Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours

A Phase 1B/2A Study to Assess the Safety, Tolerability, Pharmacokinetic and Anti-tumoral Activity of EXS21546 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumours
• Intervention / Treatment: Drug: EXS21546

Detailed Description

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor, nivolumab, in patients with advanced solid tumours, non small cell lung cancer and renal cell carcinoma.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Institute Jules Bordet
  • Namur, Belgium
    • CHU Mont-Godinne
• France
  • Bordeaux, France
    • Institut Bergonie
  • Dijon, France, 21000
    • Centre GF Leclerc
  • Rennes, France
    • Centre Eugene Marquis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥ 18 years at time of informed consent.
• Previous histologically confirmed diagnosis of RCC or NSCLC having received previously checkpoint inhibitors as part of a SoC regimen.
• Consent to mandatory paired tumour biopsies of at least one tumour site accessible for repeat biopsies. Planned sites for tumour biopsies must not have been previously irradiated and could be a target lesion of >2 cm diameter according to RECIST v1.1 and must be approved on a case-by-case basis by the Sponsor.
• Measurable disease as per RECIST v1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).

Exclusion Criteria:

• Any anti-tumour therapy, including investigational therapies, within 4 weeks prior to the first dose of EXS21546.
• Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per CTCAE v5.0.
• Concurrent other malignancy that could interfere with response evaluation.
• Symptomatic central nervous system (CNS) malignancy or metastases. Screening of symptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions 60 days prior to study enrolment.
• History of interstitial lung disease and/or prior immunotherapy-related pneumonitis.
• Patients who have had or are scheduled to have major surgery < 28 days prior to the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXS21546; EXS21546 Granule in Capsule for oral administration	Drug: EXS21546; EXS21546 Granule in Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EXS21546 in combination with nivolumab.	Incidence of treatment-emergent adverse events (TEAEs) and SAEs characterised by type, incidence, severity (graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0), seriousness, timing and relationship to EXS21546 dosing.	Through study completion, an average of 6 months
Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab.	Incidence of dose limiting toxicities (DLTs) during Cycle 1 (initial 28 days) of treatment with escalating doses of EXS21546 in combination with an approved dose of nivolumab.	Through dose escalation completion, an average of 6 months
Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab.	Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.	Through study completion, an average of 6 months
Treatment adherence of EXS21546 in combination with nivolumab.	Number of doses recorded in the treatment diary.	Through study completion, an average of 6 months
Tolerability of EXS21546 in combination with nivolumab.	Frequency of dose interruptions, dose reductions and dose intensity achieved.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Exscientia AI Limited
• Collaborators: Biotrial
• Investigators: Principal Investigator: Antoine Italiano, MD, Institut Bergonié, Bordeaux, France

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: EXS21546-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No