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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kronos Bio

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 patients between the ages of 16-18)

• Part 1: Histologically or cytologically confirmed solid tumors or non-Hodgkin lymphoma, which have failed, are intolerant to or are considered ineligible for standard-of-care anti-cancer treatments

• Part 2A: Histologically or cytologically confirmed solid tumors which have failed, are intolerant to or are considered ineligible for standard-of-care anti-cancer treatments; documentation of MYC genomic amplification/overexpression is required

• Part 2B: Histologically or cytologically confirmed 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 Response Evaluation Criteria in Solid Tumors (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

• 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