Advanced Solid TumoursPhase 1/2NCT05920408
Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours
A Phase 1/2 study testing EXS21546 in people with Advanced Solid Tumours, run by Exscientia AI Limited at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- EXS21546
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 11 Apr 2023to 23 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France3 sites
Institut Bergonie
Bordeaux
Centre GF Leclerc
Dijon, 21000
Centre Eugene Marquis
Rennes
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumours
- Being tested
- EXS21546
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXS21546Drug
EXS21546 Granule in Capsule
| Study group | Role | What they receive |
|---|---|---|
| EXS21546 | Experimental | EXS21546 Granule in Capsule for oral administration Receives: Drug: EXS21546 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Treatment adherence of EXS21546 in combination with nivolumab.
Number of doses recorded in the treatment diary.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start11 Apr 2023
- Primary completion27 Sep 2023
- Study completion23 Oct 2023
Why it stopped: Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exscientia AI Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Responsible party
- Sponsor
- Investigators
- Antoine Italiano, MD, Principal investigator, Institut Bergonie, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920408
- Sponsor's protocol ID
- EXS21546-002
- Status last verified
- Nov 2023
- First submitted
- 18 May 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05920408
- Acronym / sponsor ID
- EXS21546-002
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Exscientia AI LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXS21546 | Experimental | Drug: EXS21546EXS21546 Granule in Capsule for oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXS21546EXS21546 Granule in Capsule | Drug | EXS21546 |
Primary outcome
Safety of EXS21546 in combination with nivolumab.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
Number of doses recorded in the treatment diary.
Tolerability of EXS21546 in combination with nivolumab.
Time frame: Through study completion, an average of 6 months
Frequency of dose interruptions, dose reductions and dose intensity achieved.
Results and safety
The study was stopped early (reason given: Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Italiano, MD principal investigator
Institut Bergonie, Bordeaux, France
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EXS21546 in people with Advanced Solid Tumours, run by Exscientia AI Limited at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of EXS21546 in combination with nivolumab. (time frame: Through study completion, an average of 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.