Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with fluorouracil, leucovorin, and budigalimab in locally advanced/metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (a/m GEA).
Bibliographic record
Abstract
TPS4202 Background: The MET proto-oncogene and its receptor tyrosine kinase gene product (c-Met protein) are involved in normal cellular functions such as cell proliferation and differentiation but can be abnormally activated and upregulated in cancer to promote tumor growth. MET gene amplification and increased c-Met protein expression are associated with poor survival outcomes in gastric cancer. The antibody-drug conjugate Temab-A (ABBV-400) is composed of the c-Met–directed antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor. A phase 1 study (NCT05029882) investigating Temab-A monotherapy demonstrated manageable safety and encouraging efficacy in patients with previously treated, advanced GEA, with an objective response rate of 29% (12/42) and clinical benefit rate of 71% (30/42) (Strickler et al. Ann Oncol . 2024;35:1439P). This study evaluates Temab-A in combination with fluorouracil (5-FU), leucovorin/folinic acid (LV), and budigalimab (budi; a PD-1–blocking antibody). Methods: This multicenter,phase 2, open-label, randomized study (NCT06628310) will enroll ~180 adult patients with HER2-negative a/m GEA who have not received prior systemic therapy in the a/m setting, have not received a prior PD-(L)1 inhibitor, have Eastern Cooperative Oncology Group performance status 0–1, and have measurable disease per RECIST v1.1. Primary objectives of the study are to evaluate safety and tolerability, evaluate efficacy as measured by progression-free survival and objective response, and select the recommended phase 3 dose of Temab-A in combination with 5-FU, LV, and budi. Secondary objectives include assessment of dose-limiting toxicities (DLTs) in the dose-escalation stage, evaluation of pharmacokinetics, and further evaluation of efficacy measures (duration of response, disease control, and overall survival). The study consists of 2 stages: dose escalation and dose optimization. During BOIN-directed dose escalation, ~18 patients receive escalating doses of Temab-A administered once every 4 weeks (Q4W) in combination with fixed doses of 5-FU (2400 mg/m 2 Q2W), LV (400 mg/m 2 Q2W), and budi (500 mg Q4W). DLTs are assessed during the first 28-day cycle. During dose optimization, ~162 patients are randomized 1:1:1 to 1 of 2 selected doses of Temab-A in combination with 5-FU, LV, and budi or a control arm of FOLFOX + budi. Randomization is stratified by PD-L1 expression and primary tumor location. Treatment is administered until disease progression, intolerable toxicity, or other discontinuation criteria are met. Either archived formalin-fixed paraffin-embedded tissue or a fresh biopsy is required for biomarker research that will include evaluation of c-Met protein expression and MET genomic alterations. Clinical trial information: NCT06628310 .
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".