Non Hodgkin Lymphoma Clinical Trial

A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma

Summary

Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL).

Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males or females ≥ 18 years old (Parts 1 and 2A); males or females ≥ 12 years old and with a body weight ≥ 40 kg are eligible to enroll with tumor types including soft-tissue sarcomas, Ewing's sarcoma, alveolar rhabdomyosarcoma, NUT midline carcinoma (NMC), or chordoma (Part 2B)
Willing and able to provide consent (and assent for participants between the ages of 12 to <18)

Part 1: Participants who meet at least 1 of the following criteria:

Any R/R solid tumor with, in the opinion of the investigator at the time of screening has at least 1 readily accessible biopsy site(s) and who consents to 1 baseline and 1 on-treatment biopsy. If the feasibility of obtaining biopsies changes after the participant has been consented due to changes in clinical or surgical considerations and the participant otherwise meets all eligibility criteria, they may still enroll/or continue on study.

Tumor type of interest (see list below) with measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) 1.1 or Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST) 1.0 for solid tumors or by Lugano Classification or Modified Weighted Assessment Tool (mSWAT) for NHL AND at least 1 measurable scan per one of the above criteria prior to the most recent scan to document the rate of tumor growth before the initiation of study treatment. Tumor types of interest (R/R without other available therapeutic options) are:

SCLC
Epithelial ovarian cancer, TNBC, or NSCLC
Other epithelial solid tumor with evidence of MYC copy number gain based on local testing
Diffuse large B-cell lymphoma with documented MYC translocation or Burkitt's lymphoma (as determined by local testing)
Sarcoma of histologic subtypes known to be associated with transcription factor fusion, specifically: i. Myxoid/round cell sarcoma ii. Clear cell sarcoma iii. Desmoplastic small round cell tumor iv. Low grade fibromyxoid sarcoma v. Extraskeletal myxoid chondrosarcoma vi. Ewing sarcoma vii. Alveolar rhabdomyosarcoma
Chordoma, NUT midline carcinoma, or adenoid cystic carcinoma
Part 2, Cohort A: Participants with histologically or cytologically confirmed solid tumors who have failed, are intolerant to, or are considered ineligible for standard-of-care anti-cancer treatments. Note: Part 2, Cohort A, will include participants with relapsed or refractory solid tumors including NSCLC, TNBC and ovarian cancer.
Part 2, Cohort B: Participants with histologically or cytologically confirmed tumor type of interest without access to or intolerant of other approved therapies, including SCLC.
For both Parts 1 and 2:
Access to a tumor sample for central laboratory testing
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Evaluable or measurable disease, per RECIST 1.1 or PERCIST 1.0 for solid tumors or the Lugano Classification or mSWAT for NHL
Adequate bone marrow and organ function
Recovery from treatment-related toxicities from prior therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 or to baseline level
Must agree to use highly effective birth control during the trial and for at least 3 months after the last dose of study drug; female participants cannot be pregnant or breastfeeding

Exclusion Criteria:

Any other anti-cancer therapies including chemotherapy, immunotherapy, or hormonal therapy within 4 weeks or 5 half-lives (whichever is shorter)
History of surgery (except for diagnostic purposes) or non-palliative radiotherapy within 4 weeks
History of allogeneic transplantation within 6 months
Active central nervous system (CNS) involvement by the underlying malignancy; previously treated CNS metastatic disease is permitted with magnetic resonance imaging (MRI) documentation of stable disease for at least 3 months prior to study start. Participants with SCLC with prior treatment with stereotactic radiosurgery or whole brain radiation therapy for CNS metastatic disease 2 weeks or more before study start may be considered eligible for enrollment if assessed stable and meet all other eligibility criteria.
History of stroke or intracranial hemorrhage within ≤6 months
History of seizure or seizure disorder, ie, recurrent seizures with an underlying etiology and requiring ongoing anti-epileptic medication
Current use of medications associated with seizure risk
Active infections requiring systemic antibiotic, antiviral or antifungal therapy
Known active coronavirus disease 2019 (COVID-19)
Clinically significant heart disease
Uncontrolled hypertension
Prolongation of QT interval at baseline
Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

280

Study ID:

NCT04718675

Recruitment Status:

Recruiting

Sponsor:

Kronos Bio

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 26 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
MemorialCare - Orange Coast Medical Center
Fountain Valley California, 92708, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine California, 92618, United States
Precision NextGen Oncology
Los Angeles California, 90025, United States
Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Cedars Sinai
Los Angeles California, 90048, United States
University of California, Los Angeles (UCLA)
Los Angeles California, 90095, United States
Community Health Network Community Cancer Center South
Indianapolis Indiana, 46227, United States
Community Health Network Community Cancer Center North
Indianapolis Indiana, 46250, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University
Saint Louis Missouri, 63110, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland Ohio, 44195, United States
Pennsylvania Cancer Specialists Research Institute - Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
SCRI Tennessee Oncology
Nashville Tennessee, 37203, United States
Oncology Consultants Texas Medical Center
Houston Texas, 77024, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital Universitario Quirónsalud Madrid
Madrid , 28223, Spain
Sarah Cannon Research Institute London
London , W1G 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

280

Study ID:

NCT04718675

Recruitment Status:

Recruiting

Sponsor:


Kronos Bio

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.