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

NCT02347228 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: OB318CLCT01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Solid Malignancies

Keywords

OB318; Advanced Solid Malignancies; Antrodia cinnamomea; Antrodia camphorata

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs) of OB318

  NOTE: DLT is defined as any grade 3 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product OB318 and will be observed during the 4 weeks of treatment for patients in the dose escalation phase.

  28 days

• Maximum tolerated dose (MTD) of OB318

  NOTE:- MTD is defined as the prior dose level below the dose level at which 2/3 or 2/6 subjects suffer dose limiting toxicity (DLT) in the dose escalation phase

  28 days

Secondary Outcomes (27)

• Changes in laboratory safety tests (hematology, biochemistry, urinalysis) from baseline

  up to 84 days

• Incidence of Adverse Events (AEs)

  up to 84 days

• Incidence of Serious Adverse events (SAEs)

  up to 84 days

• Incidence of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase

  up to 84 days

• Characterization of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase

  up to 84 days

Study Arms (1)

OB318 capsule

EXPERIMENTAL

Drug: OB318 capsule

Interventions

OB318 capsule DRUG

Oral qd, at least 30 minutes before breakfast

OB318 capsule

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of age ≥20 years
• 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.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
• Life expectancy ≥ 3 months.
• 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.
• Must have recovered from toxicities of previous anti-cancer treatments to NCI-CTCAE grade 1 or lower, except for alopecia.
• 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.

You may not qualify if:

• Primary major surgery \< 4 weeks prior to the planned first study treatment day.
• Lactating or pregnant women or plans to be become pregnant.
• 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.
• 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..
• 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.
• Known allergic to OB318 or its formulation excipients.
• History of autoimmune disease.
• Taking anti-coagulant or anti-platelet drugs (eg aspirin, Coumadin, ginko, clopidogrel).
• Use of any investigational agents or non-registered product within 4 weeks of baseline.
• Known human immunodeficiency virus (HIV) positivity.
• With conditions, judged by the investigator, as unsuitable for the study.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (2)

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Ching-Liang Ho

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciao Hong

CONTACT

+886-2-2703-1098; Ciao.Hong@onenessbio.com.tw

Lisa Liang

CONTACT

+886-2-2703-1098; Lisa.Liang@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: January 27, 2015
• Study Start: September 11, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2023-03

Locations

TW (2)