Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Alpelisib; Drug: Sacituzumab govitecan

• Registration Number: NCT05143229
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-03
• Study Start: 2022-03-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg	Sacituzumab govitecan	Alpelisib: 300 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Dose level 3: alpelisib 300 mg plus sacituzumab govitecan 10 mg/kg	Alpelisib	Alpelisib: 300 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg	Alpelisib	Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 8 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg	Alpelisib	Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Dose level 1: alpelisib 250 mg plus sacituzumab govitecan 8 mg/kg	Sacituzumab govitecan	Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 8 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle
Dose level 2: alpelisib 250 mg plus sacituzumab govitecan 10 mg/kg	Sacituzumab govitecan	Alpelisib: 250 mg by mouth daily Sacituzumab govitecan: 10 mg/kg intravenous on days 1 and 8 of each 21 (+/-2) day cycle

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan	21 days	Standard 3+3 dose escalation design (three dose levels of alpelisib plus sacituzumab govitecan) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which \<1/6 subjects experienced a DLT.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of alpelisib when administered with sacituzumab govitecan	In cycle 1, from prior to sacituzumab govitecan dosing through 48 hours after sacituzumab govitecan dosing	Alpelisib area under the curve (AUC): blood sampling pre-dose and 0.5, 1, 2, 3, 4, 6, 24, and 48 hours post-sacituzumab govitecan dose
Pharmacokinetics of sacituzumab govitecan when administered with alpelisib	In cycle 1, from prior to sacituzumab govitecan dosing through 48 hours after sacituzumab govitecan dosing	Sacituzumab govitecan, free SN-38, and total SN-38 area under the curve (AUC): blood sampling pre-dose and 0.5, 1, 2, 3, 4, 6, 24, and 48 hours post-sacituzumab govitecan dose
Overall response rate (ORR) in patients with measurable disease	From start of study treatment until removal from study treatment; estimated 24 months maximum.	ORR includes complete response (CR) plus partial response (PR). As evaluated per RECIST version 1.1.

Trial Locations

Locations (7)

The University of Kansas Cancer Center - Overland Park; 🇺🇸 Overland Park, Kansas, United States

The University of Kansas Cancer Center - Indian Creek; 🇺🇸 Overland Park, Kansas, United States

The University of Kansas Clinical Research Center; 🇺🇸 Fairway, Kansas, United States

The University of Kansas Cancer Center - Lee's Summit; 🇺🇸 Lee's Summit, Missouri, United States

The University of Kansas Cancer Center - North; 🇺🇸 Kansas City, Missouri, United States

The University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

The University of Kansas Cancer Center - North Kansas City Hospital; 🇺🇸 Kansas City, Missouri, United States