ArticleClinical cancer research : an official journal of the American Association for Cancer Research2019
Phase I Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-MDP Adjuvant in Patients with Advanced Solid Tumors.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like)Human Epidermal Growth Factor Receptor 2 (HER-2) B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors
First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors
Who cites it
43 citing papers in PubMed, 65 citations in OpenAlex.
- HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Trial
- A data-driven cartography of NSCLC vaccine research: Quantifying the paradigm shift toward immuno-oncology combination therapies.Human vaccines & immunotherapeutics · 2026Review
- B cells in cancer: functions, mechanisms and therapeutic advances.Signal transduction and targeted therapy · 2026Review
- Virus nanoparticle intratumoral vaccines for HER2Oncoimmunology · 2025Article
- Novel Chimeric CTLA-4 B-cell Epitope Peptide Vaccines Demonstrate Effective Antitumor Immunity with/without PD1/PDL1 Blockade in Multiple Syngeneic Murine Models of Breast and Colorectal Cancers.Molecular cancer therapeutics · 2025Article
- Revolutionizing Breast Cancer Therapeutics: Intersecting Frontiers of Precision Medicine, Nanotechnology, and Drug Delivery Innovations.Current treatment options in oncology · 2025Review
- Constructing the cure: engineering the next wave of antibody and cellular immune therapies.Journal for immunotherapy of cancer · 2025Review
- Therapeutic Cancer Vaccines in Colorectal Cancer: Platforms, Mechanisms, and Combinations.Cancers · 2025Article
- Innovative Peptide Therapeutics in the Pipeline: Transforming Cancer Detection and Treatment.International journal of molecular sciences · 2025Review
- MDSC depletion during immunization with heat-killedFrontiers in immunology · 2025Article
- Distinctive Immune Signatures Driven by Structural Alterations in Desmuramylpeptide NOD2 Agonists.Journal of medicinal chemistry · 2024Article
- Emerging treatments in HER2-positive advanced breast cancer: Keep raising the bar.Cell reports. Medicine · 2024Review
- Update on current and new potential immunotherapies in breast cancer, from bench to bedside.Frontiers in immunology · 2024Review
- Standard-of-Care Treatment for HER2+ Metastatic Breast Cancer and Emerging Therapeutic Options.Breast cancer : basic and clinical research · 2024Review
- Recent advances and applications of peptide-agent conjugates for targeting tumor cells.Journal of cancer research and clinical oncology · 2023Review
- Cancer Vaccines: From the State of the Art to the Most Promising Frontiers in the Treatment of Colorectal Cancer.Pharmaceutics · 2023Review
- PDAC, the Influencer Cancer: Cross-Talk with Tumor Microenvironment and Connected Potential Therapy Strategies.Cancers · 2023Review
- Highlights into historical and current immune interventions for cancer.International immunopharmacology · 2023Review
- Immunotherapies against HER2-Positive Breast Cancer.Cancers · 2023Review
- Targeting HER2-positive breast cancer: advances and future directions.Nature reviews. Drug discovery · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
purposeThis first-in-human phase I study (NCT01417546) evaluated the safety profile, optimal immunologic/biological dose (OID/OBD), and immunogenicity of the combination of two peptide B-cell epitope vaccines engineered to represent the trastuzumab- and pertuzumab-binding sites. Although trastuzumab and pertuzumab have been approved for clinical use, patients often develop resistance to these therapies. We have advanced a new paradigm in immunotherapy that focuses on humoral responses based on conformational B-cell epitope vaccines. PATIENTS AND
methodsThe vaccine is comprised of two chimeric HER-2 B-cell peptide vaccines incorporating a "promiscuous T-cell epitope." Patients were immunized with the vaccine constructs emulsified with nor-muramyl-dipeptide adjuvant in a water-in-oil Montanide ISA 720VG vehicle. Eligible patients with metastatic and/or recurrent solid tumors received three inoculations every 3 weeks.
resultsForty-nine patients with a median of 4 prior lines of chemotherapy received at least 1 vaccination. Twenty-eight patients completed the 3 vaccination regimens. Six patients received 1 six-month boost after the regimen, and one patient received 7 six-month boosts. No serious adverse reactions or dose-limiting toxicities were observed. The vaccine was well tolerated with dose level 2 as the recommended phase II dose. The most common related toxicity in all patients was injection-site reactions (24%). Two patients had a partial response, 14 had stable disease, and 19 had progressive disease.
conclusionsThe study vaccine is safe, exhibits antitumor activity, and shows preliminary indication that peptide vaccination may avoid therapeutic resistance and offer a promising alternative to monoclonal antibody therapies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.