Actively Recruiting
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Led by Pyxis Oncology, Inc · Updated on 2026-05-04
220
Participants Needed
19
Research Sites
137 weeks
Total Duration
On this page
Sponsors
P
Pyxis Oncology, Inc
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced solid tumors, including first-line head and neck squamous cell carcinoma, advanced/metastatic triple negative breast cancer, hormone receptor positive and HER2-negative breast cancer, gastric cancer, cervical cancer, and second-line or higher head and neck squamous cell carcinoma
- Male or non-pregnant, non-lactating female participants aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status of 0 to 1
- At least one measurable lesion according to RECIST v1.1 criteria
- Life expectancy greater than 3 months as judged by the Investigator
- Adequate hematologic function
- Adequate hepatic function
- Adequate renal function
- Adequate coagulation profile
- Availability of fresh tumor biopsy or archived tumor tissue sample
You will not qualify if you...
- Known additional malignancy progressing or requiring active treatment within the past 2 years
- Active central nervous system metastases or carcinomatous meningitis
- Significant cardiovascular disease within 6 months before study drug start
- Active systemic bacterial, fungal, or viral infection requiring treatment at study drug start
- Known active hepatitis B, hepatitis C, HIV, or AIDS
- Failure to recover to baseline severity or CTCAE v5.0 Grade 1 or better from acute non-hematologic toxicity of prior therapy before screening
- Grade greater than 1 neuropathy or receiving treatment for neuropathy at screening
- History of uncontrolled diabetes mellitus
- Immunodeficiency or active autoimmune disease contraindicated for pembrolizumab
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/ILD
- Prior organ or bone marrow transplantation
- Prior high-dose chemotherapy requiring stem cell rescue
- Previous treatment with PD-1/L1 inhibitors or agents targeting T-cell receptors
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab, PYX-201, or their excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
NEXT Oncology Houston
Houston, Texas, United States, 77054
Actively Recruiting
11
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Hopital Saint - Andre - CHU de Bordeaux
Bordeaux, France, 33075
Actively Recruiting
13
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
14
Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
15
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
16
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
17
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
18
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
19
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
P
Pyxis Oncology Clinical Trial Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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