A Phase I 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

Study Identifier:
CBT307-1
CT.gov Identifier:
NCT04839991
EudraCT Identifier:
2019-004584-46
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate safety, tolerability , efficacy, pharmacokinetics and pharmacodynamics of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours

To determine the maximum tolerated dose (MTD) and pharmacokinetics of CB307 and to assess preliminary anti-tumor activity in PSMA+ solid tumor patients

The dose escalation uses an accelerated titration design (ATD) and a modified continual reassessment method (mCRM) to determine the MTD and the recommended phase 2 dose (RP2D). This adaptive design allows rapid dose escalation and helps to minimise the number of patients at suboptimal doses and to determine the MTD and RP2D accurately. PSMA-PET will also be taken at baseline for the assessment of systemic PSMA status.

To evaluate the safety and efficacy of CB307,using  ANGLE's Portrait Flex assay in patients with PSMA positive solid tumours

To determine the maximum tolerated dose (MTD) and pharmacokinetics of CB307 and to assess preliminary anti-tumor activity in patients with solid tumor

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unmapped
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A
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Drug: Experimental: Multi center open label Dose Escalation followed by Combination Cohort Expansion: Part 2B
Drug: 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.
Drug: AACR 2022:
Drug: Patients will receive CB307 with pembrolizumab in expansion cohort.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Capable of understanding the written informed consent.
  • Aged at least 18 years
  • Not amenable to standard of care.
  • ECOG PS <=2
  • Has 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 metastasis
  • Adequate organ function
  • The key inclusion criteria are as follows: histologically confirmed advanced or metastatic PSMA expressing solid tumors determined by immunohistochemistry; not amenable to standard-of-care; RECIST measurable disease or increased serum PSA at baseline (for bone metastasis-only prostate cancer).
  • Cohort expansion uses the same eligibility criteria, however, at least 3 patients with castration-resistant prostate cancer harboring either BRCA1, BRCA2, ATM and/or CDK12 mutation(s) will be enrolled.
  • The key inclusion criteria are as follows: histologically confirmed advanced or metastatic PSMA expressing solid tumors determined by immunohistochemistry; not amenable to standard-of-care; RECIST measurable disease or increased serum PSA at baseline (for bone metastasis-only prostate cancer).
Exclusion criteria
  • 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
  • Patients who have discontinued previous immunotherapy due to intolerable immune-related adverse events and patients with acute infections
  • The key exclusion criteria are patients with brain metastases; patients who have discontinued previous immunotherapy due to intolerable immune-related adverse events; patients with acute infections or autoimmune diseases.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Irene Moreno
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Unmapped