Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2024-06-14

Brief Summary

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The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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89Zr-S095012 tracer with S095012

Group Type EXPERIMENTAL

89Zr-S095012 tracer and S095012 will be administered via an IV infusion

Intervention Type DRUG

Imaging period 1 (Part A and Part B): The tracer will be administered with S095012 at non-therapeutic mass dose. The optimal mass dose of S095012 will be investigated in part A, and used in part B.

Treatment period (Part A to C): S095012 will be administered with multiple 28 days- cycles in a Q2W schedule.

Imaging period 2 (Part C): A second tracer dose will be administered at 1st treatment dose of S095012 in part C.

Interventions

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89Zr-S095012 tracer and S095012 will be administered via an IV infusion

Imaging period 1 (Part A and Part B): The tracer will be administered with S095012 at non-therapeutic mass dose. The optimal mass dose of S095012 will be investigated in part A, and used in part B.

Treatment period (Part A to C): S095012 will be administered with multiple 28 days- cycles in a Q2W schedule.

Imaging period 2 (Part C): A second tracer dose will be administered at 1st treatment dose of S095012 in part C.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated
* At least one measurable target lesion as per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
* Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
* Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards.

Exclusion Criteria

* Participants with no available archived material and no tumour lesions amenable to biopsy
* Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
* Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
* Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
* Participants who received either systemic corticosteroids (\> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded.
* Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
* Participants with a history of progressive multifocal leukoencephalopathy
* Participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No