CLINICAL TRIAL / NCT05718557
Study of PYX-106 in Solid Tumors
- Interventional
- Recruiting
- NCT05718557
Contact Information
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
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
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.
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; 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.
- Solid Tumors