Trials / Recruiting
RecruitingNCT07419841
A Phase 1 Study of the Safety and Tolerability of CTX-10726
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Compass Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.
Detailed description
This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics profile of CTX-10726 monotherapy. Preliminary anti-tumor activity of CTX-10726 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate four dose levels (0.3-10.0mg/kg) of CTX-10726 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-10726 as an IV infusion at dose(s) based on data from the Dose Escalation Cohort.
Conditions
- Gastroesophageal Cancer (GC)
- Hepatocellular Carcinoma (HCC)
- Endometrial Cancer
- Renal Cell Carcinoma (RCC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTX-10726 | Intravenous (IV) infusion (0.3-10.0mg/kg) every two weeks. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-11-01
- First posted
- 2026-02-19
- Last updated
- 2026-04-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07419841. Inclusion in this directory is not an endorsement.