Phase 2
Completed N=16
Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT02667886 ↗Enrolled (actual)
16
Serious AEs
40.5%
Results posted
Aug 2024
Primary outcomePrimary: Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 3; 62; 6; 3 Participants
Summary
The purpose of the study is to test different doses of X4P-001 given alone and in combination with axitinib in participants diagnosed with advanced renal cell carcinoma. The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
3; 62; 6; 3 | — |
| SECONDARY Parts A and B: Objective Response Rate (ORR), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
66.7; 27.1 | — |
| SECONDARY Parts A and B: Time to Objective Response, as Assessed Using RECIST v1.1 |
12.9; 14.6 | — |
| SECONDARY Parts A and B: Duration of Objective Response (DOR), as Assessed Using RECIST v1.1 |
NA; 16.6 | — |
| SECONDARY Parts A and B: Disease Control Rate (DCR), as Assessed Using RECIST v1.1 |
100.0; 71.2 | — |
| SECONDARY Parts A and B: Time to Progression (TTP), as Assessed Using RECIST v1.1 |
11.1; 7.4 | — |
| SECONDARY Parts A and B: Progression Free Survival (PFS), as Assessed Using RECIST v1.1 |
11.1; 7.4 | — |
| SECONDARY Parts A and B: Maximum Plasma Concentration (Cmax) of X4P-001 |
1070; 3130; 4170; 831; 3710; 3900 | — |
| SECONDARY Area Under the Curve From Time 0 to the Last Quantifiable Timepoint (AUC0-tlast) |
2200; 6790; 9830; 3000; 13100; 15100 | — |
Eligibility Criteria
Inclusion Criteria
- Have a histologically confirmed diagnosis of predominant ccRCC.
- Have received at least one prior course of treatment for ccRCC. Part C only: Prior treatment must include at least 1 course of vascular endothelial growth factor (VEGF)-directed therapy.
- Have on computed tomography (CT) imaging done within 28 days of Day 1 findings consistent with advanced ccRCC, including at least one extra-renal measurable target lesion meeting the criteria of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- For women of childbearing potential and men, agree to use effective contraceptive methods from screening, through the study, and for at least 4 weeks after the last dose of study drug.
- For women of childbearing potential, have a negative pregnancy test (serum or urine) on Day 1 prior to initiating study treatment.
- Be willing and able to comply with the protocol
Exclusion Criteria
- Has life expectancy of less than 3 months.
- Has performance status Grade >2 (Eastern Cooperative Oncology Group [ECOG] criteria).
- Has New York Heart Association (NYHA) Class III or IV heart failure or uncontrolled hypertension (systolic blood pressure [SBP] ≥160 millimeters of mercury [mm Hg]; diastolic blood pressure [DBP] ≥100 mm Hg).
- Has previously received X4P-001.
- Parts A and B only: Has received a prior course of axitinib.
- Parts A and B only: Has received mechanistic target of rapamycin (mTOR) inhibitor(s) as their only prior treatment for ccRCC.
- Has a prior history or current evidence of intracranial (CNS) metastatic RCC, except for
≤3 lesions treated by CyberKnife or excisional surgery, clinically stable for at least 4 weeks, and without evidence of recurrence on MRI imaging at screening.
- Has ongoing acute clinical adverse events National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 resulting from prior cancer therapies (except alopecia, tyrosine kinase inhibitor [TKI]-related hand-foot syndrome, or thyroid dysfunction).
- Has had within the past 6 months the occurrence or persistence of one or more of the following medical conditions that could not be controlled with usual medical care (for example, required emergency care or hospitalization): hypertension, angina, congestive heart failure, diabetes, seizure disorder.
- Has had within the past 6 months the occurrence of one or more of the following events: myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (CTC Grade 3 or 4), chronic liver disease (meeting criteria for Child-Pugh Class B or C), a second active malignancy (excluding basal cell carcinoma and cervical carcinoma in situ), organ transplantation.
- Has had within the 4 weeks prior to initiation of study drug, or is expected to have during the study period, surgery requiring general anesthesia.
- Has, at screening, serologic laboratory tests meeting one or more of the following criteria:
- An indeterminate or positive test for antibody to human immunodeficiency virus (HIV)-1 or -2.
- An indeterminate or positive test for antibody to hepatitis C virus (HCV), unless documented to have no detectable viral load on two independent samples.
- A positive test for hepatitis B surface antigen (HBsAg).
- Has, at screening, safety laboratory tests meeting one or more of the following criteria:
- Hemoglobin 2.0x upper limit of normal (ULN)
- Serum aspartate transaminase (AST) >2.5x ULN
- Serum alanine transaminase (ALT) >2.5x ULN
- Total bilirubin >1.5x ULN (unless due to Gilbert's Syndrome)
- International normalized ratio (INR) >1.5x ULN
- Has received other anti-cancer therapy within the following specified intervals prior to Day 1:
- TKI within 2 weeks.
- Radiation therapy within 2 weeks.
- Bevacizumab within 4 weeks.
- Other chemotherapy (for example, mitomycin-C, nitrosourea) or immunotherapy (for example, antibody, cytokine) within 4 weeks
- For investigational anti-cancer therapies, the interv
Data sourced from ClinicalTrials.gov (NCT02667886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.