Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors

Official title

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors

Overview

The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.

Interventions

• Drug EXS74539
  Oral administration

Primary outcome measures

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Up to 3 years]
• Number of Participants with Dose-limiting Toxicity (DLT) [Time frame: Up to 28 days]
• Number of Participants with Dose Interruptions and Dose Modifications [Time frame: Up to 3 years]

Secondary outcome measures (7)

• Maximum Concentration (Cmax) of EXS74539 [Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)]
• Time to Cmax (tmax) of EXS74539 [Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)]
• Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of EXS74539 [Time frame: Cycle 1 Day 1 through end of treatment (up to approximately 3 years)]
• Objective Response Rate (ORR) [Time frame: Up to 3 years]
• Duration of Response (DoR) [Time frame: Up to 3 years]
• Progression-free Survival (PFS) [Time frame: Up to 3 years]
• Overall Survival (OS) [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically confirmed diagnosis of the following solid tumors:

• SCLC
• High grade neuroendocrine or small cell carcinomas of non-lung origin
• Non-small cell lung cancer \[NSCLC\]
• Prostate cancer
• Ovarian cancer
• Renal carcinoma \[clear and non-clear cell\]
• Head and neck squamous cell carcinoma
• Hepatic cancer
• Gastric cancer
• Triple-negative breast cancer \[TNBC\]
• Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion criteria

• Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
• Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.
• Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy <7 days of the first scheduled dose of the study treatment.
• Significant cardiac abnormalities.
• Major surgery within 28 days prior to the start of study treatment.

Note: Other protocol-defined inclusion and 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

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Start Lacn — Los Angeles
• START Dallas — Fort Worth
• START Mountain Region — West Valley City

Identifiers

NCT: NCT07517198 · EXS74539-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗