Actively Recruiting
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies
Led by Compass Therapeutics · Updated on 2026-06-05
70
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label, first-in-human study to evaluate CTX-10726 monotherapy in patients with metastatic or locally advanced cancers, including gastroesophageal cancer, hepatocellular carcinoma, endometrial cancer, and renal cell carcinoma. The study aims to assess the safety, tolerability, immune response, and how the drug behaves in the body. Early effects on tumor response will also be explored. The study has two parts: a dose escalation group and a dose expansion group. In the dose escalation phase, participants receive increasing doses of CTX-10726 through intravenous infusion every two weeks, with doses ranging from 0.3 to 10.0 mg/kg. In the dose expansion phase, patients receive doses selected based on results from the first group, also given every two weeks by IV infusion. Participants will be involved in regular treatments every two weeks and monitored through various tests, including tumor assessments, blood tests for drug levels and immune response, and safety evaluations. Researchers will track side effects, tumor response, and survival outcomes during the treatment period and follow up for up to two years. The study also includes detailed monitoring of organ function and overall health throughout participation.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed locally advanced unresectable or metastatic disease relapsed/refractory to standard therapy or without effective standard therapy
- Renal cell carcinoma patients must have clear cell component, progressed after PD-1/PDL1 treatment, and received at least one tyrosine kinase inhibitor regimen
- Hepatocellular carcinoma patients must have progressed after PD-1/PDL1 treatment and received specified regimens with Child-Pugh A or B7 liver function
- Gastroesophageal cancer patients must have progressed after PD-1/PDL1 treatment and received platinum-based chemotherapy
- Endometrial cancer patients must have received platinum-based chemotherapy and meet specified criteria including MSI-high or dMMR tumors
- Measurable disease per RECIST 1.1 with no prior radiation to tumor sites
- ECOG performance status 0-1
- Adequate bone marrow, hepatic, renal, and cardiac function
- Female patients must be surgically sterile, postmenopausal, or use effective birth control; male patients must be sterile or use reliable contraception
- Negative pregnancy test for women of childbearing potential within 7 days before dosing
- Recovery from prior anticancer therapy toxicities to Grade 2 or less (excluding alopecia)
- Capable of understanding and complying with protocol requirements
- Signed informed consent form before any study procedures
You will not qualify if you...
- Prior severe or life-threatening immune-related adverse reactions to PD-1 or PD-L1 therapy leading to discontinuation
- Prior organ transplantation
- History of arterial or venous thrombosis, stroke, or transient ischemic attack within 6 months before dosing
- Other cancers within 3 years except certain skin or cervical cancers successfully treated
- Symptomatic or uncontrolled brain metastases or leptomeningeal disease unless stable without corticosteroids or seizure meds for over 4 weeks
- Symptomatic or frequently managed pleural, abdominal, or pericardial effusions within 14 days before dosing
- Tumors surrounding major blood vessels or necrotic causing bleeding risk
- Severe unhealed wounds, active ulcers, or untreated fractures
- Significant bleeding disorders or severe coagulopathy
- Therapeutic anticoagulant or thrombolytic treatment within 14 days before dosing (prophylactic low molecular heparin allowed)
- Aspirin over 325 mg/day or other NSAIDs within 14 days before dosing
- Uncontrolled diabetes despite medication
- Poorly controlled hypertension above 140/90 mmHg despite medication
- Pregnant or lactating women
- Active hepatitis B, hepatitis C, or HIV infection unless controlled as specified
- Recent attenuated vaccination within 4 weeks before screening or planned during study
- Systemic immunosuppressive therapy within 7 days before treatment except permitted corticosteroids
- Active autoimmune disease or requiring chronic steroids above 10 mg/day prednisone equivalent
- Active or prior lung diseases such as pulmonary fibrosis or severe respiratory distress
- Other medical conditions interfering with study conduct including certain heart diseases and prolonged QTc interval over 480 msec
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 2-week cycles for an average of 6 months in the Dose Escalation Cohort and up to 2 years in the Dose Expansion Cohort
Participants receive CTX-10726 as an intravenous (IV) infusion every two weeks to evaluate safety, tolerability, and preliminary anti-tumor activity.
Infusions every 2 weeks with regular assessments throughout treatment
Duration - 30 days to up to 2 years after last dose
Participants are monitored for safety and treatment effects for 30 days after the last dose of CTX-10726, with some participants followed for up to 2 years.
Periodic visits for safety and response assessments during follow-up
Trial Site Locations
Total: 5 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
3
START New York
Lake Success, New York, United States, 11042
Actively Recruiting
4
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
S
Sarah Pilgrim
T
Talia Fountain
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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