Solid TumorPhase 1NCT02414516

A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

A Phase 1 study testing OBP-801 in people with Solid Tumor, run by Oncolys BioPharma Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: OBP-801
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Aug 2019
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Patient Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

Histologically or cytologically confirmed metastatic or unresectable solid tumor.
Has failed treatment with all standard therapies for their malignancy.
Adequate Karnofsky Performance Status.
An expected survival of at least 3 months.
Adequate organ and bone marrow function.
Signed informed consent form for study participation prior to screening.

Patient Exclusion Criteria

Patients presenting with any of the following will be excluded in the study:

Clinically significant disease as defined by the protocol.
Surgical therapy or other therapies within period as defined by the protocol.
Any condition that will interfere with compliance with the protocol as determined by investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.

Conditions: Solid Tumor
Being tested: OBP-801
Keywords: HDAC, Epigenetic, Histone, Acetylation

What participants receive

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

OBP-801Drug
OBP-801 will be administered IV

Study groups in NCT02414516
Study group	Role	What they receive
OBP-801	Experimental	Not described Receives: Drug: OBP-801

What is being measured

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

Maximum Tolerated Dose
Measured: 6 weeks

Secondary outcomes (3)

Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2
Measured: 4 weeks
Objective Response (OR)
Measured: 22 weeks
Durability of Objective Response (DOR)
Measured: 22 weeks

Timeline

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

Mar 2015Aug 2019

First posted10 Apr 2015 (estimated)
Study startMar 2015
Primary completionJun 2019 (estimated)
Study completionAug 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies 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: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02414516
Sponsor's protocol ID: OBP-801-001
Status last verified: Mar 2019
First submitted: 23 Mar 2015
Last updated: 13 Mar 2019
Results posted: No
Data monitoring committee: No

Publications

Heath EI, Weise A, Vaishampayan U, Danforth D, Ungerleider RS, Urata Y. Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2022 Apr;40(2):300-307. doi: 10.1007/s10637-021-01180-9. Epub 2021 Oct 6.
PubMed 34613570

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

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
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02414516
Acronym / sponsor ID: OBP-801-001
Conditions: Solid Tumor
Keywords: HDAC, Epigenetic, Histone, Acetylation
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 17 participants (actual)
Lead sponsor: Oncolys BioPharma IncIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Jun 2019 (estimated)
Study completion: Aug 2019 (estimated)
First posted: 10 Apr 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.

This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.

Study design

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

Arm	Type	Receives
OBP-801	Experimental	Drug: OBP-801

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
OBP-801OBP-801 will be administered IV	Drug	OBP-801

Primary outcome

Maximum Tolerated Dose
Time frame: 6 weeks

3 secondary outcomes

Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2
Time frame: 4 weeks
Objective Response (OR)
Time frame: 22 weeks
Durability of Objective Response (DOR)
Time frame: 22 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
Derived from this study: PubMed 34613570Heath EI, Weise A, Vaishampayan U, Danforth D, Ungerleider RS, Urata Y. Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2022 Apr;40(2):300-307. doi: 10.1007/s10637-021-01180-9. Epub 2021 Oct 6.

Related trials for Solid Tumor

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
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OBP-801 in people with Solid Tumor, run by Oncolys BioPharma Inc at 1 site in United States.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Results are not available in the source record.

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?

Maximum Tolerated Dose (time frame: 6 weeks). 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 NCT02414516, which also lists 1 linked publication.

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 13 Mar 2019.