Evorpacept treatment for advanced HER2+ gastric cancer
A Phase 2/3 Study of Evorpacept (ALX148) in Patients with Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
This study is testing if a new treatment combining Evorpacept with other medications can help adults with advanced HER2-positive gastric cancer who need more options after previous therapies.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ALX Oncology Inc. Industry-sponsored |
| Drugs / interventions | ramucirumab, chemotherapy, Trastuzumab |
| Locations | 83 sites (Anaheim, California and 82 other locations) |
| Trial ID | NCT05002127 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Evorpacept (ALX148) in combination with Trastuzumab, Ramucirumab, and Paclitaxel for patients with advanced HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma. It is a randomized, open-label Phase 2 and double-blind Phase 3 trial involving approximately 450 adult patients who have previously undergone HER2-directed therapy and chemotherapy. The study aims to determine the safety and efficacy of this combination therapy in patients who are suitable for second or third-line chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced or metastatic HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma who have progressed after prior HER2-directed therapy and chemotherapy.
Not a fit: Patients with symptomatic CNS metastases or those who have previously received anti-CD47 or anti-SIRPα agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced HER2+ gastric cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in HER2+ gastric cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line) * Adequate Bone Marrow Function. * Adequate Renal \& Liver Function. * Adequate Performance Status Exclusion Criteria: * Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. * Prior treatment with any anti-CD47 or anti-SIRPα agent. * Prior treatment with ramucirumab.
Where this trial is running
Anaheim, California and 82 other locations
- The Oncology Institute of Hope & Innovation — Anaheim, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- Icon Cancer Centre Southport — Southport, Queensland, Australia (Recruiting)
- Monash Medical Centre — Clayton, Victoria, Australia (Recruiting)
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (Recruiting)
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium (Recruiting)
- Centre Hospitalier Universitaire de Liège — Liège, Belgium (Recruiting)
- Fakultní Nemocnice Hradec Králové — Hradec Králové, Czechia (Recruiting)
- Fakultní Nemocnice Olomouc — Olomouc, Czechia (Recruiting)
- Vseobecna Fakultni Nemocnice v Praze — Prague, Czechia (Recruiting)
- Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz — Besançon, France (Recruiting)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (Recruiting)
- Hôpital Morvan — Brest, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Hôpital Privé Jean Mermoz — Lyon, France (Recruiting)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
- Hôpital Saint-Antoine — Paris, France (Recruiting)
- Hôpital Trousseau — Paris, France (Recruiting)
- Hôpital Rangueil — Toulouse, France (Recruiting)
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi — Catania, Italy (Recruiting)
- Azienda Ospedaliero - Universitaria Careggi — Florence, Italy (Recruiting)
- Fondazione IRCCS - Istituto Nazionale dei Tumori — Milano, Italy (Recruiting)
- Policlinico Universitario Campus Bio-Medico — Roma, Italy (Recruiting)
- Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia — Udine, Italy (Recruiting)
- National Cancer Center Hospital East — Chiba, Japan (Recruiting)
- Kyushu Cancer Center — Fukuoka, Japan (Recruiting)
- Gifu University Hospital — Gifu, Japan (Recruiting)
- Japanese Red Cross Kumamoto Hospital — Kumamoto, Japan (Recruiting)
- University Hospital Kyoto Prefectural University of Medicine — Kyoto, Japan (Recruiting)
- Nagasaki University Hospital — Nagasaki, Japan (Recruiting)
- Osaka Prefectural Hospital Organization - Osaka International Cancer Institute — Osaka, Japan (Recruiting)
- Kindai University Hospital — Osaka, Japan (Recruiting)
- Saitama Cancer Center — Saitama, Japan (Recruiting)
- Tohoku University Hospital — Sendai, Japan (Recruiting)
- Shizuoka Cancer Center — Shizuoka, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Japan (Recruiting)
- Cancer Institute Hospital of JFCR — Tokyo, Japan (Recruiting)
- Kanagawa Cancer Center — Yokohama, Japan (Recruiting)
- Oita University Hospital - Hasama Campus — Ōita, Japan (Recruiting)
- Inje University Haeundae Paik Hospital — Busan, Korea, Republic of (Recruiting)
- Dong-A University Hospital — Busan, Korea, Republic of (Recruiting)
- Pusan National University Hospital — Busan, Korea, Republic of (Recruiting)
- Yeungnam University Medical Center — Daegu, Korea, Republic of (Recruiting)
- Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
- Hallym University Sacred Heart Hospital — Dongan, Korea, Republic of (Recruiting)
- National Cancer Center - Korea — Goyang-si, Korea, Republic of (Recruiting)
- Jeonbuk National University Hospital — Jeonju, Korea, Republic of (Recruiting)
+33 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Philip Fanning, PhD
- Email: info@alxoncology.com
- Phone: 650-466-7125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.