Advanced Solid TumorsPhase 1/2NCT06795412
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1/2 study testing PYX-201 and pembrolizumab in people with Advanced Solid Tumors, run by Pyxis Oncology, Inc at 22 sites in 3 countries.
Trial summary
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 pembrolizumab for participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PYX-201 and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 15 Apr 2025to 6 Dec 2027
- Phase
- Phase 1/2
- 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 advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Life expectancy of >3 months, in the opinion of the Investigator.
- Adequate hematologic function.
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- 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
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Have any active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.
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- Participants with Grade >1 neuropathy of any grade per CTCAE v5.0 and/or receiving treatment for neuropathy at Screening.
- History of uncontrolled diabetes mellitus.
- Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
- Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.
- Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
United States13 sites, 13 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
University of Texas - M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Oncology Houston
Houston, Texas, 77054
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Stephenson Cancer Center - University of Oklahoma
Oklahoma City, Oklahoma, 73104
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
University of California San Diego
San Diego, California, 92093
- Recruiting
Sarcoma Oncology Center
Santa Monica, California, 90403
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
France4 sites, 4 recruiting
- Recruiting
Hopital Saint - Andre - CHU de Bordeaux
Bordeaux, 33075
- Recruiting
Centre Léon Bérard
Lyon, 69373
- Recruiting
Hôpital de la Timone
Marseille, 13385
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: A Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
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 pembrolizumab for participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- PYX-201, pembrolizumab
- Keywords
- Advanced Solid Tumors, PYX-201, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYX-201Drug
Intravenous (IV) infusion.
pembrolizumabDrug
Also called KEYTRUDA®
IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab. Receives: Drug: PYX-201; Drug: pembrolizumab |
| Part 2: Dose Expansion | Experimental | Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined. Receives: Drug: PYX-201; Drug: pembrolizumab |
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 21
Number of Participants who Experience an Adverse Event (AE)
Measured: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters
Measured: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Measured: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters
Measured: Up to approximately 2 years
Secondary outcomes (15)
Objective Response Rate (ORR)
Measured: Day 1 up to approximately 2 years
Duration of Response (DOR)
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
Clinical Benefit Rate (CBR)
Measured: Day 1 up to approximately 2 years
Maximum Observed Concentration (Cmax) of PYX-201
Measured: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201
Measured: Day 1 up to approximately 2 years
Clearance (CL) of 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
Measured: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of 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
Measured: Day 1 up to approximately 2 years
Half-Life (t½) for Antibody-drug Conjugate (ADC)
Measured: Day 1 up to approximately 2 years
Half-Life (t½) for Total Antibody (tAb)
Measured: Day 1 up to approximately 2 years
Half-Life (t½) for Free Payload
Measured: Day 1 up to approximately 2 years
Incidence of Anti-PYX-201 Antibodies
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 posted28 Jan 2025
- Study start15 Apr 2025
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pyxis Oncology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795412
- Sponsor's protocol ID
- PYX-201-102
- Other IDs
- KEYNOTE-G17, MK-3475-G17, 2025-521828-30-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06795412
- Acronym / sponsor ID
- PYX-201-102
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, PYX-201, Pembrolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Pyxis Oncology, IncIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 6 Dec 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 28 Jan 2025 (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 Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: PYX-201, Drug: pembrolizumabParticipants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab. |
| Part 2: Dose Expansion | Experimental | Drug: PYX-201, Drug: pembrolizumabPart 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.
- Male or non-pregnant, non-lactating female participants age ≥18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
- Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Life expectancy of >3 months, in the opinion of the Investigator.
Key exclusion criteria (14 listed)
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Have any active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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-201Intravenous (IV) infusion. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| pembrolizumabAlso: KEYTRUDA®IV infusion. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters
Time frame: Up to approximately 2 years
15 secondary outcomes
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
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
Clinical Benefit Rate (CBR)
Time frame: Day 1 up to approximately 2 years
Maximum Observed Concentration (Cmax) of PYX-201
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201
Time frame: Day 1 up to approximately 2 years
Clearance (CL) of PYX-201
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
Time frame: Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201
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
Time frame: Day 1 up to approximately 2 years
Half-Life (t½) for Antibody-drug Conjugate (ADC)
Time frame: Day 1 up to approximately 2 years
Half-Life (t½) for Total Antibody (tAb)
Time frame: Day 1 up to approximately 2 years
Half-Life (t½) for Free Payload
Time frame: Day 1 up to approximately 2 years
Incidence of Anti-PYX-201 Antibodies
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 2 Sep 2026.
- 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.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PYX-201 and pembrolizumab in people with Advanced Solid Tumors, run by Pyxis Oncology, Inc at 22 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 10 inclusion and 14 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Trial Team (617-453-3596, 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) (time frame: Day 1 to Day 21). The study lists 5 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 2 Sep 2026.