Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies

Oneness Biotech

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: OB318 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02347228

OB318CLCT01

Details and patient eligibility

About

The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetics (PK), safety/ tolerability and preliminary efficacy of OB318 in patients with advanced solid malignancies.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients of age ≥20 years

2. Pathologically or cytologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective; the diagnosis of hepatocellular carcinoma (HCC) made according to the imaging specified in the American Association for the Study of Liver Diseases (AASLD) 2018 is acceptable.

3. Evaluable disease, either at least one measurable untreated target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria or measurable by informative tumor marker(s).

4. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.

5. Life expectancy ≥ 3 months.

6. If history of brain metastases treated with radiation therapy, radiation therapy is required to be completed at least 3 months prior to enrolment and metastasis achieve stable disease (SD) since radiation completion.

7. Must have recovered from toxicities of previous anti-cancer treatments to NCI-CTCAE grade 1 or lower, except for alopecia.

8. Laboratory values at screening of:

   • Absolute neutrophil count ≥ 1,500 /mm3;
   • Platelets ≥ 75,000 /mm3;
   • Hemoglobin (Hb) ≥ 8.5 g/dL;
   • Total bilirubin ≤2.0 mg/dL;
   • AST (SGOT) ≤ 3 × ULN (upper limit of normal);
   • ALT (SGPT) ≤ 3 × ULN;
   • Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥ 60 mL/min.

9. Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at screening, the following criteria are met:

   • Total bilirubin ≤2.0 mg/dL;
   • AST and ALT ≤ 5 × ULN;
   • Child-Pugh Class A;
   • Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.

10. Female patients must be either of non-childbearing potential, i.e. surgically sterilized or one year post-menopausal; or, if of childbearing potential, confirmed not pregnant at screening and must use adequate contraceptive precautions (as per investigator) during the entire treatment period of this study and for 6 months after exiting from the study.

11. Male patients with female partners of childbearing potential must be willing to use a reliable form of contraception (as per investigator), from screening until 6 months after exiting from the study.

12. Given signed and dated written informed consent and willing/able to comply with all protocol required visits/procedures

Exclusion criteria

1. Primary major surgery < 4 weeks prior to the planned first study treatment day.
2. Lactating or pregnant women or plans to be become pregnant.
3. Except for alopecia, any drug-related AE from any previous treatments not recovered to grade 1 or less prior to the planned first study treatment day.
4. With active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal diseases, active pulmonary diseases, or medical conditions that may significantly affect adequate absorption of investigational product, eg., bad nutrition, proteinuria, etc..
5. Previous malignancy, except for basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
6. Known allergic to OB318 or its formulation excipients.
7. History of autoimmune disease.
8. Taking anti-coagulant or anti-platelet drugs (eg aspirin, Coumadin, ginko, clopidogrel).
9. Use of any investigational agents or non-registered product within 4 weeks of baseline.
10. Known human immunodeficiency virus (HIV) positivity.
11. With conditions, judged by the investigator, as unsuitable for the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

OB318 capsule

Experimental group

Treatment:

Drug: OB318 capsule