Clinical trial · Interventional
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated 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)
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBA-1535 | Drug | — | UNRESOLVED |
| CBA-1535+Pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: CBA-1535 (single agent therapy)
- description
- Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle.
- interventionNames
- Drug: CBA-1535
- type
- EXPERIMENTAL
- label
- Part 2: CBA-1535+Pembrolizumab
- description
- Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle.
- interventionNames
- Drug: CBA-1535+Pembrolizumab
Primary outcomes (2)
- measure
- Dose limiting toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who provide voluntary written informed consent to participate in the study * ECOG performance status: \<= 1 * Patients with 3 months or longer life expectancy * Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy Exclusion Criteria: * Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment * Patients who received anti-cancer drug within 14 days prior to enrollment * Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug
References
Publications (0)
Data not yet available