Clinical trial · Interventional
First In Human Study of CX-801 in Advanced Solid Tumors
An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
NCT06462794CI-TRIAL-00124515recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid 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 |
|---|---|---|---|
| CX-801 | Drug | — | UNRESOLVED |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CX-801
- interventionNames
- Drug: CX-801
- type
- EXPERIMENTAL
- label
- CX-801 + pembrolizumab
- interventionNames
- Drug: CX-801
- Drug: pembrolizumab
Primary outcomes (2)
- measure
- Safety and tolerability of CX-801 as monotherapy and combination therapy
- timeFrame
- 44 months
- description
- The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Measurable disease per RECIST v1.1 * Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue * Adequate organ function * Additional inclusion criteria may apply Exclusion Criteria: * Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated * Known active central nervous system (CNS) involvement by malignancy * Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event * Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment * Investigational drug or device within 4 weeks prior to first dose of study treatment * Radiation within 2 weeks prior to first dose of study treatment * Serious concurrent illness * Pregnant or breast feeding * Additional exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.