Study of PYX-201 in Solid Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PYX-201 Dose Escalation Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. |
Drug: PYX-201
Intravenous (IV) infusion
|
Outcome Measures
Primary Outcome Measures
- Number of Participants who Experience a Dose-limiting Toxicity (DLT) [Day 1 to Day 21]
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
- Number of Participants who Experience an Adverse Event (AE) [Up to approximately 3 years]
Type, incidence, seriousness, relationship to study treatment and severity of AEs, including serious AEs and AEs at Grade 3 or above, 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 Observed Concentration (Cmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Time to Maximum Concentration (tmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Clearance (CL) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Half-life (t½) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [Day 1 up to approximately 2 years]
- Objective Response Rate (ORR) [Up to approximately 3 years]
- Duration of Response (DOR) [Up to approximately 3 years]
- Progression-free Survival (PFS) [Up to approximately 3 years]
- Disease Control Rate (DCR) [Up to approximately 3 years]
- Time to Response [Up to approximately 3 years]
- Overall Survival (OS) [Up to approximately 3 years]
- Number of Participants With Anti-drug Antibodies to PYX-201 [Up to approximately 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or non-pregnant, non-lactating female participants age ≥18 years.
-
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), hormone receptor positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS), hepatocellular carcinoma (HCC), and kidney cancer.
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Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
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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.
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Life expectancy of >3 months, in the opinion of the Investigator.
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Participants must provide archived or fresh tumor samples. Fresh biopsy pre-treatment is preferred, archival tissue is acceptable if fresh biopsy is not performed at Screening.
Exclusion Criteria:
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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.
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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.
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Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of PYX-201 treatment.
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Major surgery within 4 weeks prior to the start of PYX-201 treatment, as defined by the Investigator.
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Prior solid organ or bone marrow progenitor cell transplantation.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pyxis Oncology, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PYX-201-101
- 2022-002284-30