What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause hematologic toxicities such as neutropenia, anemia, and thrombocytopenia, as well as non-hematologic toxicities like fatigue, nausea, vomiting, and diarrhea. Immunotherapies, such as nivolumab and ipilimumab, can lead to immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Targeted therapies, like sunitinib and pazopanib, may result in hypertension, hand-foot syndrome, and gastrointestinal disturbances. These side effects vary in severity and frequency depending on the specific agent and patient characteristics.

What prior FDA approvals exist?

The FDA has approved several anti-cancer agents for the treatment of solid tumors. Notable examples include pembrolizumab, an immune checkpoint inhibitor used for various solid tumors such as melanoma and non-small cell lung cancer, and regorafenib, a multi-kinase inhibitor approved for metastatic colorectal cancer and gastrointestinal stromal tumors. Additionally, agents like atezolizumab, a PD-L1 inhibitor, have been approved for urothelial carcinoma and non-small cell lung cancer. These treatments, like PYX-201, aim to target and inhibit cancer cell growth in solid tumors.

What other types of research exist?

Promising alternatives to PYX-201 for solid tumors include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as seen in the KEYNOTE trials, 2) Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy, as demonstrated in the IMpower trials, 3) Nivolumab (Opdivo) combined with ipilimumab (Yervoy), particularly for tumors with high mutational burden, and 4) Avelumab (Bavencio) combined with axitinib (Inlyta) for renal cell carcinoma and other solid tumors. These therapies have shown significant efficacy and safety in recent clinical trials.

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PYX-201 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Pyxis Oncology, Inc

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial aims to find the best dose to treat cancer in people with tumors that haven't responded to treatment.

Who is the study for?

Adults over 18 with certain types of advanced solid tumors, like lung or breast cancer, who've seen their disease get worse after treatment can join. They should be fairly active (ECOG 0-1), have a life expectancy over 3 months, and provide tumor samples. People with brain metastases needing high-dose steroids or recent major surgery can't participate.Check my eligibility

What is being tested?

The trial is testing different doses of PYX-201 to find the safest and most effective amount for treating various advanced solid tumors in patients whose previous treatments didn't work.See study design

What are the potential side effects?

Specific side effects of PYX-201 aren't listed here, but common ones for cancer drugs include nausea, fatigue, risk of infection, allergic reactions, and organ inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who Experience a Dose-limiting Toxicity (DLT)

Number of Participants who Experience an Adverse Event (AE)

Secondary outcome measures

Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum

Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum

Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PYX-201 Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. Intra-participant dose escalation may be considered for participants who have adequately tolerated therapy.

Do I qualify?Apply below to find out

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, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways essential for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for solid tumor patients as they offer different strategies to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments.

The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.

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Who is running the clinical trial?

Pyxis Oncology, IncLead Sponsor

2 Previous Clinical Trials

77 Total Patients Enrolled

Media Library

PYX-201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05720117 — Phase 1

Solid Tumors Research Study Groups: PYX-201 Dose Escalation

Solid Tumors Clinical Trial 2023: PYX-201 Highlights & Side Effects. Trial Name: NCT05720117 — Phase 1

PYX-201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720117 — Phase 1

~21 spots leftby Jun 2025

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