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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1 Study of the Safety and Tolerability of CTX-10726 (NCT07419841) is a Phase 1 interventional studying Gastroesophageal Cancer (GC) and Hepatocellular Carcinoma (HCC), sponsored by Compass Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Gastroesophageal Cancer (GC), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastroesophageal Cancer (GC) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 years or older. 2. Patients must have a diagnosed by tissue sample (biopsy-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) - diagnosed by tissue sample (biopsy-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) - 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 or atezolizumab+bevacizumab. - 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. 2c. Gastroesophageal Cancer (GC) - 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. 2d: Endometrial Cancer (EC) - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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) * 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 or atezolizumab+bevacizumab. * 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. 2c. Gastroesophageal Cancer (GC) * 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. 2d: Endometrial Cancer (EC) * 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. 3\. Patients must have measurable disease per RECIST 1.1. Tumor sites that are considered measurable must not have received prior radiation. 4\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5\. Adequate organ function including: * 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, 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%. 6\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment. 7\. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-10726. 8\. Prior anticancer therapy \> 28 days (or 2 half-lives for proteins, whichever is longer), radiotherapy \> 7 days (concurrent localized palliative radiotherapy is allowed during CTX-10726 treatment), therapeutic surgical intervention \> 21 days, blood transfusion \> 14 days, or biopsy or minor surgery (excluding placement of vascular access devices) \> 7 days prior to the first dose of CTX-10726. 9\. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2. 10\. Capable of understanding and complying with protocol requirements 11\. Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed. Exclusion Criteria: 1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment. 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. Known, symptomatic central nervous system (CNS) and brain metastasis. 6. A pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc). 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. 9. A history of significant bleeding tendency or severe coagulopathy. 10. Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin is allowed. 11. Current or recent use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose. 12. Uncontrolled diabetes mellitus (HbA1c \>8%) on standard therapy. 13. The presence of poorly controlled hypertension (systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\]) \>140/90 mmHg (eg, patient with SBP/DBP \> 140/90 mmHg despite the best care including optimizing the anti-hypertensive medication regimen. 14. Pregnant or lactating WOCBP. 15. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll. 1. Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \< 1000 copies /ml (200 IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required. 2. HIV-infected subjects who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection. 16. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection). 17. Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period. 18. Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed. 19. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor. 20. Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, severe respiratory distress, pulmonary insufficiency or continuous oxygenation. 21. Other medical conditions in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including: a. Congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias. b. QTc interval (using Fridericia correction calculation) \> 480 msec.

Treatments Being Tested

DRUG

CTX-10726

Intravenous (IV) infusion (0.3-10.0mg/kg) every two weeks.

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nebraska Cancer Specialists
Omaha, Nebraska, United States
START New York
Lake Success, New York, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07419841), the sponsor (Compass Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07419841 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07419841?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07419841?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07419841. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07419841. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.