Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Relapsed Solid Tumors, Refractory Solid Tumors, Non-Hodgkin Lymphoma, KB-0742, CDK9 Inhibitor, Lymphoma, Neoplasms, Lymphoma, Non-Hodgkin

Eligibility

You can join if…

Open to people ages 16 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • Cedars Sinai accepting new patients
    Los Angeles California 90048 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kronos Bio
ID
NCT04718675
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated