ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Phase 1

Recruiting

• Conditions: Breast Cancer, Metastatic; Colorectal Cancer
• Interventions: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Cetuximab; Drug: Paclitaxel; Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin); Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

• Registration Number: NCT07007559
• Lead Sponsor: ALX Oncology Inc.

Brief Summary

The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:

* Metastatic HER2+ breast cancer (MBC) - randomized 1:1 to one of two arms (evorpacept + standard of care therapy vs. standard of care only)

* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs

* Recurrent/metastatic head and neck cancer (HNSCC) - note that this substudy will not be open at the time of study initiation

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.

Not all substudies may be active and/or open to enrollment at a given time. Not all study centers may be participating in every substudy.

Study Timeline

• Study Start: 2025-04-28
• Study First Submitted: 2025-05-22
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Evorpacept (ALX148)	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Trastuzumab	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Eribulin	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Paclitaxel	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Capecitabine	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Eribulin	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Gemcitabine	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Trastuzumab	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Paclitaxel	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Capecitabine	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Evorapacept + cetuximab + FOLFIRI in colorectal cancer participants	Evorpacept (ALX148)	Regimen A * Evorpacept (IV) weekly (QW). Dose tbd based on cohort assigned * Cetuximab (IV) QW * FOLFIRI (IV) every 2 weeks (Q2W) * Regimen B * Evorpacept (IV) every 2 weeks (Q2W). Dose tbd based on cohort assigned * Cetuximab (IV) Q2W * FOLFIRI (IV) Q2W
Evorapacept + cetuximab + FOLFIRI in colorectal cancer participants	Cetuximab	Regimen A * Evorpacept (IV) weekly (QW). Dose tbd based on cohort assigned * Cetuximab (IV) QW * FOLFIRI (IV) every 2 weeks (Q2W) * Regimen B * Evorpacept (IV) every 2 weeks (Q2W). Dose tbd based on cohort assigned * Cetuximab (IV) Q2W * FOLFIRI (IV) Q2W
Evorapacept + cetuximab + FOLFIRI in colorectal cancer participants	FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)	Regimen A * Evorpacept (IV) weekly (QW). Dose tbd based on cohort assigned * Cetuximab (IV) QW * FOLFIRI (IV) every 2 weeks (Q2W) * Regimen B * Evorpacept (IV) every 2 weeks (Q2W). Dose tbd based on cohort assigned * Cetuximab (IV) Q2W * FOLFIRI (IV) Q2W
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Vinorelbine	* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Gemcitabine	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks
Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer	Vinorelbine	Trastuzumab (IV) - Q3W * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine twice every 3 weeks * Paclitaxel once every 3 weeks (Q3W) * Vinolrebine (IV) twice every 3 weeks

Primary Outcome Measures

Name	Time	Method
MBC substudy: Overall Response Rate	Approximately 6 months after the last participant is randomized	ORR per RECIST version 1.1 based on blinded independent central read (BICR), defined as a best overall response (BOR) of complete response (CR) or partial response (PR)
CRC substudy: Determine the safety and tolerability of evorpacept in combination with cetuximab and FOLFIRI	28 days from the first dose of evorpacept	Dose limiting toxicities for all participants enrolled in the dose escalation phase who received at least one dose of evorpacept and completed the DLT evaluation.
CRC substudy: Determine the MAD/MTD, the RP2D and recommended regimen	28 days from first dose of evorpacept	AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study drug in all treated participants

Secondary Outcome Measures

Name	Time	Method
MBC substudy: Assess secondary measures of efficacy	Approximately 6 months after the last participant is randomized	ORR based on Investigator assessment; CBR, DoR and PFS, using RECIST 1.1 based on BICR and Investigator assessment, and OS
MBC substudy: Evaluate the safety profile of evorpacept in combination with trastuzumab and each of the chemotherapy regimens	Enrollment to 28 days after the last administration of the study drug	AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity, and timing.
All substudies: Characterize single and multiple dose PK of evorpacept	Approximately 6 months after the last participant is randomized	Based on pharmacokinetic parameters of evorpacept such as Cmax, Tmax, AUC, CL and t1/2
All substudies: Evaluate the immunogenicity of evorpacept	Approximately 6 months after the last participant is randomized	Measured by presence of human serum ADA (anti-evorpacept antibodies)
CRC substudy: Evaluate the overall safety profile of evorpacept in combination with other agents	Enrollment to 28 days after the last administration of the study drug	Laboratory abnormalities as characterized by type, frequency, severity and timing for all enrolled participants who received at least one dose of evorpacept
CRC substudy: Evaluate the anti-tumor activity of evorpacept	Approximately 6 months after the last participant is randomized	Determined by ORR per Investigator Assessment using RECIST 1.1 and DCR by Investigator assessment per RECIST v1.1, DoR, PFS and OS in all enrolled participants who receive at least 1 dose any study drug and undergo at least one post-baseline disease assessment.

Trial Locations

Locations (1)

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States