Overview

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

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Huabo Biopharm Co., Ltd.
Treatments:
Capecitabine
Carboplatin
Gemcitabine
Oxaliplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. 18 years≤Age≤75 years

2. 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.

3. 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 .

4. No prior antiangiogenic therapy such as bevacizumab, ramucirumab, apatinib or
regofinib, et al.

5. At least one measurable tumor lesion as per RECIST criteria v1.1

6. ECOG performance status of 0 or 1

7. Life expectancy of at least 12 weeks

8. Meet following organ functions:

1. Absolute neutrophil count ≥2.0 x 10^9/L(no Recombinant human granulocyte colony
stimulating factor support therapy with 14 days)

2. Hemoglobin ≥100g/L(no blood transfusion or erythropoietin support treatment was
received within 14 days)

3. Platelet count ≥100×10^9/L (No Recombinant human thrombopoietin and other
supportive therapies within 14 days prior to screening phase)

4. Serum creatinine≤1.5×ULN or creatinine clearance of≥60ml/min (based on the
Cockcroft Gault formula).

5. Serum total bilirubin≤1.5×ULN.

6. ALT and AST ≤2.5×ULN, with the following exceptions: Patients with liver
metastases assessed by investigators: AST and/or ALT≤5×ULN

7. Blood potassium≥3.0 mmol/L, blood calcium≥2.0 mmol/L

8. Prothrombin time (PT)≤1.2×ULN, partial prothrombin kinase time (APTT)≤1.2×ULN

9. Urine protein < 1+showed by urine test paper, or urine protein <1g for 24 hours

9. 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.

10. 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 .

11. Ability to understand the patient information and informed consent form and signed and
dated written informed consent form.

Exclusion Criteria:

- Patients who meet any of the following criteria will be excluded from study entry:

1. Confirmed active CNS metastasis and /or cancerous meningitis; For patients with
stable clinical symptoms for brain metastasis for more than 3months can be
enrolled.

2. Positive test for hepatitis B, hepatitis C, or HIV at screening.

3. 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;

4. Have received other clinical trial drugs within 4 weeks before the first
treatment of HB002.1T;

5. Have undergone major surgery within 4 weeks prior to screening;

6. Have undergone minor surgical procedures (including catheterization, except for
PICC) within 2 days prior to screening;

7. 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);

8. An active infection requiring antibiotics treatment during the screening period,
or an unexplained fever > 38.5 °C occurs before the first dose;

9. 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;

10. Suffering from the following serious complications:

1. Prior arterial thromboembolic events, venous thrombosis great than grade 3
or higher in NCI CTCAE5.0

2. Previous or current persistent bleeding or coagulation disorders

3. Dominant jaundice and/or coagulopathy caused by abnormal liver function

4. Chronic Obstructive Pulmonary Disease (COPD) or other respiratory illness
requiring hospitalization within 4 weeks prior to screening;

5. History of abdominal hernia, gastrointestinal perforation abscess or acute
bleeding within 6 months prior to screening;

6. Esophageal varices, unhealed ulcer, wounds or fractures within 6 months
prior to screening;

7. 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;

8. 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

9. Patients with hereditary nonpolyposis colorectal cancer or familial
adenomatous polyposis syndrome;

10. Previous intestinal perforation and intestinal fistula, still not recover
after surgical treatment

11. Absorption of oral drug will be significantly affected assessed by
investigators (Cohort1 only)

11. 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;

12. Subjects receiving dipyridamole, ticlopidine, clopidogrel or cilostazol
treatment;

13. Subjects with a clear history of neurological or dysfunction, such as poor
adherence to epilepsy;

14. Pregnant or nursing women;

15. Any other reasons assessed by the investigator that are not suitable for
participation in the trial.