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Phase 1 Study of CTX-10726 for Advanced Cancers

This study is testing a new drug called CTX-10726 in people with advanced gastroesophageal cancer, hepatocellular carcinoma (liver cancer), endometrial cancer, or renal cell carcinoma (kidney cancer). You may be able to join if your cancer has returned, spread, or if standard treatments haven't worked or aren't available. The main goal is to find out if CTX-10726 is safe and tolerable at different doses, and to see what dose should be used in future studies. Researchers will be looking for any side effects. CTX-10726 is given as an intravenous (IV) infusion every two weeks. This is a Phase 1 study, meaning it's one of the first times this drug is being tested in humans.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving CTX-10726. It plans to enroll 70 participants and will test different doses of the drug.
What's involved
You would receive CTX-10726 as an intravenous (IV) infusion every two weeks. The study will monitor you for side effects for an average of 6 months, and up to 2 years in some cases.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety and tolerability from the first dose until 30 days after your last dose of CTX-10726, for an average of 6 months, and up to 2 years in some cases.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07419841

A Phase 1 Study of the Safety and Tolerability of CTX-10726

Recruiting
PHASE1Ages 18+InterventionalTreatment
Compass Therapeutics
~70 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:CTX-10726

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) in escalating doses
Measured over From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726, average of 6 months)
+2 more outcomes measured

Conditions

Gastroesophageal Cancer (GC)
Hepatocellular Carcinoma (HCC)
Endometrial Cancer
Renal Cell Carcinoma (RCC)

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Endometrial CarcinomaHepatocellular CarcinomaMalignant neoplasm of cardio-esophageal junction of stomachRenal Cell CarcinomaMRC1 wt AlleleMSI1 Gene

Where it's being run

5 sites across 5 states
Nebraska1
New York1
Pennsylvania1
South Carolina1
Tennessee1

Study leadership

  • Cynthia Sirard, MD · STUDY_DIRECTOR · Compass Therapeutics

Who to contact

Sarah Pilgrim
[email protected]
617-500-8099
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment.
Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab.
Hepatic function: Child -Pugh A and Child-Pugh B7.
Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed.
Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment.
Patients must have received prior treatment with platinum-based chemotherapy.
Patients must have received at least 1 cycle of platinum-based chemotherapy.
Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy.
Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment.
Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion).
Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\<3 x ULN in patients with Gilbert's syndrome), AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases).
Renal function defined as creatinine clearance ≥ 30 mL/min by Cockcroft Gault equation.
Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

What this trial measures

  • Cohort 1: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) in escalating dosesFrom first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726, average of 6 months)

    Incidence of dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

  • Cohort 1: Determine the dose(s) of CTX-10726 to be further examined in Cohort 2 and Phase 2 studiesFrom first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-10726 (average of 6 months)
  • Cohort 2: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) at dose(s) selected from Cohort 1From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726 (up to 2 years)

    Incidence of treatment-emergent adverse events (TEAEs)