RecruitingGastroesophageal Cancer (GC)Hepatocellular Carcinoma (HCC)Endometrial Cancer
A Phase 1 Study of the Safety and Tolerability of CTX-10726
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: Compass Therapeutics
You may qualify if…
- ✓ 1. Age 18 years or older.
- ✓ 2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including:
- ✓ 2a: Renal Cell Carcinoma (RCC)
- ✓ Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.
- ✓ Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment.
- ✓ Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).
- ✓ Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible.
- ✓ 2b: Hepatocellular Carcinoma (HCC)
You may not qualify if…
- ✕ 1. Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.
- ✕ 2. Prior organ transplantation.
- ✕ 3. History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
- ✕ 4. History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.
- ✕ 5. Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for \>4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.
- ✕ 6. A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.
- ✕ 7. Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.
- ✕ 8. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07419841 · last updated 2026-06-05