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NCT04053205
An Multi-center, Open-label Phase Ib/II Study of Gentuximab Injection + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer to Evaluate Tolerability, Safety, Efficacy and Pharmacokinetics.
Phase 1/Phase 2 trial testing Gentuximab in Advanced Gastric or Gastroesophageal Junction Cancer in 76 participants. Completed in 20 September 2020.
1 June 2020
Quick facts
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 5 November 2019 |
| Primary completion | 1 June 2020 |
| Estimated completion | 20 September 2020 |
| Sites | 12 locations across China |
Drugs / interventions tested
- Gentuximab
- Paclitaxel — full drug profile →
Conditions studied
- Advanced Gastric or Gastroesophageal Junction Cancer — all drugs for Advanced Gastric or Gastroesophageal Junction Cancer →
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Gastric or Gastroesophageal Junction Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose-limiting toxicities (DLT)
Time frame: Up to 4 Weeks
Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol -
AEs or SAEs
Time frame: Baseline through Study Completion, about 24 weeks
Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Sponsor's own description
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04053205
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gentuximab
Trials testing the same drug.
- NCT05223595 — A Study of Gentuximab in Combination With Almonertinib in EGFR Mutation-positive Metastatic NSCLC · Phase 1 · unknown
Other Changchun GeneScience Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07534176 — To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . · Phase 1 · not yet recruiting
- NCT07476586 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants · Phase 1 · not yet recruiting
- NCT07491289 — GS1-144 in Participants With Hepatic Impairment and Healthy Female · Phase 1 · not yet recruiting
- NCT07537231 — A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Fe · Phase 1 · not yet recruiting
- NCT07366866 — A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults. · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04053205 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changchun GeneScience Pharmaceutical Co., Ltd.
- Last refreshed: 19 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04053205.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing