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A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
22-001224
Category
Breast Cancer
Lung Cancer
Lymphoma
Other Cancer
Ovarian Cancer
Principal Investigator
Contact
Location
- UCLA Westwood