RECRUITING

Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.

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 tolerability to determine MTD and preliminary RP2D.In addition this study will assess the safety and efficacy of CB307 when given in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic PSMA+ castration-resistant cancer

Conditions

Advanced and/or Metastatic Solid Tumours
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Related Conditions:

Advanced and/or Metastatic Solid Tumours

Study Overview

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Study Details

Study overview

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 tolerability to determine MTD and preliminary RP2D.In addition this study will assess the safety and efficacy of CB307 when given in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic PSMA+ castration-resistant cancer

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

Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.

Condition
Advanced and/or Metastatic Solid Tumours
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington, Seattle, Washington, United States, 98109-5311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \<=2
  • 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
  • 1. Subjects with autoimmune disease or regular immunosuppressants
  • 2. Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD(L)1 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
  • 6. Part 2B only - has prior treatment with anti PD(L)1 or anti CTLA4

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Crescendo Biologics Ltd.,

K Hashimoto, STUDY_DIRECTOR, Crescendo Biologics

Study Record Dates

2024-09-25