What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause neuropathy, fatigue, nausea, vomiting, diarrhea, and hematologic toxicities like neutropenia and anemia. Immunotherapy, such as checkpoint inhibitors, may lead to immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies can result in side effects like hypertension, hand-foot syndrome, and skin rashes. Each treatment's side effect profile varies, and patients should discuss these with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors focus on targeting tumor growth or inducing cancer cell death. For instance, pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors, including non-small cell lung cancer and melanoma. Similarly, nivolumab, another checkpoint inhibitor, is approved for renal cell carcinoma and melanoma. Additionally, bevacizumab, an angiogenesis inhibitor, is used in combination with chemotherapy for metastatic colorectal cancer and other solid tumors. These treatments work by either enhancing the immune system's ability to fight cancer or by directly inhibiting pathways critical for tumor growth and survival.

What other types of research exist?

Promising alternatives to DS-1055a for solid tumors include: 1) RO4987655 (CH4987655), an oral MEK inhibitor showing activity in various cancers with RAS-RAF mutations; 2) VS-6766, either alone or in combination with defactinib, for KRAS-mutant non-small-cell lung cancer; 3) Regorafenib, a multitargeted kinase inhibitor, for progressive or metastatic osteosarcoma; 4) Niraparib, a PARP inhibitor, for metastatic castration-resistant prostate cancer with HRR gene abnormalities.

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Monoclonal Antibodies

DS-1055a for Cancer

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 18 years of age or older.

Has a relapsed or refractory disease that is not amenable to curative standard therapy.

Must not have

Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.

Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2 immune-related adverse event.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for DS-1055a aren't listed here, common ones for similar drugs include immune system reactions leading to inflammation in different body parts; infusion-related symptoms; fatigue; nausea; changes in blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My condition cannot be cured with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I had severe side effects from previous immunotherapy.

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I have an active hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events

Number of participants with dose-limiting toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most appropriate treatment based on the tumor's specific characteristics and the patient's overall health.