Clinical trial · Interventional
ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.
A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer (GC) | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASKB589 +CAPOX+Sintilimab/Tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASKB589 +CAPOX+Sintilimab/Tislelizumab
- description
- Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab/Tislelizumab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years. ASKB589 is administered intravenously at a fixed dose. the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
- interventionNames
- Drug: ASKB589 +CAPOX+Sintilimab/Tislelizumab
Primary outcomes (4)
- measure
- Number of participants with adverse events as assessed by CTCAE v5.0
- timeFrame
- up to 21 days following last dose
- description
- An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy. 2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment. 3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory 4. ECOG performance status 0-1. 5. The results of the laboratory tests must meet all criteria 6. Life expectancy of at least 3 months. Exclusion Criteria: 1. Known active central nervous system metastasis or suspected cancerous meningitis; 2. There are moderate to large amounts of abdominal and pleural fluid. 3. The presence of clinically uncontrollable third interspace fluid; 4. Patients with any other malignant tumors within the past 5 years. 5. Applicable to anti-HER-2 drug therapy; 6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past; 7. Patients have received antitumor therapy during the first 4 weeks before study drug use; 8. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
References
Publications (0)
Data not yet available