Advanced Solid MalignanciesPhase 1NCT02347228

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

A Phase 1 study testing OB318 capsule in people with Advanced Solid Malignancies, run by Oneness Biotech Co., Ltd. at 2 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Advanced Solid Malignancies
What is being tested?: OB318 capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesTaiwan
Study dates: 28 Aug 2020to 22 Nov 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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, at least one measurable untreated target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
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.

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

Who cannot join

Primary major surgery (of the brain, chest, abdomen and/or pelvis requiring general anesthesia) < 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 Antrodia cinnamomea and its related substances, including mannitol, gelucire, silicon dioxide and gelatin.

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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.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Tri-Service General Hospital
Taipei, 114
Taipei Medical University-Shuang Ho Hospital
Taipei

Other trials in Taiwan

About this study

Official title: 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

Conditions: Advanced Solid Malignancies
Being tested: OB318 capsule
Keywords: OB318, Advanced Solid Malignancies, Antrodia cinnamomea, Antrodia camphorata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OB318 capsuleDrug
Oral qd, at least 30 minutes before breakfast

Study groups in NCT02347228
Study group	Role	What they receive
OB318 capsule	Experimental	Not described Receives: Drug: OB318 capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 28 days

Secondary outcomes (27)

Changes in laboratory safety tests (hematology, biochemistry, urinalysis) from baseline
Laboratory safety tests will be performed at screening, baseline, Day 14 and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, lab tests will be done before each 28 days cycle.
Measured: up to 84 days
Incidence of Adverse Events (AEs)
Measured: up to 84 days
Incidence of Serious Adverse events (SAEs)
Measured: up to 84 days
Incidence of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase
Measured: up to 84 days
Characterization of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase
Measured: up to 84 days
Changes in physical examination from baseline
Physical examination will be performed at screening, baseline, and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, physical examination will be done at last day of each cycle.
Measured: up to 84 days
Changes in vital signs from baseline
Vital signs will be performed at each study visit.
Measured: up to 84 days
Changes from baseline in Electrocardiogram (ECG) results (QRS, QT, QTc, RR intervals)
Electrocardiogram (ECG) is conducted at screening, baseline, Day 14 and Day 28 for the dose escalation, and at the last follow-up visit. For the extension phase, ECG will be conducted at the same time.
Measured: up to 84 days
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of the
Imaging for tumor assessment will be made at screening, at the end of the treatment for the dose escalation and at the end of Cycle 2 for the extension phase.
Measured: up to 84 days
Pharmacokinetic parameters- Cmax
Measured: 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
Measured: 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 extrapolated to infinity
Measured: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-CL/F
Measured: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-Vz/F
Measured: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-Tmax
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Cmax,ss
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Cavg,ss
Measured: 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)
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- CLss/F
Measured: 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
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Tmax,ss
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- FI
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Rac
Measured: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202022 Nov 2024

First posted27 Jan 2015 (estimated)
Study start28 Aug 2020
Primary completion22 Nov 2024
Study completion22 Nov 2024

Why it stopped: This decision is based on a strategic company decision to discontinue development of this program as part of our portfolio prioritization.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347228
Sponsor's protocol ID: OB318CLCT01
Status last verified: Feb 2025
First submitted: 25 Dec 2014
Last updated: 10 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02347228
Acronym / sponsor ID: OB318CLCT01
Conditions: Advanced Solid Malignancies
Keywords: OB318, Advanced Solid Malignancies, Antrodia cinnamomea, Antrodia camphorata
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: This decision is based on a strategic company decision to discontinue development of this program as part of our portfolio prioritization.
Enrolment: 21 participants (actual)
Lead sponsor: Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Aug 2020 (actual)
Primary completion: 22 Nov 2024 (actual)
Study completion: 22 Nov 2024 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OB318 capsule	Experimental	Drug: OB318 capsule

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

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, at least one measurable untreated target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
Life expectancy ≥ 3 months.

Key exclusion criteria (11 listed)

Primary major surgery (of the brain, chest, abdomen and/or pelvis requiring general anesthesia) < 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OB318 capsuleOral qd, at least 30 minutes before breakfast	Drug	OB318 capsule

Primary outcome

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

27 secondary outcomes

Changes in laboratory safety tests (hematology, biochemistry, urinalysis) from baseline
Time frame: up to 84 days
Incidence of Adverse Events (AEs)
Time frame: up to 84 days
Incidence of Serious Adverse events (SAEs)
Time frame: up to 84 days
Incidence of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase
Time frame: up to 84 days
Characterization of toxicities ≥ grade 3, according to NCI-CTCAE version 4.03, related to OB318, during extension phase
Time frame: up to 84 days
Changes in physical examination from baseline
Time frame: up to 84 days
Changes in vital signs from baseline
Time frame: up to 84 days
Changes from baseline in Electrocardiogram (ECG) results (QRS, QT, QTc, RR intervals)
Time frame: up to 84 days
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of the
Time frame: up to 84 days
Pharmacokinetic parameters- Cmax
Time frame: 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
Time frame: 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 extrapolated to infinity
Time frame: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-CL/F
Time frame: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-Vz/F
Time frame: Day 1 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters-Tmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Cmax,ss
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Cavg,ss
Time frame: 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)
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- CLss/F
Time frame: 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
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Tmax,ss
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- FI
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318
Pharmacokinetic parameters- Rac
Time frame: Day 28 of Cycle 1 from the subjects with dose level 1, 2, 4, 6, 8, and 10 of OB318

Results and safety

The study was stopped early (reason given: This decision is based on a strategic company decision to discontinue development of this program as part of our portfolio prioritization.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.

Related trials for Advanced Solid Malignancies

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ching-Liang Ho principal investigator

Tri-Service General Hospital (TSGH)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OB318 capsule in people with Advanced Solid Malignancies, run by Oneness Biotech Co., Ltd. at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLTs) of OB318 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.