120 Participants Needed

PYX-201 for Solid Tumors

Recruiting at 18 trial locations
LV
Overseen ByLoan Vuong
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pyxis Oncology, Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing PYX-201, a new drug, to find the best dose for patients whose solid tumors have returned or didn't respond to other treatments. The drug aims to either kill cancer cells or boost the immune system to fight the cancer.

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.

What data supports the effectiveness of the drug PYX-201 for solid tumors?

While there is no direct data on PYX-201, similar drugs like pyrotinib, which is also a tyrosine kinase inhibitor (a type of drug that blocks certain proteins involved in cancer cell growth), have shown effectiveness in treating HER2-positive breast cancer when combined with other treatments.12345

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
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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.
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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?
5Treatment groups
Experimental Treatment
Group I: Part 2: Cohort DExperimental Treatment1 Intervention
Group II: Part 2: Cohort CExperimental Treatment1 Intervention
Group III: Part 2: Cohort BExperimental Treatment1 Intervention
Group IV: Part 2: Cohort AExperimental Treatment1 Intervention
Group V: Part 1: PYX-201 Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pyxis Oncology, Inc

Lead Sponsor

Trials
4
Recruited
400+

Published Research Related to This Trial

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.
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 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.
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]
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.
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]

Citations

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. [2022]
Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. [2022]
Pooled analysis of clinical outcome for EGFR TKI-treated patients with EGFR mutation-positive NSCLC. [2021]
I-SPY2 platform: New lessons from the olaparib and durvalumab combination in breast cancer treatment. [2021]
Hypertension as a predictive marker for bevacizumab in metastatic breast cancer: results from a retrospective matched-pair analysis. [2022]
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