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A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

A Phase 1, Open-Label, Dose Escalation Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of SNDX-6352 Monotherapy and SNDX-6352 in Combination With Durvalumab in Patients With Unresectable, Recurrent, Locally-Advanced, or Metastatic Solid Tumors

NCT03238027•Syndax Pharmaceuticals

View on ClinicalTrials.gov

Summary

A Phase 1 dose escalation study to determine if axatilimab as monotherapy and axatilimab in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further investigation in patients with solid tumors.

Detailed Description

This is an open label, multi-center Phase 1 study consisting of Phase 1a and Phase 1b. The study will evaluate axatilimab monotherapy (in Phase 1a) and axatilimab combined with durvalumab (in Phase 1b) in patients with advanced solid tumors which must have progressed following prior treatment and have no standard therapy alternatives left (i.e., patients must not be candidates for regimens known to provide clinical benefit). The primary objective will be to determine the MTD and/or RP2D of axatilimab as monotherapy (Phase 1a) and in combination with durvalumab (Phase 1b) as evaluated by the incidence of AEs that are defined as DLTs. In both study phases, a standard "3+3" dose escalation schema will be used to determine an MTD with 3-6 evaluable patients enrolled per dose level. The RP2D will be determined based on data from the dose escalation patients as reviewed by the Safety Review Committee (SRC; comprised of investigators and the Sponsor).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients meeting all of the following criteria are considered eligible to participate in the study:
•1. Signed written informed consent form (ICF).
•2. Male or female patients aged ≥18 years.
•3. Patients with histopathologically confirmed unresectable, recurrent, locally advanced, or metastatic solid tumors, with evaluable disease and must have progressed following prior treatment and have no standard therapy alternatives left (i.e., patients must not be candidates for regimens known to provide clinical benefit).
•4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at the study enrollment.
•5. Has adequate organ and bone marrow function within 21 days before enrollment as defined below:
•a. Hematological laboratory values: i. Absolute Neutrophil Count (ANC) ≥1.5 × 10\^9/L ii. Platelets ≥100 × 10\^9/L iii. Hemoglobin ≥9 g/dL b. Renal laboratory values: i. Creatinine ≤1.5 times the Upper Limit of Normal (ULN) OR ii. Measured or calculated (per institutional standard) creatinine clearance (CrCl) ≥60 mL/min according to the Cockcroft-Gault formula or measured 24-hour creatinine clearance (or local institutional standard measure) for patient with creatinine level \> 1.5 times institutional ULN.
•iii. Glomerular filtration rate may be used instead of creatinine or CrCl. c. Hepatic laboratory values: i. Total bilirubin ≤1.5 times ULN or ii. Direct bilirubin ≤ULN for patients with total bilirubin \>1.5 times ULN iii. AST and ALT ≤2.5 times ULN d. Creatine kinase ≤ ULN
•6. Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade ≤1 (except alopecia) per NCI CTCAE v5.0 If a patient underwent major surgery or radiation therapy of \>30 Gray, the patient must have recovered from the toxicity and/or complications from the intervention.
•Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
+6 more criteria

Exclusion Criteria

•1. Diagnosis of immunodeficiency or receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug.
•a. Exceptions: 1) The use of physiologic doses of corticosteroids (i.e., ≤10 mg per day of equivalent prednisone) is allowed; 2) Steroids with no or minimal systemic effect (topical, inhalation) are allowed; 3) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; (4) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•2. Previously treated with a CSF-1, CSF-1R, and/or IL-34-blocking agents
•3. Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
•4. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the patient's best interest to participate, in the opinion of the treating Investigator, including, but not limited to:
•1. Active or prior documented autoimmune or inflammatory disorders (see Appendix 3 for complete list).
•2. History of active primary immunodeficiency
•3. Known active or latent tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).
•4. Myocardial infarction or arterial thromboembolic events within 6 months prior to enrollment or severe or unstable angina, New York Heart Association (NYHA) (see Appendix 2) Class III or IV disease, or a QTc interval \> 470 msec. History of QTc prolongation, ventricular fibrillation, ventricular tachycardia or Torsades de Pointes (TdP).
•5. Symptomatic congestive heart failure, cardiac arrhythmia, uncontrolled hypertension or diabetes mellitus.
+23 more criteria

Locations (5)

Honor Health

Scottsdale, Arizona, United States

Johns Hopkins University

Baltimore, Maryland, United States

Oregon Health and Science University

Portland, Oregon, United States

NEXT Oncology

San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Key Dates

Start Date

September 1, 2017

Primary Completion Date

November 20, 2020

Completion Date

November 20, 2020

Last Updated

May 17, 2024

Enrollment

ACTUAL participants

Conditions

Solid TumorMetastatic TumorLocally Advanced Malignant NeoplasmUnresectable Malignant Neoplasm

Interventions

Axatilimab

DRUG

Durvalumab

DRUG

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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