CLINICAL TRIAL / NCT05720117
Study of PYX-201 in Solid Tumors
- Interventional
- Recruiting
- NCT05720117
Contact Information
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 objective of this study is to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Male or non-pregnant, non-lactating female participants age ≥18 years.
2. Histologically or cytologically confirmed solid tumors (see details below):
For the dose escalation, the following solid tumors are allowed in participants who
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), which include non-small cell lung cancer (NSCLC),
head and neck squamous cell carcinomas (HNSCC), locally advanced/metastatic breast
cancer including hormone receptor (HR) positive (HR+) and negative (HR-) breast
cancer, human epidermal growth factor receptor 2 (HER2) negative (HER2-) and positive
(HER2+) breast cancer, and triple negative breast cancer (TNBC), ovarian cancer,
thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS),
hepatocellular carcinoma (HCC), and kidney cancer.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Participant must have at least 1 measurable lesion Response Evaluation Criteria in
Solid Tumors (RECIST) Version 1.1 criteria (by local Investigator) except participants
with bone-only metastatic breast cancer (mBC) who can be enrolled without measurable
disease. Participant must have radiographic evidence of disease progression based on
RECIST criteria following the most recent line of treatment.
5. Life expectancy of >3 months, in the opinion of the Investigator.
6. Clinical sites must conduct fresh tumor biopsy (formalin-fixed, paraffin-embedded
[FFPE]) or provide participants' archived tissue; 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-201) 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.
Exclusion Criteria:
1. 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; other adequately treated Stage 1 or 2 cancers
currently in complete remission; or any other cancer that has been in complete
remission for >2 years or cancer of low risk of recurrence if agreed to by the medical
monitor, except any treated or monitored indolent cancer that is unlikely to cause
mortality in 5 years.
2. Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or its
equivalent) at the time of signing informed consent. Participants with previously
diagnosed brain metastases are eligible if they have completed their treatment, have
recovered from the acute effects of radiation therapy or surgery prior to the start of
PYX-201 treatment, fulfill the steroid requirement for these metastases, and are
neurologically stable based on central nervous system imaging ≥4 weeks after
treatment.
3. Evidence of an active systemic bacterial, fungal, or viral infection requiring
treatment at the start of PYX-201 treatment.
4. Major surgery within 4 weeks prior to the start of PYX-201 treatment, as defined by
the Investigator.
5. Prior solid organ or bone marrow progenitor cell transplantation.
- Solid Tumors