigatinib

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 old; Gender unlimited
• Late stage, recurrent, or metastatic solid tumors confirmed by histology or cytology as unresectable by surgery.
• According to RECIST v1.1, there is at least one measurable lesion.
• Histological confirmation of FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.
• After standard treatment, the disease progresses, becomes intolerable, or standard treatment is ineffective, or there is no standard treatment plan.
• Has not previously used small molecule multi target inhibitors targeting the FGFR pathway (including arotinib, lenvatinib, sorafenib, apatinib, etc.).
• ECOG physical fitness status is 0-1.
• Expected survival time\>3 months.
• Sufficient organ function is required for the subject to meet the following laboratory indicators:
• In the past 14 days without using granulocyte colony stimulating factor, the absolute value of neutrophils (ANC) ≥ 1.5x10\^9/L.
• Platelets ≥ 100 without blood transfusion in the past 14 days × 10\^9/L.
• In the absence of blood transfusion or use of erythropoietin within the past 14 days, hemoglobin\>9g/dL.
• Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN). Or total bilirubin\>ULN but direct bilirubin ≤ ULN.
• \) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 × ULN (ALT or AST ≤ 5 allowed for patients with liver metastasis) × ULN).
• \) Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Fault formula) ≥ 50 ml/min.

You may not qualify if:

• Diagnosed within 5 years prior to the first administration as other malignant diseases outside of the current enrollment diagnosis (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection).
• Previously received selective FGFR inhibitor treatment.
• Those who have received any other study drug treatment or participated in intervention clinical studies within 28 days before the first administration. Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indications) within 28 days before the first use of the study drug.
• Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss).
• Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist. For brain metastasis subjects who have previously received treatment, if their condition is stable (there is no evidence of imaging progression within at least 4 weeks before the first administration of the trial treatment), repeated imaging examinations confirm no evidence of new brain metastasis or enlargement of existing brain metastasis lesions, and steroid treatment is not required at least 14 days before the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its clinical stability.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• The following laboratory parameters are abnormal:
• Serum phosphate\>ULN.
• Serum calcium exceeds the normal range, or when serum albumin exceeds the normal range, the corrected calcium concentration of serum albumin exceeds the normal range.
• Potassium level\<lower limit of normal value. Potassium levels can be corrected through supplementation during screening.
• Known history of human immunodeficiency virus (HIV) infection or confirmed positive immune test results.
• Severe infections with active or poorly controlled clinical conditions.
• Chest fluid, ascites, or pericardial effusion with obvious clinical symptoms that require drainage treatment.
• Individuals infected with acute or chronic active hepatitis B or hepatitis C, with hepatitis B virus (HBV) DNA\>2000IU/ml or 10\^4 copies/ml. Hepatitis C virus (HCV) RNA\>10\^3 copies/ml. Hepatitis B surface antigen (HbsAg) and anti HCV antibody were positive at the same time. Those who have undergone nucleotides based antiviral treatment and fall below the above standards can be enrolled in the group.
• Clinically significant or uncontrolled heart diseases, including unstable angina pectoris, acute myocardial infarction occurring within 6 months prior to first administration, New York Heart Association Class III/IV congestive heart failure, and uncontrolled arrhythmia (allowing subjects with pacemakers or atrial fibrillation and good heart rate control).

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Interventions

pemigatinib

Study Officials

• HaiTao Wang, Ph.D

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HaiTao Wang, Ph.D

CONTACT

+86-022-88326385; peterrock2000@126.com

Jinhuan Wang, Ph.D

CONTACT

+86-022-88326610; wjhhappy2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: September 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 31, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (1)