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A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)

Phase 1, First-in-human, Open-label Dose Escalation and Cohort Expansion Study of KB-0742 in Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma

NCT04718675•Kronos Bio

View on ClinicalTrials.gov

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 including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).

Detailed Description

Part 2 cohort expansion is now enrolling Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) patients who may have one or more of these genetic alterations, BRCA 1 mutation, BRCA 2 mutation, MYC amplification/ overexpression, Homologous Recombination Deficient (HRD) positive.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. 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.
•2. 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:
•1. SCLC
•2. Epithelial ovarian cancer, TNBC, or NSCLC
•3. Other epithelial solid tumor with evidence of MYC copy number gain based on local testing
•4. Diffuse large B-cell lymphoma with documented MYC translocation or Burkitt's lymphoma (as determined by local testing)
•5. 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
+10 more criteria

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
+4 more criteria

Locations (24)

O'Neal Comprehensive Cancer Center at the University of Alabama

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

MemorialCare - Orange Coast Medical Center

Fountain Valley, California, United States

City of Hope - Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Precision NextGen Oncology

Los Angeles, California, United States

Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Community Health Network Community Cancer Center South

Indianapolis, Indiana, United States

Community Health Network Community Cancer Center North

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

February 8, 2021

Primary Completion Date

January 7, 2025

Completion Date

February 7, 2025

Last Updated

February 17, 2025

Enrollment

135

ACTUAL participants

Conditions

Relapsed Solid TumorsRefractory Solid TumorsNon-Hodgkin LymphomaHGSOCPlatinum Resistant High Grade Serous Ovarian Cancer

Interventions

KB-0742

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

View study

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: February 17, 2025Data 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 Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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