A Study of HB002.1T Plus Chemotherapy in Subjects With Solid Tumor

NCT04802980 | Unknown Phase 1

• 1 other identifier: HB002.1T-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 weeks

Secondary Outcomes (5)

• Immunogenicity of HB002.1T

  through study completion, up to 24 weeks

• overall response rate (ORR)

  through study completion, up to 24 weeks

• disease control rate (DCR)

  through study completion, up to 24 weeks

• Progression free survival (PFS)

  through study completion, up to 24 weeks

• duration of response (DOR)

  through study completion, up to 24 weeks

Study Arms (3)

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

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

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

Drug: HB002.1T; Drug: Gemcitabine; Drug: Cisplatin

Interventions

HB002.1T DRUG

HB002.1T is a vascular endothelial growth factor receptor decoy

HB002.1T + Gemcitabine + Cisplatin; HB002.1T + Oxaliplatin+ Capecitabine; HB002.1T + Paclitaxel + Carboplatin

Oxaliplatin DRUG

Oxaliplatin is an anti-tumor drug

HB002.1T + Oxaliplatin+ Capecitabine

Capecitabine DRUG

Capecitabine is an anti-tumor drug

HB002.1T + Oxaliplatin+ Capecitabine

Paclitaxel DRUG

Paclitaxel is an anti-tumor drug

HB002.1T + Paclitaxel + Carboplatin

Gemcitabine DRUG

Gemcitabine is an anti-tumor drug

HB002.1T + Gemcitabine + Cisplatin

Cisplatin DRUG

Cisplatin is an anti-tumor drug

HB002.1T + Gemcitabine + Cisplatin

Carboplatin DRUG

Carboplatin is an anti-tumor drug

HB002.1T + Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Capecitabine; Paclitaxel; Gemcitabine; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jin Li, Ph.D

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, Ph.D

CONTACT

86-21-38804518; tianyoulijin@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 17, 2021
• Study Start: April 28, 2020
• Primary Completion: July 15, 2023
• Study Completion: September 1, 2023
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)