420 Participants NeededMy employer runs this trial

DS3790a for Blood Cancers

Recruiting at 6 trial locations
DS
Overseen ByDaiichi Sankyo Contact for Clinical Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Daiichi Sankyo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called DS3790a for people with blood cancers, focusing on its safety and effectiveness. Participants will receive either DS3790a alone or in combination with other treatments to determine which option is more effective. Individuals living with blood cancer who have not undergone a bone marrow or organ transplant are likely suitable candidates for this trial. As a Phase 1/Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications, but it mentions an 'inadequate washout period' as an exclusion criterion, which suggests that some medications might need to be stopped before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DS3790a is under careful study for safety in people with blood cancers. This treatment is an antibody-drug conjugate (ADC) that targets cancer cells and delivers a drug to destroy them. In current studies, researchers look for side effects, determine safe dosage levels, and check for any serious issues.

Ongoing trials continue to collect safety information. These trials are in the early stages, focusing on whether DS3790a is safe and how the body reacts to it. Researchers are also assessing how well participants tolerate the treatment.

Some similar treatments have shown promising results with manageable side effects, but each treatment is unique. As more information becomes available, researchers will gain a better understanding of DS3790a's safety and effectiveness. Participants in these studies provide essential information about the treatment's safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about DS3790a for treating blood cancers because it offers a novel approach compared to standard options like chemotherapy, immunotherapy, or targeted therapies. Unlike these existing treatments, DS3790a works by a unique mechanism, potentially targeting cancer cells more precisely and reducing damage to healthy cells. Moreover, the flexibility of DS3790a to be used both as a monotherapy and in combination with other regimens could lead to more personalized and effective treatment plans for patients. This innovative approach might improve outcomes and reduce side effects, which are significant issues with current treatments.

What evidence suggests that this trial's treatments could be effective for blood cancers?

Research has shown that DS3790a targets a protein called CD37, found on certain blood cancer cells. This protein aids in the survival and growth of cancer cells. DS3790a is designed to attach to these cells and deliver a toxic substance to kill them. Depending on the study arm, participants in this trial may receive DS3790a as a monotherapy or in combination with other treatments. Early studies suggest that DS3790a may help reduce the number of cancer cells in some patients with blood cancers. Although data remains limited, these early findings offer hope that DS3790a could become an effective treatment option.12456

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain types of blood cancers who have a life expectancy of at least 3 months, good organ and heart function, and are able to follow study procedures. People can't join if they recently had a stroke or transplant, have active infections like HIV or hepatitis, severe lung or heart issues, brain cancer spread, or unresolved side effects from past treatments.

Inclusion Criteria

Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions
I am 18 years old or older.
Sign and date the ICF prior to the start of any trial-specific procedures
See 8 more

Exclusion Criteria

I have had a stem cell transplant from a donor.
Inadequate washout period before initiation of trial intervention as specified in the protocol
I have not had a stroke, mini-stroke, or arterial blood clot in the past 6 months.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

Participants receive DS3790a monotherapy to determine the optimal dose

12 weeks
Weekly visits (in-person)

Monotherapy Dose Expansion

Participants receive DS3790a monotherapy at the determined optimal dose

16 weeks
Bi-weekly visits (in-person)

Combination Dose-escalation

Participants receive DS3790a monotherapy and selected combination regimen

16 weeks
Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Combination drug
  • DS3790a

Trial Overview

The study is testing the safety and early effectiveness of a new drug called DS3790a alone and in combination with other drugs in people with blood cancers. Participants will receive either DS3790a by itself or together with other medications to see how their bodies respond.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Active Control

Group I: Monotherapy Dose Expansion PhaseExperimental Treatment1 Intervention
Group II: Monotherapy Dose Escalation PhaseExperimental Treatment1 Intervention
Group III: Cohort B Randomization/Optimization PhaseExperimental Treatment2 Interventions
Group IV: Cohort B Combination Dose-escalation PhaseExperimental Treatment2 Interventions
Group V: Cohort A Randomization/Optimization PhaseExperimental Treatment2 Interventions
Group VI: Cohort A Phase 2Experimental Treatment2 Interventions
Group VII: Cohort A Combination Dose-escalation PhaseExperimental Treatment2 Interventions
Group VIII: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

NCT07220616 | A First-in-Human Trial of DS3790a in ...

DS3790a may be effective in the treatment of patients with hematological malignancies. The primary objective of this study will assess the safety and ...

A Study of DS3790a in People With a Hematologic ...

Full Title A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC targeting CD37, for Hematological Malignancies ...

DS3790 Enters Clinical Development as First DXd ADC in ...

“DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to ...

DS3790a Clinical Trial for Blood Cancers: Phase 1/2 Study of Novel ...

This clinical trial represents an important step forward in developing new treatment options for patients with hematological malignancies (blood cancers).

Initiation of Phase 1/2 Trial Marks a Strategic Shift in ...

The open-label, multicenter study is designed to assess the safety, tolerability, and preliminary efficacy of DS3790 in this patient population, ...

A First-in-Human Trial of DS3790a in Participants With ...

This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination ...