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

Advanced Solid Tumours Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05920408
• Other study ID #: EXS21546-002
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 11, 2023
• Est. completion date: October 23, 2023

Study information

• Verified date: November 2023
• Source: Exscientia AI Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 23, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumours
• Neoplasms

Intervention

Drug:
• EXS21546
EXS21546 Granule in Capsule

Locations

Country	Name	City	State
Belgium	Institute Jules Bordet	Brussels
Belgium	CHU Mont-Godinne	Namur
France	Institut Bergonie	Bordeaux
France	Centre GF Leclerc	Dijon
France	Centre Eugene Marquis	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Exscientia AI Limited	Biotrial

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Treatment adherence of EXS21546 in combination with nivolumab.	Number of doses recorded in the treatment diary.	Through study completion, an average of 6 months
Primary	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