Solid TumorsPhase 1NCT03503604
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors
A Phase 1 study testing hPV19 mAb, 5-Fluorouracil and Oxaliplatin in people with Solid Tumors, run by SuZhou Stainwei Biotech Inc. at 1 site in China.
Trial summary
hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- hPV19 mAb, 5-Fluorouracil and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Mar 2019
- Phase
- Phase 1
- 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
- Confirmed malignity
- Measurable disease
- Performance status 2 or less(ECOG)
- Life expectancy ≥3 months
Who cannot join
- hepatitis C virus (HCV), or HIV antibody positive
- Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
- Evidence of serious infection
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, MD,Phd, 86-13761222111, lijin@csco.org.cn
Jin Li, Professor
About this study
Official title: A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.
hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.
- Conditions
- Solid Tumors
- Being tested
- hPV19 mAb, 5-Fluorouracil, Oxaliplatin, Leucovorin, Paclitaxel
- Keywords
- mAb, VEGF, antibody, phase1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hPV19 mAbBiological
Also called anti-VEGF mAb
Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
hPV19 mAbBiological
Also called anti-VEGF mAb
Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
5-FluorouracilDrug
400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
OxaliplatinDrug
IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks
LeucovorinDrug
IV infusion, 400 mg/m2 every 2 weeks
PaclitaxelDrug
IV infusion, 175 mg/m2 every 3 weeks
CarboplatinDrug
IV infusion, AUC=6 every 3 weeks
GemcitabineDrug
IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks
CarboplatinDrug
IV infusion, AUC=4 every 3 weeks
IrinotecanDrug
IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin) Receives: Biological: hPV19 mAb; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin |
| group 2 | Experimental | hPV19 mAb plus paclitaxel/carboplatin Receives: Biological: hPV19 mAb; Drug: Paclitaxel; Drug: Carboplatin |
| group 3 | Experimental | hPV19 mAb plus gemcitabine/carboplatin Receives: Biological: hPV19 mAb; Drug: Gemcitabine; Drug: Carboplatin |
| group 4 | Experimental | hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin) Receives: Biological: hPV19 mAb; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period
DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03) with any one of the following:
- Grade 4 neutropenia ≥7 days; febrile neutropenia; grade 4 anemia; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding;
- ≥ grade 3 nonhematologic toxicity with the exception of nausea, vomiting, diarrhea, dehydration or electrolyte abnormalities that resolved to a lower grade with maximum supportive treatment within 3 days;
- ≥Grade 3 hypertension that cannot resolved to a lower grade with supportive treatment within 2 weeks or uncontrolled hypertension;
- Urine protein ≥3.5 grams/24 hours and cannot resolved to < 1.0 grams/24 hours within 2 weeks;
- Gastrointestinal perforation: symptoms, signs and imaging evidence of abdominal pain require surgical treatment;
- Grade 3 or 4 arterial thromboembolism, including stroke and myocardial infarction;
Measured: during the first 21 days
Number of Participants With hPV19 Drug-Related Adverse Events or Serious Adverse Events
Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to hPV19. Events related to chemotherapy were reported separately.
Measured: Baseline to the last dose plus 28 days.
Secondary outcomes (7)
Number of Participants With Serum Anti-hPV19 Antibodies (Immunogenicity)
Measured: before Single dose; Day 21 of 21-day DLT assessment period; Every 8 or 9 weeks after 21-day DLT assessment period.
Maximum Concentration (Cmax) of hPV19
Measured: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Area Under the Curve (AUC) of hPV19
Measured: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Half Life (t1/2) of hPV19
t1/2 is the time required for the plasma/serum concentration to decrease 50%
Measured: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Clearance (CL) of hPV19
Measured: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Steady State Volume of Distribution (Vss) of hPV19
Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum
Measured: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Best Overall Response [Anti-Tumor Activity of hPV19 Plus Chemotherapy]
Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria.
Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.
Measured: Up to six months after 1st treatment or until progression of disease (PD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuZhou Stainwei Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503604
- Sponsor's protocol ID
- STW201701B
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 20 Apr 2018
- 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 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.
- ClinicalTrials.gov ID
- NCT03503604
- Acronym / sponsor ID
- STW201701B
- Conditions
- Solid Tumors
- Keywords
- mAb, VEGF, antibody, phase1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- SuZhou Stainwei Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 20 Apr 2018 (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.
hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: hPV19 mAb, Drug: 5-Fluorouracil, Drug: Oxaliplatin, Drug: LeucovorinhPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin) |
| group 2 | Experimental | Biological: hPV19 mAb, Drug: Paclitaxel, Drug: CarboplatinhPV19 mAb plus paclitaxel/carboplatin |
| group 3 | Experimental | Biological: hPV19 mAb, Drug: Gemcitabine, Drug: CarboplatinhPV19 mAb plus gemcitabine/carboplatin |
| group 4 | Experimental | Biological: hPV19 mAb, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: IrinotecanhPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed malignity
- Measurable disease
- Performance status 2 or less(ECOG)
- Life expectancy ≥3 months
Key exclusion criteria (3 listed)
- hepatitis C virus (HCV), or HIV antibody positive
- Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
- Evidence of serious infection
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 |
|---|---|---|
| hPV19 mAbAlso: anti-VEGF mAbIntravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks | Biological | group 1, group 4 |
| hPV19 mAbAlso: anti-VEGF mAbIntravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks | Biological | group 2, group 3 |
| 5-Fluorouracil400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks | Drug | group 1, group 4 |
| OxaliplatinIV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks | Drug | group 1 |
| LeucovorinIV infusion, 400 mg/m2 every 2 weeks | Drug | group 1, group 4 |
| PaclitaxelIV infusion, 175 mg/m2 every 3 weeks | Drug | group 2 |
| CarboplatinIV infusion, AUC=6 every 3 weeks | Drug | group 2 |
| GemcitabineIV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks | Drug | group 3 |
| CarboplatinIV infusion, AUC=4 every 3 weeks | Drug | group 3 |
| IrinotecanIV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks | Drug | group 4 |
Primary outcome
Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period
Time frame: during the first 21 days
DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03) with any one of the following: 1. Grade 4 neutropenia ≥7 days; febrile neutropenia; grade 4 anemia; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding; 2. ≥ grade 3 nonhematologic toxicity with the exception of nausea, vomiting, diarrhea, dehydration or electrolyte abnormalities that resolved to a lower grade with maximum supportive treatment within 3 days; 3. ≥Grade 3 hypertension that cannot resolved to a lower grade with supportive treatment within 2 weeks or uncontrolled hypertension; 4. Urine protein ≥3.5 grams/24 hours and cannot resolved to < 1.0 grams/24 hours within 2 weeks; 5. Gastrointestinal perforation: symptoms, signs and imaging evidence of abdominal pain require surgical treatment; 6. Grade 3 or 4 arterial thromboembolism, including stroke and myocardial infarction;
Number of Participants With hPV19 Drug-Related Adverse Events or Serious Adverse Events
Time frame: Baseline to the last dose plus 28 days.
Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to hPV19. Events related to chemotherapy were reported separately.
7 secondary outcomes
Number of Participants With Serum Anti-hPV19 Antibodies (Immunogenicity)
Time frame: before Single dose; Day 21 of 21-day DLT assessment period; Every 8 or 9 weeks after 21-day DLT assessment period.
Maximum Concentration (Cmax) of hPV19
Time frame: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Area Under the Curve (AUC) of hPV19
Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Half Life (t1/2) of hPV19
Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Clearance (CL) of hPV19
Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Steady State Volume of Distribution (Vss) of hPV19
Time frame: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.
Best Overall Response [Anti-Tumor Activity of hPV19 Plus Chemotherapy]
Time frame: Up to six months after 1st treatment or until progression of disease (PD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hPV19 mAb, 5-Fluorouracil and Oxaliplatin in people with Solid Tumors, run by SuZhou Stainwei Biotech Inc. at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period (time frame: during the first 21 days). 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 20 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.