XL092

Phase 3Small molecule

Roche

XL092 is one of 124 small molecule programs targeting Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

Colorectal CancerActive, not recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Non-Clear Cell Renal Cell CarcinomaActive, not recruiting

Oral Cavity Squamous Cell CarcinomaNot yet recruiting

Combination TherapyActive, not recruiting

Adjuvant TherapyRecruiting

Colorectal CancerPhase 3

Active, not recruiting

Metastatic Castration-Resistant Prostate CancerPhase 2

Recruiting

Non-Clear Cell Renal Cell CarcinomaPhase 3

Active, not recruiting

Oral Cavity Squamous Cell CarcinomaPhase 2

Not yet recruiting

Combination TherapyPhase 1

Active, not recruiting

Adjuvant TherapyPhase 2

Recruiting

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Vectibix

Amgen

Phase 3

32 2

Keytruda

Merck & Co.

Phase 3

25 3

Beyfortus

BeiGene

Phase 3

17 4

Fudr

Pfizer

Phase 3

16 5

Tecentriq

Roche

Phase 3

6 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

3 7

Systemic Chemotherapy

SSun Yat-sen University

Phase 3

5 8

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

4 9

PD-1 Monoclonal Antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 10

XL092

Roche

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Colorectal Cancer

NCT05425940

Q2 2027

Phase 1Active, not recruiting

Combination Therapy

NCT03845166

Q2 2028

Phase 2Not yet recruiting

Oral Cavity Squamous Cell Carcinoma

NCT07484139

Phase 3Active, not recruiting

Non-Clear Cell Renal Cell Carcinoma

NCT05678673

Q3 2028

Phase 1Recruiting

Anaplastic Thyroid Cancer

NCT06902376

Clinical

Trials by Indication[1]

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

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

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

Anaplastic Thyroid Cancer1 trial

NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study

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

Oral Cavity 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

3 more indications

Non-Clear Cell Renal Cell Carcinoma1 trial

A Randomized Open-Label Phase 3 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

Colorectal Cancer1 trial

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

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

Non-Small Cell Lung Cancer1 trial

Combination Therapy1 trial

Adjuvant Therapy1 trial

Anaplastic Thyroid Cancer1 trial

Oral Cavity Squamous Cell Carcinoma1 trial

Non-Clear Cell Renal Cell Carcinoma1 trial

Colorectal Cancer1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

References

Drug Info

Quick Facts

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