PYX-201 for Solid Tumors

Recruiting at 23 trial locations

Overseen By Pyxis Oncology Clinical Trials Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pyxis Oncology, Inc

Disqualifiers: Brain metastases, Cardiovascular disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of PYX-201, an experimental treatment, and evaluate its effectiveness for individuals with certain solid tumors that have returned or resisted treatment. The study examines various cancers, including specific types of breast cancer, head and neck cancer, and other advanced tumors. Participants will receive the treatment through an IV to assess its safety and effectiveness. This trial may suit those with a confirmed solid tumor who have tried other treatments without success, particularly if the illness affects daily life. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have received systemic anticancer therapy within 28 days or within 5 half-lives before starting the study drug.

Is there any evidence suggesting that PYX-201 is likely to be safe for humans?

Research has shown that PYX-201, a new treatment being tested for solid tumors, holds promise. In earlier studies, patients with advanced solid tumors, including those in the head and neck, responded to this treatment. However, as PYX-201 is a new drug, researchers continue to monitor its safety closely.

The current study is in an early phase, focusing on determining the right dose and understanding any side effects. This phase typically assesses how well participants tolerate the drug. Although detailed safety information is not yet available, the FDA's fast track designation for PYX-201 in certain cancers suggests optimism about its potential benefits and manageable risks.

Participants in earlier studies reported varying results, but detailed side effect information has not been fully released. While PYX-201 might be effective, potential risks remain not fully understood. Consulting a healthcare provider is crucial when considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PYX-201 because it offers a novel approach to treating various solid tumors, including challenging cases like head and neck squamous cell carcinoma and triple-negative breast cancer. Unlike standard chemotherapies that broadly attack cancer cells, PYX-201 is designed to specifically target tumor cells, potentially reducing damage to healthy cells. Its administration as an intravenous infusion allows for precise dosing and direct delivery into the bloodstream, which can enhance its effectiveness. This targeted strategy could lead to better outcomes with fewer side effects, making it a promising option for patients who have limited responses to existing therapies.

What evidence suggests that this trial's treatment, PYX-201, could be effective for solid tumors?

Research has shown that PYX-201, an antibody-drug conjugate, holds promise for treating advanced solid tumors. In earlier studies, patients who had tried other treatments for their tumors responded well to PYX-201. This trial will explore PYX-201 in various treatment arms, including dose escalation and specific cohorts for different cancer types. Participants with difficult-to-treat cancers, such as head and neck cancer, triple-negative breast cancer, and other solid tumors, will receive PYX-201. The FDA has recognized its potential by granting fast-track status for head and neck cancers, highlighting its significance in this area. While more research is needed, early results are promising for those with these challenging conditions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have at least one tumor that can be measured or I have breast cancer that has spread to bones only.

I am fully active or can carry out light work.

Life expectancy of >3 months

Exclusion Criteria

I do not have an active infection needing treatment as I start PYX-201.

I had cancer before, but it's either completely treated or in remission for over 2 years.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of PYX-201 as an IV infusion to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity

3 weeks

Multiple visits (in-person)

Cohort Treatment

Participants in various cohorts receive PYX-201 as an IV infusion at the recommended dose

Up to approximately 2 years

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PYX-201

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2: Cohort D Experimental Treatment 1 Intervention

Participants with various advanced solid tumor types, including non-small cell lung cancer (NSCLC), sarcomas, rare solid tumor head and neck (H\&N) cancers, ovarian cancer (OVCA), cervical cancer, and endometrial cancer, will receive PYX-201 as an IV infusion at the recommended dose for Part 2.

Group II: Part 2: Cohort C Experimental Treatment 1 Intervention

Participants with hormone receptor (HR)-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry \[IHC\] 0, IHC 1+, or IHC 2+/in situ hybridization \[ISH\]-negative) breast cancer who had progressed on cyclin-dependent kinase 4/6 (CDK-4/6) inhibitors plus endocrine therapy and one line of chemotherapy, and had received no more than three prior lines of systemic therapy, will receive PYX-201 as an IV infusion at the recommended dose for Part 2.

Group III: Part 2: Cohort B Experimental Treatment 1 Intervention

Participants with triple-negative breast cancer (TNBC) who have been treated with at least one but no more than two lines of prior systemic therapy will receive PYX-201 as an IV infusion at the recommended dose for Part 2.

Group IV: Part 2: Cohort A Experimental Treatment 1 Intervention

Participants with recurrent, persistent, and/or metastatic head and neck squamous cell carcinoma (HNSCC) who have received at least one but no more than two lines of prior systemic therapy, including platinum-based therapy and a programmed cell death protein 1 (PD-1) inhibitor, and participants who have received up to two lines of prior therapy that must include one prior PD-1 inhibitor and one prior epidermal growth factor receptor (EGFR)-directed treatment, will receive PYX-201 as an IV infusion at the recommended dose for Part 2.

Group V: Part 1: PYX-201 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating doses of PYX-201 as an intravenous (IV) infusion 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.

Who Is Running the Clinical Trial?

Pyxis Oncology, Inc

Lead Sponsor

Trials

4

Recruited

400+

Published Research Related to This Trial

Patients with non-small-cell lung cancer (NSCLC) who have EGFR activating mutations experience significantly longer progression-free survival (PFS) when treated with EGFR tyrosine-kinase inhibitors (TKIs) like erlotinib (12.4 months) and gefitinib (9.4 months) compared to chemotherapy (5.6 months).

The analysis included data from 27 studies on erlotinib (731 patients) and 54 studies on gefitinib (1802 patients), demonstrating a clear advantage of TKIs over chemotherapy in extending PFS for EGFR mutation-positive NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of clinical outcome for EGFR TKI-treated patients with EGFR mutation-positive NSCLC. Paz-Ares, L., Soulières, D., Moecks, J., et al.[2021]

The I-SPY2 platform-based phase II studies have shown that combining durvalumab and olaparib with standard neoadjuvant chemotherapy significantly improves the pathological complete response rate in patients with HER2-negative breast cancer.

This treatment approach is effective regardless of the hormone receptor status, suggesting a broad applicability for these therapies in this specific breast cancer population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I-SPY2 platform: New lessons from the olaparib and durvalumab combination in breast cancer treatment. Perez-Garcia, J., Gion, M., Cortes, J.[2021]

A 37-year-old woman with HER2-positive advanced breast cancer showed a significant clinical response after treatment with a combination of pyrotinib, trastuzumab, paclitaxel, and cisplatin, achieving a clinical partial response after 4 cycles.

The patient underwent surgery and achieved a pathologic complete response, indicating that the combination therapy with pyrotinib can dramatically improve outcomes in patients with aggressive HER2-positive breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological Complete Response from Pyrotinib Combined with Trastuzumab, Paclitaxel and Cisplatin in a Postpartum Woman with HER2-Positive Locally Advanced Breast Cancer: A Case Report. He, L., Zhang, F., Ma, Y., et al.[2022]

In a study of 212 patients with metastatic breast cancer, the addition of bevacizumab to chemotherapy significantly prolonged progression-free survival (PFS) to 9.3 months compared to 7.6 months for chemotherapy alone, and overall survival (OS) to 28.9 months compared to 22.6 months.

Patients who developed hypertension during treatment with bevacizumab had a notably better outcome, with a PFS of 13.7 months and a 2-year OS rate of 78%, suggesting that hypertension may be a marker for treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension as a predictive marker for bevacizumab in metastatic breast cancer: results from a retrospective matched-pair analysis. Gampenrieder, SP., Romeder, F., Muß, C., et al.[2022]

In a phase II trial involving 20 female patients with HER2-positive operable and locally advanced breast cancer, the combination of pyrotinib with chemotherapy showed a total pathological complete response (tpCR) rate of 73.7%, indicating high efficacy in this treatment setting.

The treatment was generally safe, with the most common side effects being diarrhea and leukopenia in 90% of patients, but no severe (grade 5) adverse events were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. Xuhong, J., Qi, X., Tang, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05720117

NCT05720117 | Study of PYX-201 in Solid Tumors The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors, ...

2. onclive.com onclive.com/view/pyx-201-generates-responses-in-pretreated-advanced-hnscc-and-other-solid-tumors

PYX-201 Generates Responses in Pretreated Advanced ... Treatment with the novel antibody-drug conjugate PYX-201 led to responses in patients with previously treated advanced solid tumors, including head and neck ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06795412

NCT06795412 | Study of PYX-201 in Combination With ... The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with ...

4. ir.pyxisoncology.com ir.pyxisoncology.com/news-releases/news-release-details/pyxis-oncology-initiates-new-pyx-201-combination-trial-and

Pyxis Oncology Initiates New PYX-201 Combination Trial ... The Phase 1/2 combination study, PYX-201-102, is now actively recruiting and is on track to initiate dosing patients in Q1 2025 as planned.

5. targetedonc.com targetedonc.com/view/fda-grants-pyx-201-fast-track-status-in-hnscc

FDA Grants PYX-201 Fast Track Status in HNSCC PYX-201 has gained FDA fast track designation in recurrent or metastatic head and neck squamous cell carcinoma.

6. dana-farber.org dana-farber.org/clinical-trials/25-075

A Phase 1/2, Open-label, Global, Multicenter, Dose- ... The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with ...