Trial Title:
Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)
NCT ID:
NCT06191796
Condition:
Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Nivolumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
zanzalintinib
Description:
Specified doses on specified days
Arm group label:
Dose-finding Cohort A: Zanzalintinib + AB521
Arm group label:
Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab
Arm group label:
Expansion Cohort 1: Zanzalintinib + AB521
Arm group label:
Expansion Cohort 2: zanzalintinib + AB521 + nivolumab
Other name:
XL092
Intervention type:
Drug
Intervention name:
AB521
Description:
Specified doses on specified days
Arm group label:
Dose-finding Cohort A: Zanzalintinib + AB521
Arm group label:
Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab
Arm group label:
Expansion Cohort 1: Zanzalintinib + AB521
Arm group label:
Expansion Cohort 2: zanzalintinib + AB521 + nivolumab
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Specified doses on specified days
Arm group label:
Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab
Arm group label:
Expansion Cohort 2: zanzalintinib + AB521 + nivolumab
Other name:
OPDIVO®
Summary:
The goal of this clinical trial is to learn about the safety and preliminary antitumor
activity of zanzalintinib in combination with AB521 (doublet) and in combination with
AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced
solid tumors. The main questions it aims to answer are:
- The recommended doses (RDs)
- The safety and tolerability
- The PK and the preliminary efficacy
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Participants with unresectable advanced or metastatic disease or 1L or 2L+ clear
cell Renal cell carcinoma.
2. Have not received HIF-2α targeted therapy previously.
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors version
1.1 (RECIST 1.1; Eisenhauer et al, 2009) as determined by the Investigator.
4. For all participants, archival tumor tissue material should be obtained; if archival
tissue is not available or is older than 2 years, then a fresh biopsy should be
obtained, if medically feasible. Specific requirements for tumor tissue samples will
be described in the Laboratory Manual.
5. Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events
(CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed
clinically nonsignificant by the Investigator and/or stable on supportive therapy.
6. Karnofsky Performance Status (KPS) ≥70%.
7. Screening ambulatory oxygen saturation (SpO2) ≥92%.
8. Screening left ventricular ejection fraction (LVEF) above the institutional lower
limit of normal.
Key Exclusion Criteria:
1. Participants who have been previously treated with a HIF-2α targeted therapy and/or
zanzalintinib.
2. Radiation therapy for bone metastases within 2 weeks, any other radiation therapy
within 4 weeks before first dose of study treatment. Participants with
clinically-relevant ongoing complications from prior radiation therapy are not
eligible.
3. Known brain metastases or cranial epidural disease unless adequately treated with
radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks
before first dose of study treatment.
4. Concomitant anticoagulation with oral anticoagulants except for 1) prophylactic use
of low-dose aspirin for cardioprotection or low dose low molecular weight heparins
(LMWH) or 2) therapeutic doses of LMWH or specified direct factor Xa inhibitors.
5. Administration of a live, attenuated vaccine within 30 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Exelixis Site #8
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Facility:
Name:
Exelixis Site #9
Address:
City:
Miami
Zip:
33176
Country:
United States
Facility:
Name:
Exelixis Clinical Site #1
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
Exelixis Site #11
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Exelixis Site #6
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Facility:
Name:
Exelixis Site #5
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Exelixis Site #15
Address:
City:
Bronx
Zip:
10469
Country:
United States
Facility:
Name:
Exelixis Clinical Site #3
Address:
City:
New Hyde Park
Zip:
11776
Country:
United States
Facility:
Name:
Exelixis Site #14
Address:
City:
New York
Zip:
10028
Country:
United States
Facility:
Name:
Exelixis Site #13
Address:
City:
Shirley
Zip:
11987
Country:
United States
Facility:
Name:
Exelixis Clinical Site #2
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Exelixis Clinical Site #16
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Exelixis Site #4
Address:
City:
Spokane
Zip:
99208
Country:
United States
Facility:
Name:
Exelixis Site #12
Address:
City:
Madison
Zip:
53792
Country:
United States
Start date:
January 25, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Exelixis
Agency class:
Industry
Collaborator:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Exelixis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06191796
