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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05920408
Recruitment Status : Terminated (Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.)
First Posted : June 27, 2023
Last Update Posted : November 8, 2023
Sponsor:
Collaborator:
Biotrial
Information provided by (Responsible Party):
Exscientia AI Limited

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 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 : April 11, 2023
Actual Primary Completion Date : September 27, 2023
Actual Study Completion Date : October 23, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: EXS21546
EXS21546 Granule in Capsule for oral administration
 Drug: EXS21546
EXS21546 Granule in Capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920408


Locations
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Belgium
Institute Jules Bordet
Brussels, Belgium
CHU Mont-Godinne
Namur, Belgium
France
Institut Bergonie
Bordeaux, France
Centre GF Leclerc
Dijon, France, 21000
Centre Eugene Marquis
Rennes, France
Sponsors and Collaborators
Exscientia AI Limited
Biotrial
Investigators
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Principal Investigator: Antoine Italiano, MD Institut Bergonie, Bordeaux, France
More Information
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Responsible Party: Exscientia AI Limited
ClinicalTrials.gov Identifier: NCT05920408    
Other Study ID Numbers: EXS21546-002
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms