Advanced Solid TumorPhase 1NCT02076451

Open-label Study of DS-8273a to Assess Its Safety and Tolerability, and Assess Its Pharmacokinetic and Pharmacodynamic Properties in Subjects With Advanced Solid Tumors or Lymphomas

A Phase 1 study testing DS-8273a in people with Advanced Solid Tumor and Lymphoma, run by Daiichi Sankyo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability, identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its properties in subjects with advanced solid tumors or lymphomas. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor, Lymphoma
What is being tested?: DS-8273a
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Dec 2015
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

Who may be able to join

Has a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, and for whom no standard treatment is available.
Man or woman >= 18 years old.
Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Has adequate bone marrow function, defined as: Platelet count >= 100 X 10*9/L Hemoglobin level >= 9.0 g/dL Absolute neutrophil count >= 1.5 x 10*9/L
Has adequate renal function, defined as: Creatinine clearance >= 60 mL/minute, as calculated using the modified Cockroft Gault equation, ([{140 - age in years} × {actual weight in kg}] divided by [{72 × serum creatinine in mg/dL} multiplied by 0.85 if female]), OR creatinine <= 1.5 X upper limit of normal (ULN)
Has adequate hepatic function, defined as: AST/ALT <= 3 X ULN (if liver metastases are present, <= 5 X ULN) Bilirubin <= 1.5 X ULN

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Has adequate blood clotting function, defined as: International normalized ratio and activated partial thromboplastin time <= 1.5 X ULN
Subject should be able to provide written informed consent and comply with protocol visits and procedures.
Subject (male and female) of childbearing/ reproductive potential must agree to use double barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug.
Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Institutional Review Board-approved Informed Consent Form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.
Is willing to provide pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing a fresh tumor biopsy sample is optional.
Following treatment-free period prior to enrollment to the study: i)Surgery: 4 weeks for major surgery (e.g., laparotomy and thoracotomy); 2 weeks for less extensive surgery (e.g., colostomy) ii)Radiation: 4 weeks (2 weeks for palliative irradiation to bone metastases [except for pelvic irradiation], and brain metastasis) iii) Chemotherapy (including systemic treatment with anticancer therapy and retinoid therapy): 3 weeks (6 weeks for nitrosourea antineoplastic agent and mitomycin C) iv) Antibody-based therapy: 4 weeks v) Small molecule targeted agents: If myelosuppression is not expected, 2 weeks or 5 half-lives, whichever is longer; otherwise, 3 weeks vi) Hormonal treatment: 3 weeks. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment. vii) Pleurodesis: 2 weeks

Who cannot join

Has a history of primary central nervous system malignancy.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.
Has received an allogeneic bone marrow or allogeneic stem cell transplant.
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy).
Has unresolved toxicities from prior anti-cancer therapies, defined as toxicities (chemotherapy, hormonal treatment, radiation, and/or surgery) not yet resolved to NCI-CTCAE, v4, Grade <= 1 or baseline; other than alopecia, skin toxicity (Grade 1), according to NCI-CTCAE, v4. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (e.g., Grade 2 chemotherapy-induced peripheral neuropathy).

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Had an autologous transplant within 3 months of starting study drug treatment.
Participated in a therapeutic clinical study within 3 weeks (2 weeks or 5 half-lives, whichever is longer, for small-molecule targeted agents) before study drug treatment, or current participation in other therapeutic investigational procedures.
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 ms for males and > 470 ms for females based on triplicate electrocardiogram (ECG).
Pregnant or breastfeeding.
Substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
Prior treatment with a human DR5 agonist.
Life expectancy < 3 months in the opinion of the Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

Sarah Cannon Research Institute / Tennesee Oncology
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: PHASE 1, OPEN-LABEL STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF DS-8273A IN SUBJECTS WITH ADVANCED SOLID TUMORS OR LYMPHOMAS

Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose Expansion) in subjects with solid tumors or lymphomas.

Conditions: Advanced Solid Tumor, Lymphoma
Being tested: DS-8273a
Medical subject headings: Lymphoma

What participants receive

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

DS-8273aDrug
DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks

Study groups in NCT02076451
Study group	Role	What they receive
2 mg/kg DS-8273a	Experimental	2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks). Receives: Drug: DS-8273a
8 mg/kg DS-8273a	Experimental	2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks). Receives: Drug: DS-8273a
16 mg/kg of DS-8273a	Experimental	2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks). Receives: Drug: DS-8273a
24 mg/kg of DS-8273a	Experimental	2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks). Receives: Drug: DS-8273a

What is being measured

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

number of adverse events
To assess the safety and tolerability of DS 8273a in subjects with advanced solid tumors or lymphomas who have relapsed from or are refractory to standard treatment and for whom no standard treatment is available.
Measured: 21 days
maximum tolerated dose
To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD), and tentative recommended Phase 2 dose (RP2D) of DS-8273a in subjects with advanced solid tumors or lymphomas.
Measured: 21 days

Secondary outcomes (3)

tumor response
To evaluate the tumor response to DS-8273a using corresponding standard response criteria, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or revised International Working Group (IWG) criteria for lymphoma, if applicable.
Measured: 21 days
incidence of human anti-human antibody (HAHA) formation
evaluate the incidence of human anti-human antibody (HAHA) formation
Measured: 21 days
determine the pharmacokinetics of DS-8273a
determine the pharmacokinetics of DS-8273; area under the concentration versus-time curve [AUC], maximum [peak] observed concentration in plasma [Cmax], time of maximum observed concentration [tmax], terminal elimination half-life t1/2.
Measured: 21 days

Timeline

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

Feb 2014Dec 2015

First posted3 Mar 2014 (estimated)
Study startFeb 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02076451
Sponsor's protocol ID: DS8273-A-U101
Status last verified: Feb 2016
First submitted: 25 Feb 2014
Last updated: 12 Feb 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PHASE 1, OPEN-LABEL STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF DS-8273A IN SUBJECTS WITH ADVANCED SOLID TUMORS OR LYMPHOMAS
ClinicalTrials.gov ID: NCT02076451
Acronym / sponsor ID: DS8273-A-U101
Conditions: Advanced Solid Tumor, Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 3 Mar 2014 (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.

Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose Expansion) in subjects with solid tumors or lymphomas.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
2 mg/kg DS-8273a	Experimental	Drug: DS-8273a2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks).
8 mg/kg DS-8273a	Experimental	Drug: DS-8273a2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks).
16 mg/kg of DS-8273a	Experimental	Drug: DS-8273a2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks).
24 mg/kg of DS-8273a	Experimental	Drug: DS-8273a2 mg/kg, 8 mg/kg, 16 mg/kg, and 24 mg/kg of DS-8273a; DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks).

Who may qualify

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

Key inclusion criteria (12 listed)

Has a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, and for whom no standard treatment is available.
Man or woman >= 18 years old.
Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Has adequate bone marrow function, defined as: Platelet count >= 100 X 10*9/L Hemoglobin level >= 9.0 g/dL Absolute neutrophil count >= 1.5 x 10*9/L
Has adequate renal function, defined as: Creatinine clearance >= 60 mL/minute, as calculated using the modified Cockroft Gault equation, ([{140 - age in years} × {actual weight in kg}] divided by [{72 × serum creatinine in mg/dL} multiplied by 0.85 if female]), OR creatinine <= 1.5 X upper limit of normal (ULN)

Key exclusion criteria (13 listed)

Has a history of primary central nervous system malignancy.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.
Has received an allogeneic bone marrow or allogeneic stem cell transplant.
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy).

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
DS-8273aDS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks	Drug	16 mg/kg of DS-8273a, 2 mg/kg DS-8273a, 24 mg/kg of DS-8273a, 8 mg/kg DS-8273a

Primary outcome

number of adverse events
Time frame: 21 days
To assess the safety and tolerability of DS 8273a in subjects with advanced solid tumors or lymphomas who have relapsed from or are refractory to standard treatment and for whom no standard treatment is available.
maximum tolerated dose
Time frame: 21 days
To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD), and tentative recommended Phase 2 dose (RP2D) of DS-8273a in subjects with advanced solid tumors or lymphomas.

3 secondary outcomes

tumor response
Time frame: 21 days
incidence of human anti-human antibody (HAHA) formation
Time frame: 21 days
determine the pharmacokinetics of DS-8273a
Time frame: 21 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Advanced 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
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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 DS-8273a in people with Advanced Solid Tumor and Lymphoma, run by Daiichi Sankyo 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?

The sponsor lists 12 inclusion and 13 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: finished, as of the sponsor's last update on 12 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

number of adverse events (time frame: 21 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 NCT02076451.

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 12 Feb 2019.