NCT07007559

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.

Detailed description

Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor. As ASPEN-09-03 (MBC) is the only substudy open under ASPEN-09, the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria currently includes only MBC.

Conditions

• Breast Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	Evorpacept (ALX148)	IV infusion
DRUG	Trastuzumab	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Capecitabine	Oral administration
DRUG	Eribulin	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Vinorelbine	IV infusion

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-06-06
• Last updated: 2026-04-13

Locations

32 sites across 7 countries: United States, France, Italy, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study