Urothelial CarcinomaPhase 2NCT06551896
Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor
A Phase 2 study testing Pemigatinib in people with Urothelial Carcinoma and Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Breast Neoplasms, Lung Cancer
- What is being tested?
- Pemigatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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;
- 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).
Who cannot join
- 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;
Show all 24Show fewer
- 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;
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)
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
- Being tested
- Pemigatinib
- Keywords
- Pemigatinib, FGFR1/2/3 alteration, Solid tumor
- Medical subject headings
- Carcinoma, Transitional Cell, Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms, Sarcoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Pemigatinib and immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
the proportion of patients with tumor shrinkage with CR and PR over 4 weeks.
Measured: every 8 weeks during treatment
Secondary outcomes (3)
Disease control rate（DCR）
The proportion of patients with CR, PR and SD.
Measured: every 8 weeks during during treatment
Progression-free survival （PFS）
PFS was defined as the time from random assignment to progression or death. Patients alive who had not experienced progression as of the analysis cutoff date were censored at the last disease assessment.
Measured: every 8 weeks during treatment
Overall survival（OS）
OS was defined as the time from random assignment to death. For patients alive at the data cutoff date, OS was censored at the last follow-up date.
Measured: every 8 weeks during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, qintao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551896
- Sponsor's protocol ID
- SYSKY-2024-546-01
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)
- ClinicalTrials.gov ID
- NCT06551896
- Acronym / sponsor ID
- SYSKY-2024-546-01
- Conditions
- Urothelial Carcinoma, Breast Neoplasms, Lung Cancer, Gastric Cancer, Soft Tissue Sarcoma, Other Carcinoma
- Keywords
- Pemigatinib, FGFR1/2/3 alteration, Solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemigatinib combined with immune checkpoint inhibitor | Experimental | Drug: PemigatinibPemigatinib 13.5mg，two weeks on and one week off, and with immune checkpoint inhibitor selected by investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinibPemigatinib and immune checkpoint inhibitors | Drug | Pemigatinib combined with immune checkpoint inhibitor |
Primary outcome
Objective response rate (ORR)
Time frame: every 8 weeks during treatment
the proportion of patients with tumor shrinkage with CR and PR over 4 weeks.
3 secondary outcomes
Disease control rate（DCR）
Time frame: every 8 weeks during during treatment
Progression-free survival （PFS）
Time frame: every 8 weeks during treatment
Overall survival（OS）
Time frame: every 8 weeks during treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Related trials for Urothelial Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib in people with Urothelial Carcinoma and Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TAO QIN, MD (020-34071337, qint6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: every 8 weeks during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.