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Study of PYX-106 in Solid Tumors

Status
Active
Cancer Type
Uterine Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05718557
Protocol IDs
PYX-106-101 (primary)
NCI-2023-03477
2022-002306-24
2023-509686-21-00
Study Sponsor
Pyxis Oncology, Inc

Summary

The primary objective of this study is to determine the recommended dose(s) of PYX-106 in
participants with relapsed/refractory solid tumors.

Eligibility

  1. Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
  2. 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.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  5. 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.
  6. Life expectancy of >3 months, in the opinion of the Investigator.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.