A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies

Oneness Biotech Co., Ltd.2 sites in 1 country30 target enrollmentSeptember 11, 2020

ConditionsAdvanced Solid Malignancies

InterventionsOB318 capsule

DrugsOB318 capsule

Overview

Phase: Phase 1
Intervention: OB318 capsule
Conditions: Advanced Solid Malignancies
Sponsor: Oneness Biotech Co., Ltd.
Enrollment: 30
Locations: 2
Primary Endpoint: Dose limiting toxicities (DLTs) of OB318
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2020

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oneness Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≤
•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;

Exclusion Criteria

•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.

Arms & Interventions

OB318 capsule

Intervention: OB318 capsule

Outcomes

Primary Outcomes

Dose limiting toxicities (DLTs) of OB318

Time Frame: 28 days

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.

Maximum tolerated dose (MTD) of OB318

Time Frame: 28 days

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

Secondary Outcomes

Pharmacokinetic parameters- FI(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Changes from baseline in Electrocardiogram (ECG) results (QRS, QT, QTc, RR intervals)(up to 84 days)
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of the(up to 84 days)
Pharmacokinetic parameters- Cmax(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- AUC from time zero to the last quantifiable concentration(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Changes in vital signs from baseline(up to 84 days)
Pharmacokinetic parameters- Tmax,ss(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
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)
Changes in physical examination from baseline(up to 84 days)
Pharmacokinetic parameters- Cmax,ss(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- Cavg,ss(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- CLss/F(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- Vz,ss/F(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- Rac(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- AUC from time zero extrapolated to infinity(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters-CL/F(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters-Vz/F(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters-Tmax(Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- Terminal elimination half-life(Day 1 and Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- Terminal elimination rate constant(Day 1 and Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters-Ctrough(Day 27 and Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318 ; Day 7 and Day 14 of Cycle additionally for dose level 1 only)
Pharmacokinetic parameters- Cmin,ss(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)
Pharmacokinetic parameters- AUC(0-24h)(Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318)