Recruiting
Phase 1

CB307

Sponsor:

Crescendo Biologics Ltd.

Code:

NCT04839991

Conditions

Advanced and/or Metastatic Solid Tumours

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CB307

Study Details

Brief summary:

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

Study ID

NCT04839991

Start date

Jun 8, 2021

Status verified date

Nov, 2023

Completion date

Sep 25, 2024

Anticipated

Primary completion date

Jul 25, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 <=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

Exclusion Criteria:

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A

Patients will receive CB307 IV infused every 7 days. Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2A arm will enrol patients with PSMA+ solid tumours. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months.

experimental: Multi center open label Dose Escalation followed by Combination Cohort Expansion : Part 2B

Patients will receive CB307 IV infused every 7 days in combination with KEYTRUDA® (pembrolizumab) IV infused every 21 days . Duration of treatment cycle is 21 days. Once the Dose Escalation phase (Part 1) is completed Cohort Expansion phase (Part 2) will begin. Part 2B arm will enrol patients with PSMA+ metastatic castration-resistant prostate cancer. Treatment will continue until loss of clinical benefit, intolerable toxicity, withdrawal of consent or the study is stopped. Estimated study duration is 20 months.

Interventions

CB307

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

Primary outcome 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 20 months duration. ]
  • Number of participants with treatment-related adverse events with CB307 in combination with pembrolizumab as assessed by CTCAE v5.0 [ Time Frame: The nature and frequency of any DLTs during the DLT-monitoring period for participants with combination therapy, assessed based on NCI CTCAE v5.0. up to 20 months duration. ]

Central Contacts and Locations

Central contacts

MD

01223497140Clinicaltrials@crescendobiologics.com

MD

012234947140info@crescendobiologics.com

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98109-5311

Contacts

Jessica Hawley

jehawley@uw.edu

More Information

Sponsor

Crescendo Biologics Ltd.

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

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®
  • HSA
  • Pembrolizumab
  • KEYTRUDA®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Crescendo Biologics Ltd. on 2023-11-18.