Solid TumorPhase 1NCT05720117
A Study of PYX-201 in Advanced Solid Tumors
A Phase 1 study testing PYX-201 in people with Solid Tumor and Advanced Solid Tumor, run by Pyxis Oncology, Inc at 29 sites in 4 countries.
Trial summary
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor
- What is being tested?
- PYX-201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 14 Mar 2023to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Life expectancy of >3 months, in the opinion of the Investigator.
- Corrected QTcF <470 msec.
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- Adequate hematologic function.
- Adequate hepatic function.
- Adequate renal function.
- Adequate coagulation profile.
- Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.
Who cannot join
- 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.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to start of study drug.
- Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
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- Participants with NCI-CTCAE v5.0 Grade >1 neuropathy of any etiology.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
- Palliative radiation therapy within 14 days prior to the start of study drug.
- Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
- History of uncontrolled diabetes mellitus.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
- Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
- 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.
Trial locations and contacts
29 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 4 countries
United States17 sites, 17 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30308
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
NEXT Dallas
Dallas, Texas, 75231
- Recruiting
SCRI - HealthOne Denver
Denver, Colorado, 80218
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19106
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
NEXT San Antonio
San Antonio, Texas, 78229
- Recruiting
SCRI - Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, 08035
- Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, Madrid, 28050
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, València, 46010
Belgium4 sites, 4 recruiting
- Recruiting
Institut Jules Bordet
Brussels, Brussels Capital, 1070
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Edegem, 2650
- Recruiting
Universitair Ziekenhuis Gent
Ghent, Gent, 9000
United Kingdom3 sites, 2 recruiting
- Recruiting
University College Hospital
London, England, NW1 2PG
- Recruiting
The Royal Marsden Hospital
London, England, SW3 6JJ
- Active, not recruiting
Sarah Cannon Research Institute London
London, England, W1G 6AD
About this study
Official title: 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
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
- Conditions
- Solid Tumor, Advanced Solid Tumor
- Being tested
- PYX-201
- Keywords
- Recurrent/Metastatic Solid Tumor, PYX-201
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYX-201Drug
Antibody-Drug Conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Not described Receives: Drug: PYX-201 |
| Dose Expansion Cohort A (HNSCC) | Experimental | Not described Receives: Drug: PYX-201 |
| Dose Expansion Cohort B (TNBC) | Experimental | Not described Receives: Drug: PYX-201 |
| Dose Expansion Cohort C (HR+ HER2- BC) | Experimental | Not described Receives: Drug: PYX-201 |
| Dose Expansion Cohort D (Other Solid Tumor Types) | Experimental | Not described Receives: Drug: PYX-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
Measured: Day 1 to Day 21
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Measured: Up to approximately 3 years
Objective Response Rate (ORR) observed in participants in Dose Expansion
Measured: Up to approximately 2 years
Secondary outcomes (21)
Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Clearance (CL) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Half-life (t½) of PYX-201 in Dose Escalation
Pharmacokinetic (PK) assessments for PYX-201
Measured: Day 1 up to approximately 2 years
Objective Response Rate (ORR) observed in participants in Dose Escalation
Measured: Up to approximately 3 years
Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion
Measured: Up to approximately 3 years
Progression-free Survival (PFS) observed in participants in Dose Escalation
Measured: Up to approximately 3 years
Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion
Measured: Up to approximately 3 years
Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion
Measured: Up to approximately 3 years
Overall Survival (OS) observed in participants in Dose Escalation
Measured: Up to approximately 3 years
Incidence of Anti-drug Antibodies (ADA) in participants treated with PYX-201 in Dose Escalation and Dose Expansion
Measured: Up to approximately 2 years
Clinical Benefit Rate (CBR) observed in participants in Dose Expansion
Measured: Up to approximately 2 years
Median Progression-free Survival (mPFS) observed in participants in Dose Expansion
Measured: Up to approximately 4 years
Median Overall Survival (mOS) observed in participants in Dose Expansion
Measured: Up to approximately 4 years
Cmax of PYX-201 in Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Measured: Up to approximately 2 years
Tmax of PYX-201 in Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Measured: Up to approximately 2 years
Trough Concentration of PYX-201 in Dose Expansion
Pharmacokinetic (PK) assessments for PYX-201
Measured: Up to approximately 2 years
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Expansion
Adverse Events characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and ECG parameters will be recorded as AEs.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start14 Mar 2023
- Primary completion25 Apr 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pyxis Oncology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720117
- Sponsor's protocol ID
- PYX-201-101
- Other IDs
- 2023-509687-14-00, 2022-002284-30, 2023
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05720117
- Acronym / sponsor ID
- PYX-201-101
- Conditions
- Solid Tumor, Advanced Solid Tumor
- Keywords
- Recurrent/Metastatic Solid Tumor, PYX-201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Pyxis Oncology, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: PYX-201 |
| Dose Expansion Cohort A (HNSCC) | Experimental | Drug: PYX-201 |
| Dose Expansion Cohort B (TNBC) | Experimental | Drug: PYX-201 |
| Dose Expansion Cohort C (HR+ HER2- BC) | Experimental | Drug: PYX-201 |
| Dose Expansion Cohort D (Other Solid Tumor Types) | Experimental | Drug: PYX-201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Life expectancy of >3 months, in the opinion of the Investigator.
Key exclusion criteria (17 listed)
- 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.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to start of study drug.
- Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PYX-201Antibody-Drug Conjugate | Drug | Dose Escalation, Dose Expansion Cohort A (HNSCC), Dose Expansion Cohort B (TNBC), Dose Expansion Cohort C (HR+ HER2- BC), Dose Expansion Cohort D (Other Solid Tumor Types) |
Primary outcome
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation
Time frame: Day 1 to Day 21
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation
Time frame: Up to approximately 3 years
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Objective Response Rate (ORR) observed in participants in Dose Expansion
Time frame: Up to approximately 2 years
21 secondary outcomes
Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion
Time frame: Day 1 up to approximately 2 years
Clearance (CL) of PYX-201 in Dose Escalation
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation
Time frame: Day 1 up to approximately 2 years
Half-life (t½) of PYX-201 in Dose Escalation
Time frame: Day 1 up to approximately 2 years
Objective Response Rate (ORR) observed in participants in Dose Escalation
Time frame: Up to approximately 3 years
Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) observed in participants in Dose Escalation
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion
Time frame: Up to approximately 3 years
Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion
Time frame: Up to approximately 3 years
Overall Survival (OS) observed in participants in Dose Escalation
Time frame: Up to approximately 3 years
Incidence of Anti-drug Antibodies (ADA) in participants treated with PYX-201 in Dose Escalation and Dose Expansion
Time frame: Up to approximately 2 years
Clinical Benefit Rate (CBR) observed in participants in Dose Expansion
Time frame: Up to approximately 2 years
Median Progression-free Survival (mPFS) observed in participants in Dose Expansion
Time frame: Up to approximately 4 years
Median Overall Survival (mOS) observed in participants in Dose Expansion
Time frame: Up to approximately 4 years
Cmax of PYX-201 in Dose Expansion
Time frame: Up to approximately 2 years
Tmax of PYX-201 in Dose Expansion
Time frame: Up to approximately 2 years
Trough Concentration of PYX-201 in Dose Expansion
Time frame: Up to approximately 2 years
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Expansion
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PYX-201 in people with Solid Tumor and Advanced Solid Tumor, run by Pyxis Oncology, Inc at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Spain, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pyxis Oncology Clinical Trials Team ((339) 545 8252, clinicaltrials@pyxisoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation (time frame: Day 1 to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.