Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:15 PM
Study NCT ID:
NCT07043608
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases
Sponsor:
Kelly Fitzgerald, MD
Organization:
Study Overview
Official Title:
A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZAMBONI
Brief Summary:
This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate progression-free survival (PFS) at 12 months in participants with RECIST-measurable metastatic RCC and bone metastases at baseline, and who have been previously treated with contemporary IO-based therapy.
SECONDARY OBJECTIVES:
I. To determine the rate of skeletal-related events (SRE).
II. To determine the rate of osteonecrosis of the jaw (ONJ).
III. To determine the rate of systemic toxicity.
IV. To determine median overall PFS.
V. To determine median overall survival (OS) in participants.
VI. To evaluate the objective response rate (ORR) in participants with measurable disease at baseline according to RECIST v 1.1.
VII. To evaluate PFS at 24 months in patients with Response Evaluation Criteria in Solid Tumors (RECIST)-measurable disease (metastatic RCC and bone metastases) at baseline.
EXPLORATORY OBJECTIVES:
I. To evaluate the impact of treatment on osseous microenvironment including immune and metabolic microenvironment using Flow cytometry, bulk Ribonucleic acid sequencing (RNA-seq), Single-cell RNA sequencing (scRNA-seq), Immunohistochemistry (IHC), spatial genomic and/or proteomic profiling.
II. Describe changes in quality of life (HRQoL) using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30).
OUTLINE:
Participants will receive zanzalintinib and continue until criteria for removal from study are met. Investigator-choice bone-strengthening agent (BSA) will be administered at a standard dose/interval starting within 30 days of first study treatment. Non-investigational Radiation therapy (RT) for symptomatic metastases, including bone metastases, is allowed per investigator discretion. Participants may continue study treatment until unacceptable toxicity or demonstrated disease progression, or death whichever occurs first and followed for survival for up to 24 months.
I. To evaluate progression-free survival (PFS) at 12 months in participants with RECIST-measurable metastatic RCC and bone metastases at baseline, and who have been previously treated with contemporary IO-based therapy.
SECONDARY OBJECTIVES:
I. To determine the rate of skeletal-related events (SRE).
II. To determine the rate of osteonecrosis of the jaw (ONJ).
III. To determine the rate of systemic toxicity.
IV. To determine median overall PFS.
V. To determine median overall survival (OS) in participants.
VI. To evaluate the objective response rate (ORR) in participants with measurable disease at baseline according to RECIST v 1.1.
VII. To evaluate PFS at 24 months in patients with Response Evaluation Criteria in Solid Tumors (RECIST)-measurable disease (metastatic RCC and bone metastases) at baseline.
EXPLORATORY OBJECTIVES:
I. To evaluate the impact of treatment on osseous microenvironment including immune and metabolic microenvironment using Flow cytometry, bulk Ribonucleic acid sequencing (RNA-seq), Single-cell RNA sequencing (scRNA-seq), Immunohistochemistry (IHC), spatial genomic and/or proteomic profiling.
II. Describe changes in quality of life (HRQoL) using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30).
OUTLINE:
Participants will receive zanzalintinib and continue until criteria for removal from study are met. Investigator-choice bone-strengthening agent (BSA) will be administered at a standard dose/interval starting within 30 days of first study treatment. Non-investigational Radiation therapy (RT) for symptomatic metastases, including bone metastases, is allowed per investigator discretion. Participants may continue study treatment until unacceptable toxicity or demonstrated disease progression, or death whichever occurs first and followed for survival for up to 24 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-04328 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |