STELLAR-001

19 evidence topics · 6 sources

Objective

Dose-escalation objective

“determine MTDs/RDs of XL092” (opens the source at this quote in a new tab)

Randomized colorectal expansion-cohort objective

“investigator-assessed ORR” (opens the source at this quote in a new tab)

Location and study date

Colorectal expansion-cohort abstract data cutoff

“May 6, 2024” (opens the source at this quote in a new tab)

Study design

Early protocol design

“multi-center, phase 1, open-label study” (opens the source at this quote in a new tab)

STELLAR-001: randomized expansion cohort

“Pts were randomized 1:1 to receive zanza+atezo (100 mg QD + 1200 mg Q3W) or single-agent zanza (100 mg QD).” (opens the source at this quote in a new tab)

Eligibility criteria

Colorectal expansion-cohort RAS eligibility

“RAS -wildtype” (opens the source at this quote in a new tab)

Colorectal expansion-cohort performance-status eligibility

“ECOG PS of 0/1” (opens the source at this quote in a new tab)

Treatment

Randomized expansion-cohort treatment

“Pts were randomized 1:1 to receive zanza+atezo (100 mg QD + 1200 mg Q3W) or single-agent zanza (100 mg QD).” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using RECIST 1.1 objective response rate as a primary expansion-stage endpoint

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

Earlier whole-study planned enrollment across tumor cohorts

Population	Quoted planned participants
Whole study	“800”

STELLAR-001: colorectal expansion-cohort enrollment

Outcome	Zanzalintinib alone	Zanzalintinib plus atezolizumab
Patients	“53”	“54”

Description of analysis sets

Earlier protocol dose-escalation and expansion methods

Protocol component	Quoted design
Monotherapy dose escalation	“3+3 design”
Combination dose escalation	“rolling 6 design”
Tumor-specific monotherapy expansion	“Simon’s optimal 2-stage design”

Results

Participant disposition

Study-treatment discontinuation at the abstract cutoff

Treatment group	Quoted proportion
Zanzalintinib plus atezolizumab	“89%”
Zanzalintinib alone	“94%”

Baseline characteristics

Median age in the colorectal expansion cohort

Treatment-group order	Quoted age
Combination followed by monotherapy, years	“61/60”

Efficacy results

STELLAR-001: overall expansion-cohort efficacy

Outcome	Zanzalintinib alone	Zanzalintinib plus atezolizumab
Median progression-free survival, months	“3.0”	“4.0”
Median overall survival, months	“11.1”	“11.7”
Objective response rate, %	“1.9”	“7.4”

STELLAR-001: overall expansion-cohort hazard ratios

Comparison: combination versus monotherapy	Direct quotation
Progression-free survival hazard ratio, 95% confidence interval	“0.65 (0.42-0.99)”
Overall survival hazard ratio, 95% confidence interval	“0.89 (0.56-1.42)”

STELLAR-001: subgroup without liver metastases

Outcome	Zanzalintinib alone	Zanzalintinib plus atezolizumab
Patients	“17”	“17”
Median progression-free survival, months	“3.3”	“8.2”
Median overall survival, months	“21.1”	“18.5”

STELLAR-001: hazard ratios in the subgroup without liver metastases

Comparison: combination versus monotherapy	Direct quotation
Progression-free survival hazard ratio, 95% confidence interval	“0.37 (0.15-0.91)”
Overall survival hazard ratio, 95% confidence interval	“0.74 (0.27-2.04)”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

STELLAR-001: overall expansion-cohort safety

Outcome	Zanzalintinib alone	Zanzalintinib plus atezolizumab
Grade 3/4 treatment-related adverse events	“40%”	“48%”

Study limitations

Summary

The colorectal expansion cohort enrolled 107 participants, including 53 assigned to zanzalintinib alone and 54 assigned to zanzalintinib plus atezolizumab. Eligibility required RAS wild-type disease and ECOG performance status 0–1. The subgroup without liver metastases contained 17 participants in each group. The company-reported overall-survival hazard ratio was 0.89 with a 95% confidence interval of 0.56–1.42; the corresponding subgroup interval was 0.27–2.04. These small cohorts and intervals crossing 1 limit conclusions about a survival difference. The comparison against zanzalintinib monotherapy does not establish comparative effectiveness against an approved later-line regimen.