A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions

NCT05836623 | Active Not Recruiting Phase 1

• 2 other identifiers: CBT307-1-RL2021-006256-13
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.

Conditions

Advanced and/or Metastatic Solid Tumours

Keywords

Phase 1 Study; Solid Tumours; Castration-resistant prostate cancer (CRPC); Prostate Specific Membrane Antigen (PSMA); Crescendo Biologics; CD137; CB307; Humabody®; Radiolabelled CB307; 89-Zirconium; Biodistribution; HSA

Outcome Measures

Primary Outcomes (4)

• Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307.

  Incidence (frequency and severity) of adverse events following administration of 89Zr-CB307 assessed by CTCAE version 5.0

  Throughout study completion, up to 8 months from first patient recruited.

• Assessment of 89Zr-CB307 uptake by PET scan by measuring maximum standardized uptake value in the tumour lesions.

  SUVpeak - maximum standardized uptake value.

  Throughout study completion, up to 8 months from first patient recruited.

• Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions.

  SUVmean - mean standardized uptake value.

  Throughout study completion, up to 8 months from first patient recruited.

• Assessment of 89Zr-CB307 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the tumour lesions.

  %ID/g - percentage of injected dose per gram.

  Throughout study completion, up to 8 months from first patient recruited.

Study Arms (2)

Part A - Optimisation Phase

EXPERIMENTAL

Following administration of 89Zr-CB307, patients will undergo PET scans The timing of the scans and CB307 dose administration will be determined by the Optimisation Review Committee (ORC)

Drug: Radiolabelled CB307; Drug: CB307

Part B - Expansion phase

EXPERIMENTAL

89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC)

Drug: Radiolabelled CB307; Drug: CB307

Interventions

Radiolabelled CB307 DRUG

CB307 radiolabelled with 89-Zirconium (89Zr CB307): drug product is formulated at a concentration of 1 mg/mL (37 MBq)

Also known as: 89Zr-CB307

Part A - Optimisation Phase; Part B - Expansion phase

CB307 DRUG

Trispecific Humabody® targeting CD137, prostate specific membrane antigen and human serum albumin

Part A - Optimisation Phase; Part B - Expansion phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding the written informed consent.
• Aged at least 18 years.
• Not amenable to standard of care.
• ECOG PS of 0 or 1.
• Documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours.
• Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastases.
• Adequate organ function.
• Willing to have a biopsy sample taken immediately after the last PET scan before initiation of the main study.

You may not qualify if:

• Subjects with autoimmune disease or regular immunosuppressants.
• Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity.
• Has brain metastasis including leptomeningeal metastasis or primary brain tumour.
• Has current or history of CNS disease.
• Has known active infection.
• Biopsy cannot be safely obtained after the last PET scan, and not provided their consent.

Sponsors & Collaborators

• Crescendo Biologics Ltd.: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

University Medical Center Groningen,

Groningen, P.O. Box 30 001, Netherlands

Location

Study Officials

• Julia Tilson

  Crescendo Biologics Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label single center non-randomised study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following administration of 89Zr-CB307, enrolled patients will undergo a number of PET scans where uptake of the radiolabelled drug will be assessed

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 1, 2023
• Study Start: December 20, 2022
• Primary Completion: January 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)