Solid TumorPhase 1NCT05718557
Study of PYX-106 in Solid Tumors
A Phase 1 study testing PYX-106 in people with Solid Tumor, run by Pyxis Oncology, Inc at 20 sites in 3 countries.
Trial summary
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- PYX-106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 23 May 2023to May 2026
- 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
- Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
- Histologically or cytologically confirmed solid tumors (see details below):
- For the dose escalation, the following solid tumors are allowed in participants who have relapsed, been non-responsive, or have developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the Investigator and after informing the Medical Monitor): non small cell lung cancer (without driver mutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma.
- Clinical sites must provide archived tissue or conduct fresh tumor biopsy (formalin-fixed paraffin-embedded [FFPE]; enough to create a minimum of 14 slides). Fresh biopsy pre-treatment is preferred, archival tissue (preferably obtained within 1 year prior to the first infusion of PYX-106) is acceptable if fresh biopsy is not medically feasible, per Investigator, at Screening. Both fresh and archival tissue samples must be collected by core needle biopsy or surgical resection. Fine needle aspirates are not permitted.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 criteria (by local Investigator). Participant must have radiographic evidence of disease progression per Investigator following the most recent line of treatment.
- Life expectancy of >3 months, in the opinion of the Investigator.
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; other adequately treated Stage 1 or 2 cancers currently in complete remission; any other cancer that has been in complete remission for >2 years or cancer of low risk of recurrence; or any treated or monitored indolent cancer that is unlikely to cause mortality in 5 years.
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
- Continuance of toxicities due to prior anti-cancer agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia or endocrine deficiencies treated with stable hormone replacement therapy.
- Presence of Grade ≥2 peripheral neuropathy.
- Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
- Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
- Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States11 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Gabrail Cancer and Research Center
Canton, Ohio, 44718
University of Chicago Medicine
Chicago, Illinois, 60637
SCRI- HealthOne Denver
Denver, Colorado, 80218
NEXT Virginia
Fairfax, Virginia, 22031
NEXT Oncology
Irving, Texas, 75039
University of California San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Lifespan - Rhode Island Hospital
Providence, Rhode Island, 02906
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Spain5 sites
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
HM Centro Integral Oncológico Clara Campal
Madrid, Madrid, 28050
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Grand Hôpital de Charleroi - Notre Dame
Charleroi, Hainaut, 6000
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000
About this study
Official title: A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
- Conditions
- Solid Tumor
- Being tested
- PYX-106
- Keywords
- Solid Tumors, Advanced Solid Tumors, PYX-106, Relapsed Solid Tumors, Refractory Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYX-106Drug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| PYX-106 Dose Escalation | Experimental | Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s). Receives: Drug: PYX-106 |
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)
Measured: Day 1 to Day 28
Number of Participants Who Experience an Adverse Event (AE)
Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (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: Day 1 up to approximately 19 months
Secondary outcomes (12)
Maximum Concentration (Cmax) of PYX-106
Measured: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-106
Measured: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
Measured: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106
Measured: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106
Measured: Day 1 up to approximately 2 years
Half Life (t1/2) of PYX-106
Measured: Day 1 up to approximately 2 years
Objective Response Rate (ORR)
Measured: Day 1 up to approximately 2 years
Duration of Response (DOR)
Measured: Day 1 up to approximately 2 years
Progression Free Survival (PFS)
Measured: Day 1 up to approximately 2 years
Disease Control Rate (DCR)
Measured: Day 1 up to approximately 2 years
Time to Response
Measured: Day 1 up to approximately 2 years
Overall Survival (OS)
Measured: Day 1 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 posted8 Feb 2023
- Study start23 May 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pyxis Oncology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718557
- Sponsor's protocol ID
- PYX-106-101
- Other IDs
- 2022-002306-24, 2023-509686-21-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Aug 2025. 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, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05718557
- Acronym / sponsor ID
- PYX-106-101
- Conditions
- Solid Tumor
- Keywords
- Solid Tumors, Advanced Solid Tumors, PYX-106, Relapsed Solid Tumors, Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pyxis Oncology, IncIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 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 objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PYX-106 Dose Escalation | Experimental | Drug: PYX-106Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
- Histologically or cytologically confirmed solid tumors (see details below):
- For the dose escalation, the following solid tumors are allowed in participants who have relapsed, been non-responsive, or have developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the Investigator and after informing the Medical Monitor): non small cell lung cancer (without driver mutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma.
- Clinical sites must provide archived tissue or conduct fresh tumor biopsy (formalin-fixed paraffin-embedded [FFPE]; enough to create a minimum of 14 slides). Fresh biopsy pre-treatment is preferred, archival tissue (preferably obtained within 1 year prior to the first infusion of PYX-106) is acceptable if fresh biopsy is not medically feasible, per Investigator, at Screening. Both fresh and archival tissue samples must be collected by core needle biopsy or surgical resection. Fine needle aspirates are not permitted.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Key exclusion criteria (7 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; other adequately treated Stage 1 or 2 cancers currently in complete remission; any other cancer that has been in complete remission for >2 years or cancer of low risk of recurrence; or any treated or monitored indolent cancer that is unlikely to cause mortality in 5 years.
- Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
- Continuance of toxicities due to prior anti-cancer agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia or endocrine deficiencies treated with stable hormone replacement therapy.
- Presence of Grade ≥2 peripheral neuropathy.
- Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
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-106Intravenous (IV) infusion | Drug | PYX-106 Dose Escalation |
Primary outcome
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Day 1 to Day 28
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Day 1 up to approximately 19 months
Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
12 secondary outcomes
Maximum Concentration (Cmax) of PYX-106
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106
Time frame: Day 1 up to approximately 2 years
Half Life (t1/2) of PYX-106
Time frame: Day 1 up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Day 1 up to approximately 2 years
Duration of Response (DOR)
Time frame: Day 1 up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Day 1 up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Day 1 up to approximately 2 years
Time to Response
Time frame: Day 1 up to approximately 2 years
Overall Survival (OS)
Time frame: Day 1 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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PYX-106 in people with Solid Tumor, run by Pyxis Oncology, Inc at 20 sites in 3 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) (time frame: Day 1 to Day 28). The study lists 2 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 3 Aug 2025.