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

ConditionsSolid TumorSmall Cell Lung Cancer (SCLC)High Grade Neuroendocrine CancerSmall Cell Carcinomas of Non-lung OriginNon-small Cell Lung Cancer (NSCLC)Prostate CancerOvarian CancerRenal Carcinoma (Clear and Non-clear Cell)Head and Neck Squamous Cell Carcinoma (HNSCC)Hepatic CancerGastric CancerTriple-negative Breast Cancer (TNBC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

SCLC

High grade neuroendocrine or small cell carcinomas of non-lung origin

Non-small cell lung cancer [NSCLC]

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EXS74539

    Drug

    Oral administration

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: EXS74539Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Up to 3 years
2

Number of Participants with Dose-limiting Toxicity (DLT)

Time frame
Up to 28 days
3

Number of Participants with Dose Interruptions and Dose Modifications

Time frame
Up to 3 years

Secondary outcomes

1

Maximum Concentration (Cmax) of EXS74539

Time frame
Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)
2

Time to Cmax (tmax) of EXS74539

Time frame
Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)
3

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)
4

Objective Response Rate (ORR)

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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