XL092

Phase 3Small molecule

Roche

XL092 is one of 213 small molecule programs targeting Metastatic Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

212

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Prostate CancerActive, not recruiting

Renal Cell CarcinomaActive, not recruiting

Thyroid CancerActive, not recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Squamous Cell CarcinomaActive, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 1/Phase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Renal Cell CarcinomaPhase 3

Active, not recruiting

Thyroid CancerPhase 1

Active, not recruiting

Metastatic Castration-Resistant Prostate CancerPhase 2

Recruiting

Squamous Cell CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

XL092

Roche

Phase 3

1 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

PORTRAZZA

Eli Lilly

Preclinical

8 5

Imjudo

AstraZeneca

Preclinical

5 6

Gilotrif

Boehringer Ingelheim

Preclinical

12 7

Ofev

Boehringer Ingelheim

Preclinical

7 8

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 9

Remeron

OOrganon and Co

Preclinical

1 10

Vidaza

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Metastatic Colorectal Cancer

NCT05425940

Q2 2027

Phase 1Active, not recruiting

Combination Therapy

NCT03845166

Q2 2028

Phase 2Not yet recruiting

Squamous Cell Carcinoma

NCT07484139

Phase 3Active, not recruiting

Renal Cell Carcinoma

NCT05678673

Q3 2028

Phase 1Recruiting

Thyroid Cancer

NCT06902376

Clinical

Trials by Indication[1]

Thyroid Cancer1 trial

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT06902376·12 enrolled

Renal Cell Carcinoma1 trial

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Active, not recruiting·EExelixis·Phase 3·NCT05678673·317 enrolled

Combination Therapy1 trial

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Active, not recruiting·EExelixis·Phase 1·NCT03845166·325 enrolled

Squamous Cell Carcinoma1 trial

H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)

Not yet recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT07484139·26 enrolled

Non-Small Cell Lung Cancer1 trial

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03337698·314 enrolled

3 more indications

Metastatic Colorectal Cancer1 trial

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Active, not recruiting·EExelixis·Phase 3·NCT05425940·901 enrolled

Adjuvant Therapy1 trial

Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Recruiting·KKarie Runcie·Phase 2·NCT06863311·70 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617

Recruiting·UUniversity of Utah·Phase 2·NCT06568562·32 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for XL092. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — XL092 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for XL092. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Roche

XL092

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q2 2028

Q3 2028

Trials by Indication[1]

Thyroid Cancer1 trial

Renal Cell Carcinoma1 trial

Combination Therapy1 trial

Squamous Cell Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Metastatic Colorectal Cancer1 trial

Adjuvant Therapy1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

References

Drug Info

Quick Facts

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