DS-1055a for Cancer

Not currently recruiting at 7 trial locations

Overseen By (US sites) Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo Co., Ltd.

Disqualifiers: Second malignancy, ILD, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of a new drug, DS-1055a, for individuals with certain advanced solid tumors, such as head and neck, stomach, esophageal, lung cancer, or melanoma. It targets those whose cancer has returned or has not responded to other treatments. Participants will receive increasing doses of the drug to identify the safest dose. This trial may suit individuals with these cancers who have exhausted other options and are physically able to participate. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that DS-1055a is likely to be safe for humans?

Research shows that DS-1055a is a new treatment being tested for safety and tolerability in individuals with advanced cancers. In studies with specially modified mice, DS-1055a demonstrated strong effects against tumors, suggesting promise for human use. However, as a Phase 1 trial, this marks the first test of the treatment in humans. Phase 1 trials primarily focus on ensuring safety and determining the correct dosage. Detailed safety information in humans is still being gathered. Participants in the trial will help researchers understand how well people tolerate DS-1055a and identify any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DS-1055a because it represents a new approach to treating cancer. Unlike traditional cancer treatments like chemotherapy, which attack rapidly dividing cells in general, DS-1055a is designed to target specific cancer pathways, potentially offering a more precise attack on cancer cells while sparing healthy ones. This targeted mechanism could lead to fewer side effects and improved effectiveness. Additionally, the dose escalation approach in its trials aims to find the optimal balance between safety and efficacy, making it a promising candidate for future cancer therapies.

What evidence suggests that DS-1055a might be an effective treatment for cancer?

Research has shown that DS-1055a is a promising new cancer treatment. This drug targets Treg cells, a type of immune cell that usually helps control the immune system. DS-1055a reduces the number of these cells in the tumor area, potentially enhancing the body's ability to fight cancer. Studies have found that DS-1055a can strengthen the immune system's capacity to attack cancer cells. Early results demonstrated strong anti-cancer effects in human tests. Although more research is needed, these initial findings suggest that DS-1055a could effectively treat some advanced cancers. ^{2 4 6 7 8}

Who Is on the Research Team?

Clinical Study Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors that have relapsed or are not responding to treatment, and for which there is no standard cure. Participants must be in relatively good physical condition (ECOG PS 0-1), have measurable disease, proper organ function, and provide consent. Excluded are those with a second active cancer (except certain skin/cervical cancers), severe lung conditions, active hepatitis B/C, prior severe immunotherapy side effects, or recent serious respiratory issues.

Inclusion Criteria

I can care for myself and have been stable for two weeks.

Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

My organs are functioning well.

Exclusion Criteria

I have or had lung disease that needed steroids, or might have it based on recent scans.

I have needed extra oxygen or had serious lung problems in the last 6 months.

I have another cancer besides my current one, but it's been under control for less than 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of DS-1055a to determine the maximum tolerated dose

21 days per cycle

Multiple visits for dose escalation and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• DS-1055a

Trial Overview The trial is testing DS-1055a's safety and tolerability on participants with various types of advanced solid tumors like head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer or melanoma. It aims to find out how well patients can handle the drug when other treatments haven't worked.

How Is the Trial Designed?

Group I: Dose Escalation (DS-1055a) Experimental Treatment 1 Intervention

Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.

Who Is Running the Clinical Trial?

Daiichi Sankyo Co., Ltd.

Lead Sponsor

Trials

116

Recruited

49,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34235533/

Novel anti-GARP antibody DS-1055a augments anti-tumor ... We propose that DS-1055a is a new Treg-cell-targeted cancer immunotherapy agent with augmentation of anti-tumor immunity.

2. aacrjournals.org aacrjournals.org/cancerres/article/81/13_Supplement/1847/667728/Abstract-1847-Anti-GARP-antibody-DS-1055a-augments

Abstract 1847: Anti-GARP antibody DS-1055a augments ... Moreover, DS-1055a decreased FOXP3+CD4+ T cell counts in the TME and exhibited remarkable antitumor activity in a human peripheral blood ...

3. daiichisankyo.com daiichisankyo.com/media/press_release/detail/index_4081.html

First-in-human phase 1 study to evaluate DS-1055 ... First-in-human phase 1 study to evaluate DS-1055 as a new type of immune intervention for patients with relapsed/refractory advanced or metastatic solid tumors.

4. trial.medpath.com trial.medpath.com/drug/report/70773e005930dc54

DS-1055 | Advanced Drug Monograph - MedPath The antineoplastic effect is the anticipated outcome of this immune modulation, leading to an enhanced immune attack against tumor cells. 2.2.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04419532/a-study-evaluating-ds-1055a-in-participants-with-relapsed-or-refractory-locally-advanced-or-metastatic-solid-tumors

A Study Evaluating DS-1055a in Participants With ... The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced ...

6. daiichisankyo.us daiichisankyo.us/press-releases/-/article/daiichi-sankyo-initiates-phase-1-trial-with-immuno-oncology-therapy-ds-1055-targeting-garp-on-activated-regulatory-t-cells-

Press Releases “Evidence suggests that DS-1055 could serve as a new type of immune-based therapy for patients with various cancers, including those resistant ...

7. withpower.com withpower.com/trial/phase-1-neoplasms-9-2020-8f41c

DS-1055a for Cancer · Info for Participants This trial is testing a new drug called DS-1055a to see if it is safe and well-tolerated in patients with advanced solid tumors that haven't responded to ...

8. trial.medpath.com trial.medpath.com/clinical-trial/65c158f02719b7df/jprn-jrct2080225196-phase-1-study-ds-1055a-solid-tumors

A Phase 1, first in human study of DS-1055a in subjects with ... 1. Has a histopathologically documented locally advanced or metastatic head and neck, gastric, or esophageal cancer, non-small cell lung cancer, or melanoma.