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 ≥ 16 years old (Part 2B)
Willing and able to provide consent (and assent for participants between the ages of 16-18)

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

Any relapsed/refractory (R/R) solid tumor with readily accessible biopsy sites and consenting to 1 baseline and 1 on-treatment biopsy.

Tumor type of interest (see list below) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) AND at least 1 RECIST measurable scan 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:

Small cell lung cancer (SCLC)
Epithelial ovarian cancer or non-small cell lung cancer (NSCLC) with documented MYC copy number gain or overexpression as determined in a certified laboratory using a CAP/CLIA (or equivalent) assay or as assessed in a central laboratory designated by the sponsor
Diffuse large B-cell lymphoma with documented MYC translocation or Burkitt's lymphoma (as determined by local testing)
Sarcoma with documented transcription factor fusion (as determined by local testing)
Chordoma, NUT midline carcinoma, or adenoid cystic carcinoma
Part 2A: 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: All Part 2, Cohort A, patients will require documented MYC copy number gain or overexpression as determined in a certified laboratory using a CAP/CLIA (or equivalent) assay or as assessed in a central laboratory designated by the sponsor. This cohort will include 7-10 patients with one of the following malignancies: NSCLC, triple-negative breast cancer, ovarian cancer, and lymphoma.

Part 2B: Histologically or cytologically confirmed SCLC or soft tissue sarcomas with defined transcription factor oncogenic drivers
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 for solid tumors or the Lugano Classification for non-Hodgkin lymphoma
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
History of stroke or intracranial hemorrhage within ≤6 months
History of seizure disorder, ie, recurrent seizures with an underlying etiology and requiring ongoing anti-epileptic medication
Current use of medications associated with seizure risk unless approved by Medical Monitor
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:

120

Study ID:

NCT04718675

Recruitment Status:

Recruiting

Sponsor:

Kronos Bio

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Dr. Villalona, MD
Contact
Cedars Sinai
Los Angeles California, 90048, United States More Info
Dr. Mita
Contact
800-233-2771
University of California, Los Angeles (UCLA)
Los Angeles California, 90095, United States More Info
Noah Federman, MD
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Dr. Gregory Cote
Contact
Washington University
Saint Louis Missouri, 63110, United States More Info
Dr. Van Tine
Contact
SCRI Tennessee Oncology
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Isabel Jimenez, RN, MSN
Contact
210-593-5265
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04718675

Recruitment Status:

Recruiting

Sponsor:


Kronos Bio

How clear is this clinincal trial information?

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