Clinical trial NCT05920408: Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumours
Lead sponsor: Exscientia AI Limited
Sponsor class: INDUSTRY
Collaborators: name: Biotrial
First posted: 2023-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of EXS21546 in combination with nivolumab.
timeFrame: Through study completion, an average of 6 months
measure: Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab.
timeFrame: Through dose escalation completion, an average of 6 months
measure: Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab.
timeFrame: Through study completion, an average of 6 months
measure: Treatment adherence of EXS21546 in combination with nivolumab.
timeFrame: Through study completion, an average of 6 months
measure: Tolerability of EXS21546 in combination with nivolumab.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute Jules Bordet
city: Namur
country: Belgium
facility: CHU Mont-Godinne
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon
country: France
facility: Centre GF Leclerc
city: Rennes
country: France
facility: Centre Eugene Marquis
Study officials:
affiliation: Institut Bergonie, Bordeaux, France
name: Antoine Italiano, MD
role: PRINCIPAL_INVESTIGATOR
References: