NCT04726332

Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)

A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XL102 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, PK, antitumor activity, and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens to subjects with advanced solid tumors.

Conditions

• Neoplasm Malignant
• Epithelial Ovarian Cancer
• Triple Negative Breast Cancer
• Hormone Receptor Positive Breast Carcinoma
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	XL102	oral doses of XL102
DRUG	Fulvestrant	fulvestrant 500 mg administered as an intramuscular (IM) injection every 2 weeks for the first 3 doses and then every 4 weeks.
DRUG	Abiraterone	abiraterone 1000 mg administered orally once daily.
DRUG	Prednisone	prednisone 5 mg administered orally twice daily.

Timeline

• Start date: 2021-02-10
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2021-01-27
• Last updated: 2024-05-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study