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Testing PYX-201 for advanced solid tumors

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

Phase 1 Interventional Pyxis Oncology, Inc · NCT05720117

This study is testing a new drug called PYX-201 to see if it can safely help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorPyxis Oncology, Inc Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations29 sites (Scottsdale, Arizona and 28 other locations)
Trial IDNCT05720117 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of PYX-201 in patients with relapsed or refractory solid tumors. The primary objectives include determining the recommended doses of PYX-201 and assessing the objective response rate in participants treated with this medication as a single agent. Eligible participants must have confirmed solid tumors and meet specific health criteria, including adequate organ function and performance status. The study will involve fresh tumor biopsies or archived tissue samples for analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific types of relapsed or refractory solid tumors.

Not a fit: Patients with other active malignancies or those who do not meet the health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in targeting advanced solid tumors with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion

1. Histologically or cytologically confirmed solid tumors including locally advanced/metastatic HR+ and HER2- breast cancer (post CDK4/6 inhibitor +/- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1/PD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Life expectancy of \>3 months, in the opinion of the Investigator.
6. Corrected QTcF \<470 msec.
7. Adequate hematologic function.
8. Adequate hepatic function.
9. Adequate renal function.
10. Adequate coagulation profile.
11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

Exclusion

1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.
2. Known symptomatic brain metastases.
3. Significant cardiovascular disease within 6 months prior to start of study drug.
4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
7. Participants with NCI-CTCAE v5.0 Grade \>1 neuropathy of any etiology.
8. Prior solid organ or bone marrow progenitor cell transplantation.
9. Prior high-dose chemotherapy requiring stem cell rescue.
10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
11. Palliative radiation therapy within 14 days prior to the start of study drug.
12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
13. History of uncontrolled diabetes mellitus.
14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
17. Participants with a history of (noninfectious) pneumonitis/ interstitial lung disease that required steroids, has current pneumonitis/ interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Where this trial is running

Scottsdale, Arizona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorAdvanced Solid TumorRecurrent/Metastatic Solid TumorPYX-201
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.