Study of PYX-106 in Solid Tumors
Study Details
Study Description
Brief Summary
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PYX-106 Dose Escalation Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s). |
Drug: PYX-106
Intravenous (IV) infusion
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) [Day 1 to Day 28]
- Number of Participants Who Experience an Adverse Event (AE) [Day 1 up to approximately 2 years]
Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Secondary Outcome Measures
- Maximum Concentration (Cmax) of PYX-106 [Day 1 up to approximately 2 years]
- Time to Maximum Concentration (Tmax) of PYX-106 [Day 1 up to approximately 2 years]
- Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106 [Day 1 up to approximately 2 years]
- Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106 [Day 1 up to approximately 2 years]
- Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106 [Day 1 up to approximately 2 years]
- Half Life (t1/2) of PYX-106 [Day 1 up to approximately 2 years]
- Objective Response Rate (ORR) [Day 1 up to approximately 2 years]
- Duration of Response (DOR) [Day 1 up to approximately 2 years]
- Progression Free Survival (PFS) [Day 1 up to approximately 2 years]
- Disease Control Rate (DCR) [Day 1 up to approximately 2 years]
- Time to Response [Day 1 up to approximately 2 years]
- Overall Survival (OS) [Day 1 up to approximately 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
-
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.
-
Participants must provide archived tumor samples (formalin-fixed paraffin-embedded [FFPE]) or fresh samples.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
-
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.
-
Life expectancy of >3 months, in the opinion of the Investigator.
Exclusion Criteria:
-
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.
-
Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
-
Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia.
-
Presence of Grade ≥2 peripheral neuropathy.
-
Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
-
Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
-
Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SCRI - HealthOne Denver | Denver | Colorado | United States | 80218 |
| 2 | NEXT Virginia | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Pyxis Oncology, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PYX-106-101
- 2022-002306-24