A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Re⦠(NCT04718675) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)
Stopped: Due to lack of safety and futility
United States135 participantsStarted 2021-02-08
Plain-language 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).
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
β. 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.
β. 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:
β. SCLC
β. Epithelial ovarian cancer, TNBC, or NSCLC
β. Other epithelial solid tumor with evidence of MYC copy number gain based on local testing
β. Diffuse large B-cell lymphoma with documented MYC translocation or Burkitt's lymphoma (as determined by local testing)
β. 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
What they're measuring
1
Part 1 and Part 2: Incidence of Adverse Events (AEs)
Timeframe: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 38 months)
2
Part 1 and Part 2: Number of Participants with Dose Limiting Toxicity (DLT) of KB-0742
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
3
Part 1: Maximally Tolerated Dose (MTD) of KB-0742
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
4
Part 1: Recommended Phase 2 Dose (RP2D) of KB-0742
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days