DS-1055a for Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Daiichi Sankyo Co., Ltd.

Disqualifiers: Second malignancy, ILD, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 other treatments. The study will also look at how the drug moves through the body and if it causes any immune reactions.

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.

Research Team

Clinical Study Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

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.

I am 18 years old or older.

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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.

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Trial Timeline

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

Treatment Details

Interventions

DS-1055a (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Dose Escalation (DS-1055a)Experimental Treatment1 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.