for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around



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

Official Title

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors


Solid Tumor, Solid Tumors, Advanced Solid Tumors, PYX-106, Relapsed Solid Tumors, Refractory Solid Tumors, Neoplasms


You can join if…

Open to people ages 18 years and up

  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 developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable, which include 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 (the most recent available) is acceptable if fresh biopsy is not performed 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 based on RECIST criteria following the most recent line of treatment.
  6. Life expectancy of >3 months, in the opinion of the Investigator.

You CAN'T join if...

  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; other adequately treated Stage 1 or 2 cancers currently in complete remission; any other cancer that has been in complete remission for >2 years or cancer of low risk of recurrence; or 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.
  3. Continuance of toxicities due to prior anti-cancer agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia or endocrine deficiencies treated with stable hormone replacement therapy.
  4. Presence of Grade ≥2 peripheral neuropathy.
  5. Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
  6. Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
  7. Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.


  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States


accepting new patients
Start Date
Completion Date
Pyxis Oncology, Inc
Phase 1 research study
Study Type
Expecting 45 study participants
Last Updated