STELLAR 001

Active, Not Recruiting

Phase 1 Dose-Escalation and Expansion Study of Zanzalintinib (XL092) Alone or in Combination in Locally Advanced or Metastatic Solid Tumors

USES AND/OR COMPOUNDS DESCRIBED HERE ARE INVESTIGATIONAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.

Study Overview
Key Eligibility Criteria
Key Endpoints
Participating Sites

Study Overview

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of Zanzalintinib as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors.

Zanzalintinib Single-Agent Evaluation

Dose-Escalation Stage

Cohort Expansion Stage

Key Eligibility Criteria

Dose-Escalation Stage

Unresectable or metastatic solid tumor for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective
ECOG 0-1

Cohort Expansion Stage

Click “+” to expand and learn more

ccRCC

Clear Cell Renal Cell Carcinoma (ccRCC)

Advanced or metastatic renal cell carcinoma with clear cell histology (sarcomatoid component allowed)
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

nccRCC

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Advanced or metastatic renal cell carcinoma with non–clear cell histology
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

mCRPC

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Metastatic castration-resistant prostate cancer with progressive disease defined by PSA or soft tissue progression
Prior treatment with taxane-based chemotherapy for mCRPC
Prior treatment with at least 1 NHT for locally advanced or mCSPC, M0 CRPC, or mCRPC
≤4 prior systemic regimens
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

HR+ BC

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Advanced or metastatic breast cancer that is hormone receptor positive and HER-2 negative
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

ccRCC

nccRCC

mCRPC

HR+ BC

Clear Cell Renal Cell Carcinoma (ccRCC)

Advanced or metastatic renal cell carcinoma with clear cell histology (sarcomatoid component allowed)
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Advanced or metastatic renal cell carcinoma with non–clear cell histology
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Metastatic castration-resistant prostate cancer with progressive disease defined by PSA or soft tissue progression
Prior treatment with taxane-based chemotherapy for mCRPC
Prior treatment with at least 1 NHT for locally advanced or mCSPC, M0 CRPC, or mCRPC
≤4 prior systemic regimens
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Advanced or metastatic breast cancer that is hormone receptor positive and HER-2 negative
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Zanzalintinib + Atezolizumab Combination Evaluation

Dose-Escalation Stage

Cohort Expansion Stage

Key Eligibility Criteria

Dose-Escalation Stage

Unresectable or metastatic solid tumor for which no SOC treatment is available
ECOG 0-1

Cohort Expansion Stage

Click “+” to expand and learn more

nccRCC

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Advanced or metastatic renal cell carcinoma with non–clear cell histology
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

HR+ BC

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Advanced or metastatic breast cancer that is hormone receptor positive and HER-2 negative
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

mCRPC

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Metastatic castration-resistant prostate cancer with progressive disease defined by PSA or soft tissue progression
Prior treatment with taxane-based chemotherapy for mCRPC
Prior treatment with at least 1 NHT for locally advanced or mCSPC, M0 CRPC, or mCRPC
≤4 prior systemic regimens
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

CRC

Colorectal Cancer (CRC)

MSS/MSI-low metastatic colorectal adenocarcinoma with measurable disease
KRAS/NRAS WT
Progressed, refractory, or intolerant to all of the following SOC regimens for mCRC:
- Fluoropyrimidine, irinotecan, and oxaliplatin, ± anti-VEGF mAb
- Anti-EGFR mAb
- BRAF inhibitor for known BRAF V600E mutations
Progression ≤3 months following the last dose of SOC regimen
No prior regorafenib and/or TAS-102

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

nccRCC

HR+ BC

mCRPC

CRC

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Advanced or metastatic renal cell carcinoma with non–clear cell histology
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Metastatic castration-resistant prostate cancer with progressive disease defined by PSA or soft tissue progression
Prior treatment with taxane-based chemotherapy for mCRPC
Prior treatment with at least 1 NHT for locally advanced or mCSPC, M0 CRPC, or mCRPC
≤4 prior systemic regimens
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Advanced or metastatic breast cancer that is hormone receptor positive and HER-2 negative
Progression following at least 1 but no more than 3 lines of prior systemic anticancer therapies
Combination cohort—no prior ICI therapy

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Colorectal Cancer (CRC)

MSS/MSI-low metastatic colorectal adenocarcinoma with measurable disease
KRAS/NRAS WT
Progressed, refractory, or intolerant to all of the following SOC regimens for mCRC:
- Fluoropyrimidine, irinotecan, and oxaliplatin, ± anti-VEGF mAb
- Anti-EGFR mAb
- BRAF inhibitor for known BRAF V600E mutations
Progression ≤3 months following the last dose of SOC regimen
No prior regorafenib and/or TAS-102

Note: Prior neoadjuvant/adjuvant or maintenance therapies are allowed and will not count toward the maximum allowed number of systemic regimens.

Zanzalintinib + Avelumab Combination Evaluation

Dose-Escalation Stage

Key Eligibility Criteria

Dose-Escalation Stage

Unresectable or metastatic solid tumor for which no SOC treatment is available
ECOG 0-1

Key Endpoints

Dose-Escalation Stage

Primary Endpoint

Determine MTD and/or RD

Secondary Endpoints

Safety
PK

Exploratory Endpoint

ORR by investigator

Cohort Expansion Stage

Primary Endpoints

ORR by investigator
PFS rate by investigator (except for CRC cohort)
OS (for RAS^WT, CRC cohort)

Secondary Endpoint

Safety

Exploratory Endpoints

DOR by investigator
PFS by investigator
ORR, DOR, and PFS by BIRC
OS

BIRC, blinded independent radiology committee; ccRCC, clear cell renal cell carcinoma; CRC, colorectal cancer; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HER-2, human epidermal growth factor receptor 2; HR+ BC, hormone receptor–positive breast cancer; ICI, immune checkpoint inhibitor; IV, intravenous; M0 CRPC, non-metastatic castration-resistant prostate cancer; mAb, monoclonal antibody; mCRC, metastatic colorectal cancer; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; MSI, microsatellite instability; MSS, microsatellite stable; MTD, maximum tolerated dose; nccRCC, non–clear cell renal cell carcinoma; NHT, novel hormonal therapy; ORR, objective response rate; OS, overall survival; PD-1, programmed death receptor-1; PD-L1, programmed death receptor-1 ligand; PFS, progression-free survival; PK, pharmacokinetics; PSA, prostate-specific antigen; q2w, once every 2 weeks; q3w, once every 3 weeks; qd, once daily; RD, recommended dose; SC, steering committee; SOC, standard of care; VEGF, vascular endothelial growth factor; VEGFR, vascular endothelial growth factor receptor; WT, wild-type.

Participating Sites

STELLAR-001 will be conducted in North America, Europe, Middle East, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

To learn more about this trial, go to clinicaltrials.gov and search for NCT03845166, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or medinfo@exelixis.com.

Phase 1 Dose-Escalation and Expansion Study of Zanzalintinib (XL092) Alone or in Combination in Locally Advanced or Metastatic Solid Tumors

Study Overview

Zanzalintinib Single-Agent Evaluation

Dose-Escalation Stage

Cohort Expansion Stage

Key Eligibility Criteria

Dose-Escalation Stage

Cohort Expansion Stage

Clear Cell Renal Cell Carcinoma (ccRCC)

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Clear Cell Renal Cell Carcinoma (ccRCC)

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Zanzalintinib + Atezolizumab Combination Evaluation

Dose-Escalation Stage

Cohort Expansion Stage

Key Eligibility Criteria

Dose-Escalation Stage

Cohort Expansion Stage

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Colorectal Cancer (CRC)

Non–Clear Cell Renal Cell Carcinoma (nccRCC)

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Hormone Receptor–Positive Breast Cancer (HR+ BC)

Colorectal Cancer (CRC)

Zanzalintinib + Avelumab Combination Evaluation

Dose-Escalation Stage

Key Eligibility Criteria

Dose-Escalation Stage

Key Endpoints

Dose-Escalation Stage

Primary Endpoint

Secondary Endpoints

Exploratory Endpoint

Cohort Expansion Stage

Primary Endpoints

Secondary Endpoint

Exploratory Endpoints

Participating Sites

To learn more about this trial, go to clinicaltrials.gov and search for NCT03845166, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free), 1-303-389-1847, or medinfo@exelixis.com.

To learn more about this trial, go to clinicaltrials.gov and search for NCT03845166, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or medinfo@exelixis.com.