A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chemotherapy in patients with HER2/Neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.
Bibliographic record
Abstract
TPS176 Background: Gastric cancer is the 5th most frequently diagnosed cancer and the 3rd leading cause of cancer deaths. HER2/neu is overexpressed in 15% to 25% of patients with gastric cancer and associated with a poor prognosis. Monoclonal antibodies against HER2/neu have been shown to be effective but alternative treatments are needed due to cost and global availability issues. IMU-131 is a B-cell peptide vaccine composed of 3 B cell epitopes derived from the extracellular domain of HER2/neu. Polyclonal antibodies against IMU-131 peptides binding 3 separate regions (DIII, IV) of HER2/neu have been shown to elicit antitumor activity in vitro and a phase I study demonstrated safety and immunogenicity in Her-2 +/++ metastatic breast cancer patients. Fusion of the single peptides into a hybrid peptide conjugated to CRM197 in conjunction with the adjuvant Montanide (P467-CRM-Montanide) improved formulation and stability of the vaccine. With the present Phase 1b/2 trial performed in patients with HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma, we hypothesized that administration of IMU-131 in addition to chemotherapy is safe and immunogenic, and will prolong survival and may delay tumor progression and/or reduce tumor burden. Methods: This study is an international open-label multicenter study performed in 16 Asian and Eastern European sites with a maximum of 18 patients enrolled in Phase 1b. This dose escalation study is designed to assess safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. Each patient is administered three injections of IMU-131, at a single dose level on Days 0, 14, and 35, accompanied by chemotherapy cycles of cisplatin and 5-fluorouracil or capecitabine every 21 days. The RP2D will be evaluated in the dose expansion Phase 2 study with 68 patients being enrolled. Results: The study is ongoing with the completion of the phase 1b portion in 4Q18. Conclusions: No conclusions can be drawn at this time. Clinical trial information: NCT02795988.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".