Study of PYX-201 in Solid Tumors

Solid Tumor Clinical Trial

Official title:

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720117
• Other study ID #: PYX-201-101
• Secondary ID: 2022-002284-30
• Status: Recruiting
• Phase: Phase 1
• Start date: March 14, 2023
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Pyxis Oncology, Inc
• Contact: Loan Vuong
• Phone: (339) 545 8252
• Email: clinicaltrials[@]pyxisoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female participants age =18 years.

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 (according to the Investigator), which include non-small cell lung cancer (NSCLC), head and neck squamous cell carcinomas (HNSCC), locally advanced/metastatic breast cancer including hormone receptor (HR) positive (HR+) and negative (HR-) breast cancer, human epidermal growth factor receptor 2 (HER2) negative (HER2-) and positive (HER2+) breast cancer, and triple negative breast cancer (TNBC), ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS), hepatocellular carcinoma (HCC), and kidney cancer.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

4. 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.

5. Life expectancy of >3 months, in the opinion of the Investigator.

6. Clinical sites must conduct fresh tumor biopsy (formalin-fixed, paraffin-embedded [FFPE]) or provide participants' archived tissue; 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-201) 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.

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, 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.

2. 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.

3. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of PYX-201 treatment.

4. Major surgery within 4 weeks prior to the start of PYX-201 treatment, as defined by the Investigator.

5. Prior solid organ or bone marrow progenitor cell transplantation.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms
• Solid Tumor

Intervention

Drug:
• PYX-201
Intravenous (IV) infusion

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Spain	Hospital Universitari Vall d'Hebrón	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	START Madrid - Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico Universitario de Valencia	València
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago Medicine	Chicago	Illinois
United States	NEXT Dallas	Dallas	Texas
United States	SCRI - HealthOne Denver	Denver	Colorado
United States	NEXT Virginia	Fairfax	Virginia
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	NEXT San Antonio	San Antonio	Texas
United States	SCRI - Florida Cancer Specialists	Sarasota	Florida
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pyxis Oncology, Inc

Countries where clinical trial is conducted

United States,  Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience a Dose-limiting Toxicity (DLT)	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.	Day 1 to Day 21
Primary	Number of Participants who Experience an Adverse Event (AE)	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.	Up to approximately 3 years
Secondary	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
Secondary	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
Secondary	Clearance (CL) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum		Day 1 up to approximately 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Objective Response Rate (ORR)		Up to approximately 3 years
Secondary	Duration of Response (DOR)		Up to approximately 3 years
Secondary	Progression-free Survival (PFS)		Up to approximately 3 years
Secondary	Disease Control Rate (DCR)		Up to approximately 3 years
Secondary	Time to Response		Up to approximately 3 years
Secondary	Overall Survival (OS)		Up to approximately 3 years
Secondary	Number of Participants With Anti-drug Antibodies to PYX-201		Up to approximately 2 years