Description:
FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell
enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety
and torelability to determine MTD and RP2D.
Title
- Brief Title: Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
- Official Title: A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients With PSMA+ Advanced and/or Metastatic Solid Tumours
Clinical Trial IDs
- ORG STUDY ID:
CBT307-1
- SECONDARY ID:
2019-004584-46
- NCT ID:
NCT04839991
Conditions
- Advanced and/or Metastatic Solid Tumours
Interventions
| Drug | Synonyms | Arms |
|---|
| CB307 | | Multi center open label Dose Escalation followed by cohort expansion |
Purpose
FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell
enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety
and torelability to determine MTD and RP2D.
Detailed Description
FIH, Phase 1, open-label, multi centre, non randomised study of CB307, a trispecific
Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours.
The study will consist of a dose escalation and cohort expansion. Up to 50 patients will
participate. Patients will receive CB307 IV, until loss of clinical benefit, unacceptable
toxicity or end of study. The dose escalation may be adapted by the SRC based on clinical
experience and safety review.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Multi center open label Dose Escalation followed by cohort expansion | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Capable of understanding the written informed consent.
2. Aged at least 18 years
3. Not amenable to standard of care.
4. ECOG PS 0-1
5. Has documented histologically confirmed diagnosis of PSMA+ advanced or metastatic
solid tumours
6. Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for
castration resistant prostate cancer patients with only bone metastasis
7. Adequate organ function
Exclusion Criteria:
1. Subjects with autoimmune disease or regular immunosuppressants
2. Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of
intolerable toxicity
3. Has brain metastasis including leptomeningeal metastasis or primary brain tumour.
4. Has current or history of CNS disease
5. Has known active infection
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Time Frame: | The nature and frequency of any DLTs during the DLT-monitoring period assessed based on NCI CTCAE v5.0. up to 18 months duration. |
| Safety Issue: | |
| Description: | The objective of the study is to assess the safety and tolerability of the study drug CB307 and to determine the MTD (maximum tolerated dose) |
Secondary Outcome Measures
| Measure: | To evaluate clinical efficacy measured as progression-free survival according to RECIST v.1.1 or PCWG3 |
| Time Frame: | Progression-free survival according to RECIST v1.1 or PCWG3 up to 18 months duration; and change from baseline in anti-drug (CB307) antibodies (ADA up to 18 months duration |
| Safety Issue: | |
| Description: | To measure how well the treatment succeeds in producing the desired effect. |
| Measure: | To measure how the body processes CB307 in the body over time |
| Time Frame: | PK parameters of CB307: data collected at time point 0 at each dosing period. Up to 18 months duration. |
| Safety Issue: | |
| Description: | To evaluate the pharmacokinetic trough levels before administration of CB307 |
| Measure: | Pharmacokinetic of CB307 T1/2 |
| Time Frame: | Data collected up to 18 months duration. |
| Safety Issue: | |
| Description: | To evaluate the pharmacokinetic T1/2 after 3rd dose via IV for multiple dose levels of CB307 |
| Measure: | Pharmacokinetic of CB307 Tmax |
| Time Frame: | Data collected up to 18 months duration. |
| Safety Issue: | |
| Description: | To evaluate the pharmacokinetic Tmax after 3rd dose via IV for multiple dose levels of CB307 |
| Measure: | To measure Tumour Immune response |
| Time Frame: | Tumor response per RECIST ver 1.1 up to 18 months duration |
| Safety Issue: | |
| Description: | To determine the potential of CB307 to produce an immune response and assess the relationship with other outcome measures |
| Measure: | Relationship of CB307 to anti tumour response |
| Time Frame: | PSA response defined as a >50% decrease in PSA up to 18 months duration |
| Safety Issue: | |
| Description: | To evaluate the preliminary CB307 dose in relationship to activity of changes in tumour |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Crescendo Biologics Ltd. |
Trial Keywords
- Prostate Specific Membrane Antigen (PSMA)
- Solid Tumours
- Castration-resistant prostate cancer (CRPC)
- First in Human (FIH)
- Phase 1 Study
- CD137
- 4-1BB
- Crescendo Biologics
- CB307
- Humabody
Last Updated
June 10, 2021
