Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Official title

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

Overview

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Interventions

• Drug GTAEXS617
  Administered as specified in the treatment arm.
• Drug SoC
  Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Primary outcome measures

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 2 years]
• Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) [Time frame: Up to 28 days]
• Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [Time frame: Up to 2 years]

Secondary outcome measures (7)

• Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [Time frame: Up to 2 years]
• Maximum Plasma Concentration (Cmax) of GTAEXS617 [Time frame: Predose up to 24 hours postdose]
• Time Maximum Plasma Concentration (Tmax) of GTAEXS617 [Time frame: Predose up to 24 hours postdose]
• Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617 [Time frame: Predose up to 24 hours postdose]
• Duration of Response (DOR) [Time frame: Up to 2 years]
• Progression-Free Survival (PFS) [Time frame: Up to 2 years]
• Disease Control Rate (DCR) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy > 3 months.
• One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).
• Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.
• Adequate hematological, liver, and renal function.
• Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Exclusion criteria

• Active and clinically significant (CS) infection.
• Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.
• Symptomatic central nervous system (CNS) malignancy or metastases.
• Concurrent active or previous malignancy.
• Prior organ or allogeneic stem-cell transplantation.
• Moderate or severe cardiovascular disease.
• Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
• Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.
• Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.
• Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.
• Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
• Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment.

Note: Other protocol Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 5 centers

• The Beatson West of Scotland Cancer Centre — Glasgow
• UCL Hospitals NHS Foundation Trust — London
• The Christie NHS Foundation Trust — Manchester
• Newcastle Upon Tyne NHS Foundation Trust — Newcastle upon Tyne
• Oxford University Hospitals NHS Foundation Trust — Oxford

United States · 4 centers

• USC Norris Comprehensive Cancer Center — Los Angeles
• START Midwest — Grand Rapids
• START San Antonio — San Antonio
• START Mountain Region — West Valley City

Belgium · 4 centers

• GZA Ziekenhuizen - Campus Sint-Augustinus — Antwerp
• Clinique Universitaires Saint-Luc — Brussels
• Institute Jules Bordet — Brussels
• CHU Sart Tilman — Liège

Identifiers

NCT: NCT05985655 · GTAEXS617-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗