Clinical trial · Interventional
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
- 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)
The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4. The main questions it aims to answer are: What is the the safe and effective dose of CRB-701? What cancers can be treated effectively with CRB-701? Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701. They will have blood tests, CT or MRI Scans, and other assessments to measure whether CRB-701 has an effect on tumors.
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 |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 | Drug | — | UNRESOLVED |
| CRB-701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (15)
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation - CRB-701 Dose Level 1
- description
- CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1
- interventionNames
- Drug: CRB-701
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation - CRB-701 Dose Level 2
- description
- CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1
- interventionNames
- Drug: CRB-701
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation - CRB-701 Dose Level 3
- description
- CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed having exhausted all appropriate lines of therapy or have no other standard therapy with proven clinical benefit. In Part C, HNSCC participants may enroll as first-line therapy. Exclusion Criteria: * Active of uncontrolled CNS metastases * History of solid tumors other than the diseases under study * History of and/or current cardiovascular events or conditions in the previous 6 months * Pre-existing \>/= Grade 2 neuropathy * Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy * Active ocular disease at baseline * Chronic severe liver disease or live cirrhosis * Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study * Other significant cormorbidities.
References
Publications (0)
Data not yet available