Clinical trial · Interventional
A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
A Phase 1/1b, Open-label, Dose-finding, First-in-human Study to Evaluate the Safety and Antitumor Activity of CX-904, an EGFR-targeted T-cell Engager in Advanced Solid Tumors (CTMX-904-101)
NCT05387265CI-TRIAL-00092071terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable 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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CX-904 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CX-904
- interventionNames
- Drug: CX-904
Primary outcomes (1)
- measure
- Patients Experiencing Dose-limiting Toxicity
- timeFrame
- 12 months
- description
- The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 30 months
- description
- ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy. * Measurable disease per RECIST 1.1 * Eastern Cooperative Oncology Group performance status of 0 or 1 * Adequate baseline laboratory values * Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-904. * Additional inclusion criteria may apply Exclusion Criteria: * History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence * Screening electrocardiogram demonstrating a mean QTcF value \> 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) \< 50% * Serious concurrent illness * History of or current active autoimmune diseases * History of myocarditis regardless of the cause * Pregnant or breast feeding * Additional exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.