Actively Recruiting
A Phase 1 Study of the Safety and Tolerability of CTX-10726
Led by Compass Therapeutics · Updated on 2026-05-13
70
Participants Needed
4
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of the Safety and Tolerability of CTX-10726
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Confirmed diagnosis of locally advanced unresectable or metastatic renal cell carcinoma, hepatocellular carcinoma, gastroesophageal cancer, or endometrial cancer that is relapsed, refractory to standard therapy, or without effective standard treatment.
- For renal cell carcinoma: clear cell component, progressed after at least 2 doses of PD-1/PD-L1 therapy, and received at least one tyrosine kinase inhibitor regimen.
- For hepatocellular carcinoma: progressed after at least 2 doses of PD-1/PD-L1 therapy, received specified regimens, and hepatic function within Child-Pugh A or B7.
- For gastroesophageal cancer: progressed after at least 2 doses of PD-1/PD-L1 therapy and prior platinum-based chemotherapy.
- For endometrial cancer: received at least 1 cycle of platinum-based chemotherapy, persistent lesions after standard treatment, and progressed after at least 2 doses of PD-1/PD-L1 therapy if MSI-high or dMMR.
- Measurable disease per RECIST 1.1 without prior radiation at tumor sites.
- ECOG performance status 0-1.
- Adequate bone marrow, hepatic, renal, and cardiac function.
- Female patients must be surgically sterile, postmenopausal, or use two forms of birth control; males must also use reliable contraception during and after the study.
- Negative pregnancy test for women of childbearing potential.
- Recovery from prior anticancer therapy toxicities to Grade 2 or less.
- Ability to understand and comply with study requirements.
- Signed informed consent before screening.
You will not qualify if you...
- History of severe or life-threatening immune-related adverse reactions to prior PD-1/PD-L1 therapy leading to treatment discontinuation.
- Prior organ transplantation.
- Blood clot or stroke within 6 months before starting treatment.
- Other cancers within 3 years, except certain skin or cervical cancers treated successfully.
- Symptomatic or uncontrolled brain metastases or leptomeningeal disease; stable treated brain metastases allowed.
- Symptomatic pleural, abdominal, or pericardial effusions needing repeated management within 14 days.
- Tumors surrounding major blood vessels or with necrosis increasing bleeding risk.
- Severe wounds, active ulcers, or untreated fractures.
- Significant bleeding disorders or severe coagulopathy.
- Therapeutic anticoagulant or thrombolytic use within 14 days, except prophylactic low molecular weight heparin.
- Use of high-dose aspirin or NSAIDs within 14 days.
- Uncontrolled diabetes or high blood pressure despite medication.
- Pregnant or breastfeeding women.
- Active hepatitis B, C, or uncontrolled HIV infection.
- Recent attenuated vaccination within 4 weeks before screening or planned during study.
- Systemic immunosuppressive therapy within 7 days before treatment, excluding allowed corticosteroids.
- Active autoimmune disease requiring chronic immunosuppression.
- Lung diseases including pulmonary fibrosis, pneumonia, or respiratory failure.
- Other significant medical conditions interfering with study participation as determined by investigators.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
2
START New York
Lake Success, New York, United States, 11042
Actively Recruiting
3
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
Not Yet Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
S
Sarah Pilgrim
CONTACT
T
Talia Fountain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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