Clinical trial · Interventional
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced and/or Metastatic Solid Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CB307 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multi center open label Dose Escalation followed by Cohort Expansion: Part 2A
- description
- 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.
- interventionNames
- Drug: CB307
- type
- EXPERIMENTAL
- label
- Multi center open label Dose Escalation followed by Combination Cohort Expansion : Part 2B
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWilford T, Bartlett PD, Schlag A, Jasaitis L, Pandha H, Pierce AJ, Hughes R. Solving selectivity issues in LBAs: case study using Gyrolab to quantify CB307, a bispecific Humabody in human serum. Bioanalysis. 2024;16(14):757-769. doi: 10.1080/17576180.2024.2365545. Epub 2024 Jul 3. PMID 38957926