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

Sponsor

Exscientia AI Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05920408

Collaborator

Biotrial (Industry)

110

Enrollment

Locations

Arm

34.7

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumours	Drug: EXS21546	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: EXS21546

EXS21546 Granule in Capsule for oral administration

Drug: EXS21546

EXS21546 Granule in Capsule

Outcome Measures

Primary Outcome Measures

Safety of EXS21546 in combination with nivolumab. [Through study completion, an average of 6 months]
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.
Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab. [Through dose escalation completion, an average of 6 months]
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.
Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab. [Through study completion, an average of 6 months]
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Treatment adherence of EXS21546 in combination with nivolumab. [Through study completion, an average of 6 months]
Number of doses recorded in the treatment diary.
Tolerability of EXS21546 in combination with nivolumab. [Through study completion, an average of 6 months]
Frequency of dose interruptions, dose reductions and dose intensity achieved.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institute Jules Bordet	Brussels	Belgium
2	CHU Mont-Godinne	Namur	Belgium
3	Institut Bergonie	Bordeaux	France
4	Centre GF Leclerc	Dijon	France	21000
5	Centre Eugene Marquis	Rennes	France

Sponsors and Collaborators

Exscientia AI Limited
Biotrial

Investigators

Principal Investigator: Antoine Italiano, MD, Institut Bergonie, Bordeaux, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Exscientia AI Limited

ClinicalTrials.gov Identifier:

NCT05920408

Other Study ID Numbers:

EXS21546-002

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jun 27, 2023