Solid TumorPhase 1NCT04802980
A Study of HB002.1T Plus Chemotherapy in Subjects With Solid Tumor
A Phase 1 study testing HB002.1T, Oxaliplatin and Capecitabine in people with Solid Tumor, run by Huabo Biopharm Co., Ltd. at 1 site in China.
Trial summary
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HB002.1T, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2020to Sep 2023
- 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
- 18 years≤Age≤75 years
- Histologically or cytologically confirmed advanced malignant solid tumor , including gastric cancer, ovarian cancer, cervical cancer, head and neck cancer, lung cancer, biliary tract tumor, pancreatic cancer, bladder cancer and nasopharyngeal carcinoma (not limited to the above tumor types) . And be suitable for the treatment of HB0021.T combined with 3 different chemotherapy regimen assessed by the investigators.
- No prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration of HB002.1T. And no traditional herb medicines for anti-tumor within 2 weeks .
- No prior antiangiogenic therapy such as bevacizumab, ramucirumab, apatinib or regofinib, et al.
- At least one measurable tumor lesion as per RECIST criteria v1.1
- ECOG performance status of 0 or 1
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- Life expectancy of at least 12 weeks
- Meet following organ functions:
- Absolute neutrophil count ≥2.0 x 10^9/L(no Recombinant human granulocyte colony stimulating factor support therapy with 14 days)
- Hemoglobin ≥100g/L(no blood transfusion or erythropoietin support treatment was received within 14 days)
- Platelet count ≥100×10^9/L (No Recombinant human thrombopoietin and other supportive therapies within 14 days prior to screening phase)
- Serum creatinine≤1.5×ULN or creatinine clearance of≥60ml/min (based on the Cockcroft Gault formula).
- Serum total bilirubin≤1.5×ULN.
- ALT and AST ≤2.5×ULN, with the following exceptions: Patients with liver metastases assessed by investigators: AST and/or ALT≤5×ULN
- Blood potassium≥3.0 mmol/L, blood calcium≥2.0 mmol/L
- Prothrombin time (PT)≤1.2×ULN, partial prothrombin kinase time (APTT)≤1.2×ULN
- Urine protein < 1+showed by urine test paper, or urine protein <1g for 24 hours
- Previous treatment toxicity returned to grade 1 as per NCI CTCAE 5.0, with the following exceptions :Hair loss or other with no safety risk judged by investigators.
- Subjects of childbearing potential must be willing to take effective contraceptive measures throughout the study and for 3 months after the last dose of HB002.1T.And females must have a negative pregnancy test during the screening period .
- Ability to understand the patient information and informed consent form and signed and dated written informed consent form.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Confirmed active CNS metastasis and /or cancerous meningitis; For patients with stable clinical symptoms for brain metastasis for more than 3months can be enrolled.
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- History of organ transplantationHistory of severe allergy or known severe allergic reactions (greater than grade 3 in CTCAE V5.0) to macromolecular protein preparations / monoclonal antibodies and any components of the test drug;
- Have received other clinical trial drugs within 4 weeks before the first treatment of HB002.1T;
- Have undergone major surgery within 4 weeks prior to screening;
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- Have undergone minor surgical procedures (including catheterization, except for PICC) within 2 days prior to screening;
- Systolic blood pressure≥140mmHg and/or diastolic blood pressure≥90mmHg after antihypertensive treatment (one antihypertensive drug is allowed in the baseline period, and the compound preparation is recognized as two);
- An active infection requiring antibiotics treatment during the screening period, or an unexplained fever > 38.5 °C occurs before the first dose;
- Hemoptysis within 4 weeks before screening (defined as coughing with ≥1 teaspoon of blood), but do not rule out cough only with sputum or small blood clot;
- Suffering from the following serious complications:
- Prior arterial thromboembolic events, venous thrombosis great than grade 3 or higher in NCI CTCAE5.0
- Previous or current persistent bleeding or coagulation disorders
- Dominant jaundice and/or coagulopathy caused by abnormal liver function
- Chronic Obstructive Pulmonary Disease (COPD) or other respiratory illness requiring hospitalization within 4 weeks prior to screening;
- History of abdominal hernia, gastrointestinal perforation abscess or acute bleeding within 6 months prior to screening;
- Esophageal varices, unhealed ulcer, wounds or fractures within 6 months prior to screening;
- Active cardiovascular diseases including but not limited to transient ischemic attack (TIA), cerebral vascular accident (CVA), transmural Myocardial infarction), transmural myocardial infarction, myocardial infarction (MI), hypertensive crisis or encephalopathy within 6 months prior to screening;
- Gastrointestinal disorders or conditions that may cause gastrointestinal bleeding or perforation (e.g., duodenal ulcer, intestinal obstruction, acute Crohn's disease, ulcerative colitis, massive gastrectomy and small bowel resection). Patients with chronic Crohn's disease and ulcerative colitis (except those with total colectomy and rectal resection) should be excluded even in the inactive stage
- Patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome;
- Previous intestinal perforation and intestinal fistula, still not recover after surgical treatment
- Absorption of oral drug will be significantly affected assessed by investigators (Cohort1 only)
- Subjects who are in use of warfarin, heparin , aspirin (>325 mg/day) or other drugs known to inhibit platelet function within 10 days prior to the first study treatment;
- Subjects receiving dipyridamole, ticlopidine, clopidogrel or cilostazol treatment;
- Subjects with a clear history of neurological or dysfunction, such as poor adherence to epilepsy;
- Pregnant or nursing women;
- Any other reasons assessed by the investigator that are not suitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Jin Li, Ph.D, 86-21-38804518 ext. 22132, tianyoulijin@163.com
Jin Li, Ph.D
About this study
Official title: A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors.
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.
Read the detailed description
This study is a Phase1b, multicenter, open-label, dose-escalation and dose-expansion in selected solid tumor indications. There are two parts to this study: a dose-escalation part and a dose-expansion part. About 63-72 subjects is planned to recruit, 27~36 subjects (9~12 subjects each arm) will be recruited during dose-escalation period The sample size may vary depending on the DLT observed at each dose level. The conventional 3+3 design will be applied for dose escalation. This trial will evaluate two adaptive dose levels, 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs). Cohorts of 3 subjects with metastatic or locally advanced solid tumors will receive HB002.1T at escalating dose levels in combination with different chemotherapy regimens. After determination of the Maximum tolerated dose (MTD), another 12 patients in each of 3 cohorts will be added to determine the safety, tolerability, pharmacokinetic (PK), and clinical activity of HB002.1T.
- Conditions
- Solid Tumor
- Being tested
- HB002.1T, Oxaliplatin, Capecitabine, Paclitaxel, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB002.1TDrug
HB002.1T is a vascular endothelial growth factor receptor decoy
OxaliplatinDrug
Oxaliplatin is an anti-tumor drug
CapecitabineDrug
Capecitabine is an anti-tumor drug
PaclitaxelDrug
Paclitaxel is an anti-tumor drug
GemcitabineDrug
Gemcitabine is an anti-tumor drug
CisplatinDrug
Cisplatin is an anti-tumor drug
CarboplatinDrug
Carboplatin is an anti-tumor drug
| Study group | Role | What they receive |
|---|---|---|
| HB002.1T + Oxaliplatin+ Capecitabine | Experimental | 21-24 patients with advanced gastric cancer administeredHB002.1T+ Oxaliplatin+ Capecitabine combination every 3 weeks in a 21-day cycle, total 18cycles Receives: Drug: HB002.1T; Drug: Oxaliplatin; Drug: Capecitabine |
| HB002.1T + Paclitaxel + Carboplatin | Experimental | 21-24 patients with advanced ovarian cancer, cervical cancer, head and neck cancer or lung cancer (not limited to the above tumor types) administered HB002.1T + Paclitaxel + Carboplatin combination every 3 weeks in a 21-day cycle, total 18cycles Receives: Drug: HB002.1T; Drug: Paclitaxel; Drug: Carboplatin |
| HB002.1T + Gemcitabine + Cisplatin | Experimental | 21-24 patients with advanced biliary tract tumor, pancreatic cancer, bladder cancer or nasopharyngeal carcinoma (not limited to the above tumor types) administered HB002.1T + Gemcitabine + Cisplatin combination every 3 weeks in a 21-day cycle, total 18cycles Receives: Drug: HB002.1T; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Maximum Tolerated Dose (MTD) of HB002.1T
Will be determined by dose limiting toxicity. MTD defined as the highest dose level with no more than 1 patient with DLT out of 6 patients that are treated.
Measured: up to 3 weeks
Secondary outcomes (5)
Immunogenicity of HB002.1T
Assessed by Anti-drug Anti-body (ADA) Assay
Measured: through study completion, up to 24 weeks
overall response rate (ORR)
Measured: through study completion, up to 24 weeks
disease control rate (DCR)
Measured: through study completion, up to 24 weeks
Progression free survival (PFS)
Measured: through study completion, up to 24 weeks
duration of response (DOR)
Measured: through study completion, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start28 Apr 2020
- Primary completion15 Jul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Ph.D, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802980
- Sponsor's protocol ID
- HB002.1T-02
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT04802980
- Acronym / sponsor ID
- HB002.1T-02
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 Mar 2021 (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 objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.
Detailed description
This study is a Phase1b, multicenter, open-label, dose-escalation and dose-expansion in selected solid tumor indications. There are two parts to this study: a dose-escalation part and a dose-expansion part. About 63-72 subjects is planned to recruit, 27~36 subjects (9~12 subjects each arm) will be recruited during dose-escalation period The sample size may vary depending on the DLT observed at each dose level. The conventional 3+3 design will be applied for dose escalation. This trial will evaluate two adaptive dose levels, 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs). Cohorts of 3 subjects with metastatic or locally advanced solid tumors will receive HB002.1T at escalating dose levels in combination with different chemotherapy regimens. After determination of the Maximum tolerated dose (MTD), another 12 patients in each of 3 cohorts will be added to determine the safety, tolerability, pharmacokinetic (PK), and clinical activity of HB002.1T.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HB002.1T + Oxaliplatin+ Capecitabine | Experimental | Drug: HB002.1T, Drug: Oxaliplatin, Drug: Capecitabine21-24 patients with advanced gastric cancer administeredHB002.1T+ Oxaliplatin+ Capecitabine combination every 3 weeks in a 21-day cycle, total 18cycles |
| HB002.1T + Paclitaxel + Carboplatin | Experimental | Drug: HB002.1T, Drug: Paclitaxel, Drug: Carboplatin21-24 patients with advanced ovarian cancer, cervical cancer, head and neck cancer or lung cancer (not limited to the above tumor types) administered HB002.1T + Paclitaxel + Carboplatin combination every 3 weeks in a 21-day cycle, total 18cycles |
| HB002.1T + Gemcitabine + Cisplatin | Experimental | Drug: HB002.1T, Drug: Gemcitabine, Drug: Cisplatin21-24 patients with advanced biliary tract tumor, pancreatic cancer, bladder cancer or nasopharyngeal carcinoma (not limited to the above tumor types) administered HB002.1T + Gemcitabine + Cisplatin combination every 3 weeks in a 21-day cycle, total 18cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 18 years≤Age≤75 years
- Histologically or cytologically confirmed advanced malignant solid tumor , including gastric cancer, ovarian cancer, cervical cancer, head and neck cancer, lung cancer, biliary tract tumor, pancreatic cancer, bladder cancer and nasopharyngeal carcinoma (not limited to the above tumor types) . And be suitable for the treatment of HB0021.T combined with 3 different chemotherapy regimen assessed by the investigators.
- No prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first administration of HB002.1T. And no traditional herb medicines for anti-tumor within 2 weeks .
- No prior antiangiogenic therapy such as bevacizumab, ramucirumab, apatinib or regofinib, et al.
- At least one measurable tumor lesion as per RECIST criteria v1.1
Key exclusion criteria (27 listed)
- Patients who meet any of the following criteria will be excluded from study entry:
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 |
|---|---|---|
| HB002.1THB002.1T is a vascular endothelial growth factor receptor decoy | Drug | HB002.1T + Gemcitabine + Cisplatin, HB002.1T + Oxaliplatin+ Capecitabine, HB002.1T + Paclitaxel + Carboplatin |
| OxaliplatinOxaliplatin is an anti-tumor drug | Drug | HB002.1T + Oxaliplatin+ Capecitabine |
| CapecitabineCapecitabine is an anti-tumor drug | Drug | HB002.1T + Oxaliplatin+ Capecitabine |
| PaclitaxelPaclitaxel is an anti-tumor drug | Drug | HB002.1T + Paclitaxel + Carboplatin |
| GemcitabineGemcitabine is an anti-tumor drug | Drug | HB002.1T + Gemcitabine + Cisplatin |
| CisplatinCisplatin is an anti-tumor drug | Drug | HB002.1T + Gemcitabine + Cisplatin |
| CarboplatinCarboplatin is an anti-tumor drug | Drug | HB002.1T + Paclitaxel + Carboplatin |
Primary outcome
the Maximum Tolerated Dose (MTD) of HB002.1T
Time frame: up to 3 weeks
Will be determined by dose limiting toxicity. MTD defined as the highest dose level with no more than 1 patient with DLT out of 6 patients that are treated.
5 secondary outcomes
Immunogenicity of HB002.1T
Time frame: through study completion, up to 24 weeks
overall response rate (ORR)
Time frame: through study completion, up to 24 weeks
disease control rate (DCR)
Time frame: through study completion, up to 24 weeks
Progression free survival (PFS)
Time frame: through study completion, up to 24 weeks
duration of response (DOR)
Time frame: through study completion, up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Jin Li, Ph.D principal investigator
Shanghai East Hospital
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 HB002.1T, Oxaliplatin and Capecitabine in people with Solid Tumor, run by Huabo Biopharm Co., Ltd. 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 20 inclusion and 27 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 28 Jul 2021. 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?
Contact Jin Li, Ph.D (86-21-38804518 ext. 22132, tianyoulijin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Maximum Tolerated Dose (MTD) of HB002.1T (time frame: up to 3 weeks). 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 28 Jul 2021.