Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
NCT ID: NCT06795412
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2025-04-15
2027-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.
PYX-201
Intravenous (IV) infusion.
pembrolizumab
IV infusion.
Part 2: Dose Expansion
Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.
PYX-201
Intravenous (IV) infusion.
pembrolizumab
IV infusion.
Interventions
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PYX-201
Intravenous (IV) infusion.
pembrolizumab
IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.
5. Life expectancy of \>3 months, in the opinion of the Investigator.
6. Adequate hematologic function.
7. Adequate hepatic function.
8. Adequate renal function.
9. Adequate coagulation profile.
10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.
Exclusion Criteria
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 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.
7. Participants with active neuropathy of any grade per CTCAE v5.0 at Screening.
8. History of uncontrolled diabetes mellitus.
9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
10. Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
11. Prior solid organ or bone marrow progenitor cell transplantation.
12. Prior high-dose chemotherapy requiring stem cell rescue.
13. 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.
14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Pyxis Oncology, Inc
INDUSTRY
Responsible Party
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Locations
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University of California San Diego
San Diego, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology Houston
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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KEYNOTE-G17
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-G17
Identifier Type: OTHER
Identifier Source: secondary_id
PYX-201-102
Identifier Type: -
Identifier Source: org_study_id
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