Advanced Gastric or Gastroesophageal Junction CancerPhase 1/2NCT04053205
A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
A Phase 1/2 study testing Gentuximab and Paclitaxel in people with Advanced Gastric or Gastroesophageal Junction Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric or Gastroesophageal Junction Cancer
- What is being tested?
- Gentuximab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 12 sitesChina
- Study dates
- 5 Nov 2019to 20 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Male or female. aged between 18 and 75 years
- Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
- A life expectancy of >3 months.
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- Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
- Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
- Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level> 1.5 × ULN.
- Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
- 24-hour urine protein quantitation is <1g（24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit）.
- Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Who cannot join
- Previously administrated with anti-angiogenic drugs or paclitaxel.
- Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Patients with previously confirmed malignant tumors.
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- History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening， or the investigator determines that there is a risk of bleeding.
- History of severe cardiovascular and cerebrovascular diseases.
- Subjects with confirmed brain tumor metastases，but subjects in steady situation can be enrolled.
- Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
- Thoracic，abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
- Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
- Active infections requiring systemic treatment, including but not limited to active tuberculosis.
- Using anticoagulation and antiplatelet drugs.
- Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
- Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
- Has known alcohol or drug dependency.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The First Hospital of Jilin University
Changchun, Jilin
Fujian Tumor Hospital
Fuzhou, Fujian
The Sixth Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Hangzhou, Zhejiang
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang
Jiangsu Province Hospital
Nanjing, Jiangsu
Shanghai East Hospital
Shanghai
Shanghai First People's Hospital
Shanghai
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: 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.
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.
Read the detailed description
The study includes dose-limiting toxicity （DLT）observing period and randomization period with two cohorts as low-dose group（Gentuximab Injection 8mg/kg+ paclitaxel） and high-dose group（Gentuximab Injection 12mg/kg+ paclitaxel）. During the study，the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients. DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period. PK were doing in part of subjects.
- Being tested
- Gentuximab, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentuximabDrug
Administered intravenously (IV)
PaclitaxelDrug
Administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| 1 Gentuximab+ Paclitaxel | Experimental | 8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15 Receives: Drug: Gentuximab; Drug: Paclitaxel |
| 2 Gentuximab+ Paclitaxel | Experimental | 12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15 Receives: Drug: Gentuximab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
Measured: Up to 4 Weeks
AEs or SAEs
Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Measured: Baseline through Study Completion, about 24 weeks
Secondary outcomes (8)
Objective response rate（ORR）
Proportion of Participants With CR and PR
Measured: Up to 6 cycles (28 days for every cycle)
Progression-free survival (PFS)
The time from randomization to the patient tumor progression or death.
Measured: Up to 6 cycles (28 days for every cycle)
Disease control rate (DCR)
Proportion of Participants With CR, PR and SD
Measured: Up to 6 cycles (28 days for every cycle)
Time-to-progress (TTP)
The time from randomization to the patient tumor progression.
Measured: Up to 6 cycles (28 days for every cycle)
Time-to-failure (TTF)
The time from randomization to the patient withdraw from the study.
Measured: Up to 6 cycles (28 days for every cycle)
Anti-drug antibody
Number of Participants With Anti-drug Antibodies
Measured: Up to 6 cycles (28 days for every cycle)
Pharmacokinetics Cmax
Maximum Concentration (Cmax)
Measured: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
Area Under the Concentration-Time Curve (AUC)
Measured: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start5 Nov 2019
- Primary completion1 Jun 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric or Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital, First Affiliated Hospital of Zhejiang University, Fujian Cancer Hospital, Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sixth Affiliated Hospital, Sun Yat-sen University, Tongji Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053205
- Sponsor's protocol ID
- GenSci 043 CT
- Status last verified
- May 2026
- First submitted
- 27 Jul 2019
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04053205
- Acronym / sponsor ID
- GenSci 043 CT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital, First Affiliated Hospital of Zhejiang University, Fujian Cancer Hospital, Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sixth Affiliated Hospital, Sun Yat-sen University, Tongji Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Zhengzhou University
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study includes dose-limiting toxicity （DLT）observing period and randomization period with two cohorts as low-dose group（Gentuximab Injection 8mg/kg+ paclitaxel） and high-dose group（Gentuximab Injection 12mg/kg+ paclitaxel）. During the study，the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients. DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period. PK were doing in part of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Gentuximab+ Paclitaxel | Experimental | Drug: Gentuximab, Drug: Paclitaxel8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15 |
| 2 Gentuximab+ Paclitaxel | Experimental | Drug: Gentuximab, Drug: Paclitaxel12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Male or female. aged between 18 and 75 years
- Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
Key exclusion criteria (18 listed)
- Previously administrated with anti-angiogenic drugs or paclitaxel.
- Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentuximabAdministered intravenously (IV) | Drug | 1 Gentuximab+ Paclitaxel, 2 Gentuximab+ Paclitaxel |
| PaclitaxelAdministered intravenously (IV) | Drug | 1 Gentuximab+ Paclitaxel, 2 Gentuximab+ Paclitaxel |
Primary outcome
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)
8 secondary outcomes
Objective response rate（ORR）
Time frame: Up to 6 cycles (28 days for every cycle)
Progression-free survival (PFS)
Time frame: Up to 6 cycles (28 days for every cycle)
Disease control rate (DCR)
Time frame: Up to 6 cycles (28 days for every cycle)
Time-to-progress (TTP)
Time frame: Up to 6 cycles (28 days for every cycle)
Time-to-failure (TTF)
Time frame: Up to 6 cycles (28 days for every cycle)
Anti-drug antibody
Time frame: Up to 6 cycles (28 days for every cycle)
Pharmacokinetics Cmax
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
Area Under the Concentration-Time Curve (AUC)
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gentuximab and Paclitaxel in people with Advanced Gastric or Gastroesophageal Junction Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: Up to 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.