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

NCT07419841 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CTX-10726-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

Brief Summary

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

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

Outcome Measures

Primary Outcomes (3)

• Cohort 1: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) in escalating doses

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

  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)

• Cohort 1: Determine the dose(s) of CTX-10726 to be further examined in Cohort 2 and Phase 2 studies

  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)

• Cohort 2: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) at dose(s) selected from Cohort 1

  Incidence of treatment-emergent adverse events (TEAEs)

  From 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)

Secondary Outcomes (15)

• Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Baseline until confirmed disease progression (up to 2 years)

• Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  From the date of first confirmed complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease (up to 2 years)

• Disease Control Rate (DCR) percentage of patients with best overall response of CR, PR, or SD as per RECIST version 1.1

  From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)

• Clinical Benefit Rate (CBR) percentage of patients with best overall response of CR, PR, or SD for ≥ 6 months as per RECIST version 1.1

  From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)

• Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  From first dose of CTX-10726(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)

Study Arms (2)

Dose Escalation Cohort 1

EXPERIMENTAL

Escalating doses of CTX-10726

Drug: CTX-10726

Dose Expansion Cohort 2

EXPERIMENTAL

Dose of CTX-10726 depending on Cohort 1 data

Drug: CTX-10726

Interventions

CTX-10726 DRUG

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

Dose Escalation Cohort 1; Dose Expansion Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• 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:
• a: 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.
• b: 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, 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.
• c. 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.

You may not qualify if:

• Prior organ transplantation.
• History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
• 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.
• 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.
• 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.
• 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.
• The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.
• A history of significant bleeding tendency or severe coagulopathy.
• Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg/day) is allowed.
• Current or recent use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.
• Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.
• 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 ≥3 anti-hypertensive medications within 7 days of dosing with CTX-10726).
• Pregnant or lactating WOCBP.
• 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.
• Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection).

Sponsors & Collaborators

• Compass Therapeutics: lead

Study Sites (5)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

START New York

Lake Success, New York, 11042, United States

RECRUITING

Prisma Health Cancer Institute

Greenville, South Carolina, 29605, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Endometrial Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Cynthia Sirard, MD

  Compass Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Sarah Pilgrim

CONTACT

617-500-8099; ctx-10726-001@compasstherapeutics.com

Talia Fountain

CONTACT

617-500-8099; ctx-10726-001@compasstherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-02

Locations

US (5)