What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, radiation therapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lowered blood cell counts. Radiation therapy may lead to skin irritation, fatigue, and localized side effects depending on the treatment area, such as difficulty swallowing or breathing issues. Targeted therapies, which aim at specific cancer cell mechanisms, can cause side effects like diarrhea, liver problems, skin rashes, and high blood pressure. Patients should discuss potential side effects with their healthcare provider to manage and mitigate these symptoms effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for solid tumors, including traditional chemotherapies like cisplatin and paclitaxel, targeted therapies such as erlotinib and bevacizumab, and immunotherapies like pembrolizumab and nivolumab. These treatments work through different mechanisms, such as directly killing cancer cells, inhibiting specific molecular pathways, or enhancing the immune system's ability to fight cancer. The ongoing research in clinical trials often builds on these established therapies, exploring new combinations and novel agents to improve outcomes for patients with solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: <ol> <li>Pembrolizumab plus chemotherapy, as demonstrated in the KEYNOTE-189 trial for non-small cell lung cancer.</li> <li></li> </ol> Atezolizumab in combination with bevacizumab and chemotherapy, as shown in the IMpower150 trial for non-small cell lung cancer. 3. Cabozantinib, a tyrosine kinase inhibitor, which has shown activity in medullary thyroid cancer. 4. Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer. 5. Pembrolizumab as a single agent for metastatic sarcomatoid renal cell carcinoma, based on the KEYNOTE-427 trial.

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SPYK04 for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

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

Must have

Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable

ECOG performance status of 0 or 1

Must not have

Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)

Patients with a history or complication of interstitial lung disease (ILD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate the safety and initial effectiveness of a new treatment. Specific details about the intervention, patient group, and how the treatment works are not provided.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors where standard treatments failed or aren't suitable. They must be relatively healthy, meaning they can do daily activities without much help (ECOG status of 0 or 1). People with serious lung disease, recent heart problems, uncontrolled illnesses like heart disease or infections, or brain cancer/tumors needing treatment can't join.

What is being tested?

The study tests different doses of a new drug called SPYK04 on patients to see how much they can take and what effects it has. It's an early-phase trial (Phase I), which means it's one of the first times this drug is being given to people. The study is open-label and multi-center, so everyone knows what treatment they're getting and it's happening in several hospitals.

What are the potential side effects?

Since SPYK04 is new and this is a dose-escalation study to find out the best dose, specific side effects are not yet fully known. Generally, such trials look out for any signs of organ damage, allergic reactions, fatigue, nausea among others as potential side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread, and standard treatments haven't worked or can't be used.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have any severe, uncontrolled illnesses like heart, lung, or kidney diseases.

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I have a history of lung scarring or ILD.

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I have a brain tumor or cancer spread to my brain that needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pharmacokinetics of SPYK04 [Dose escalation]

Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]

Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]

+1 more

Secondary study objectives

Pharmacodynamics of SPYK04 [Cohort expansion]

Pharmacokinetics of SPYK04 [Cohort expansion]

Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion part in NSCLC, ovarian cancer and other solid tumorsExperimental Treatment1 Intervention

Patients will receive SPYK04 at the recommended dose.

Group II: Dose escalation cohort of SPYK04Experimental Treatment1 Intervention

Patients will receive SPYK04 at escalated dose.

0 / 6Eligibility 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

The most common treatments for solid tumors include chemotherapy, immunotherapy, targeted therapy, and radiation therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy boosts the body's immune system to recognize and attack cancer cells more effectively. Targeted therapy involves drugs designed to target specific molecules involved in cancer cell growth and survival, minimizing damage to normal cells. Radiation therapy uses high-energy particles or waves to destroy or damage cancer cells. Understanding these mechanisms is crucial for patients as it helps them comprehend how treatments work, potential side effects, and the rationale behind choosing a specific therapy, ultimately aiding in informed decision-making with their healthcare providers.

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