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

Conditions

• Breast Cancer, Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Evorpacept (ALX148) — DRUG
  IV infusion
• Trastuzumab — DRUG
  IV infusion
• Paclitaxel — DRUG
  IV infusion
• Capecitabine — DRUG
  Oral administration
• Eribulin — DRUG
  IV infusion
• Gemcitabine — DRUG
  IV infusion
• Vinorelbine — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Dec 10, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer
  * Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - once every 3 weeks (Q3W) * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) twice a day for 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine (IV) twice every 3 weeks * Paclitaxel (IV) once every 3 weeks (Q3W) or once weekly (QW) * Vinolrebine (IV) twice every 3 weeks

Primary Outcome Measure

Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment [ Time Frame: Approximately 6 months after the last participant is enrolled ]

Central Contacts

• Cheng Quah, MD
  650-466-7125
  [email protected]

Locations (21)

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