What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly novel therapeutic agents like CX-904, include fatigue, nausea, diarrhea, skin rashes, and liver toxicity. More severe but less common side effects may include immune-related adverse events such as colitis, pneumonitis, and endocrinopathies. Targeted therapies can also cause hypertension and cardiac issues.

What prior FDA approvals exist?

Several novel therapeutic agents have received FDA approval for the treatment of solid tumors, focusing on inhibiting tumor growth or progression. For instance, Cabozantinib (XL184) is an oral tyrosine kinase inhibitor approved for medullary thyroid cancer, which targets multiple pathways involved in tumor growth. Immune checkpoint inhibitors like Pembrolizumab and Nivolumab have been approved for various solid tumors, including non-small cell lung cancer and melanoma, by targeting PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer. These treatments share a similar approach to CX-904, aiming to disrupt specific mechanisms that tumors use to grow and spread.

What other types of research exist?

Promising novel alternatives to CX-904 for solid tumor patients in 2024 include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in non-small cell lung cancer (NSCLC) and other solid tumors. 2) Atezolizumab (Tecentriq) combined with bevacizumab, particularly for renal cell carcinoma and other cancers. 3) Cabozantinib (Cabometyx), a tyrosine kinase inhibitor, effective in medullary thyroid cancer and other solid tumors. 4) Nivolumab (Opdivo) plus ipilimumab (Yervoy), an immunotherapy combination used in various cancers including renal cell carcinoma and mesothelioma. These therapies have demonstrated significant clinical benefits and are likely to be relevant options for solid tumor patients in 2024.

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CX-904 for Advanced Solid Cancers

Phase 1

Recruiting

Research Sponsored by CytomX Therapeutics

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CX-904, a new medicine that helps the immune system fight advanced cancers that can't be removed by surgery. It works by connecting immune cells to cancer cells, making it easier for the body to attack the cancer.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be surgically removed and have spread. They should have tried standard treatments already, not have serious heart issues or autoimmune diseases, and agree to use effective birth control. Those with small, symptom-free brain metastases may join after special consideration.

What is being tested?

The study tests CX-904's safety and effectiveness in treating advanced solid tumors. It will assess how the body processes the drug (PK), its impact on the tumor (PD), tolerability at different doses, and any potential benefits in shrinking or controlling tumor growth.

What are the potential side effects?

Since this is a first-in-human study for CX-904, specific side effects are unknown but could include typical reactions seen with cancer drugs such as nausea, fatigue, allergic reactions, blood count changes, organ inflammation or other unexpected symptoms.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

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My cancer is advanced, cannot be surgically removed, and I've had standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patients Experiencing Dose-limiting Toxicity

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

Investigator-assessed Progression-Free Survival (PFS)

+2 more

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: CX-904Experimental Treatment1 Intervention

0 / 2Eligibility 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 works by killing 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, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Novel agents like CX-904, which are being studied for their ability to inhibit tumor growth or progression, represent a promising approach by potentially offering more precise and effective treatment options with fewer side effects. These mechanisms are crucial for solid tumor patients as they aim to improve survival rates and quality of life by effectively controlling tumor growth while minimizing adverse effects.