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KB-0742 for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Kronos Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- 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 non-Hodgkin lymphoma 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:

Small cell lung cancer (SCLC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial is testing the safety of KB-0742 in cancer patients.

Who is the study for?

Adults and teens from age 12 with certain advanced cancers (like lung, breast, ovarian cancer, or non-Hodgkin lymphoma) that have come back or didn't respond to treatment can join. They must be healthy enough for daily activities (ECOG PS 0-1), have a tumor that can be measured, recovered from past treatments' side effects, not pregnant/breastfeeding, and agree to use birth control.Check my eligibility

What is being tested?

KB-0742 is being tested in two parts: first to find the safest dose in people with various advanced cancers and then to see how well it works in specific groups of patients. The trial involves taking samples before and during treatment to study the drug's effect on tumors.See study design

What are the potential side effects?

While specific side effects of KB-0742 are not listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, diarrhea or constipation. Side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with small cell lung cancer.

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My lymphoma is confirmed to have a specific genetic change.

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I have ovarian, triple negative breast, or non-small cell lung cancer.

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I am fully active or can carry out light work.

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I agree to two biopsies for my relapsed or refractory solid tumor.

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I can provide a sample of my tumor for testing.

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My sarcoma has a specific genetic feature found in a test.

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My cancer is either chordoma, NUT midline carcinoma, or adenoid cystic carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 and Part 2: Incidence of Adverse Events (AEs)

Part 1 and Part 2: Number of Participants with Dose Limiting Toxicity (DLT) of KB-0742

Part 1: Maximally Tolerated Dose (MTD) of KB-0742

+1 more

Secondary outcome measures

Part 1 and Part 2: Disease Control Rate

Part 1 and Part 2: Duration of Disease Control

Part 1 and Part 2: Duration of Response (DOR)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Cohort ExpansionExperimental Treatment1 Intervention

Following identification of the contingent recommended Phase 2 dose (RP2D) in Part 1, the following expansion cohorts will be enrolled: Cohort A: Participants with R/R non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and ovarian cancer. Cohort B: Participants with R/R small cell lung cancer (SCLC), NUT midline carcinomas (NMC), adenoid cystic carcinoma (ACC), chordoma and soft tissue sarcomas associated with transcription factor fusion.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Sequential cohorts of participants will receive escalating doses of KB-0742.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kronos BioLead Sponsor

2 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

KB-0742 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04718675 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Part 2: Cohort Expansion, Part 1: Dose Escalation

Non-Hodgkin's Lymphoma Clinical Trial 2023: KB-0742 Highlights & Side Effects. Trial Name: NCT04718675 — Phase 1 & 2

KB-0742 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04718675 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available vacancies for participants of this clinical research?

"Per the listing on clinicaltrials.gov, this medical experiment is currently recruiting participants. The study went live on February 8th 2021 with its most recent update being issued November 15th 2022."

Answered by AI

How might KB-0742 be potentially hazardous to individuals?

"The safety rating for KB-0742 is a 1 as this drug has only been through its initial round of clinical trials and there exists minimal data regarding both efficacy and safety."

Answered by AI

How many participants are enrolled in the experiment to date?

"To meet the requirements of this medical trial, 120 participants with matching eligibility must enroll. There are two major locations where patients can access this clinical study - Massachusetts General Hospital (Boston) and South Texas Accelerated Research Therapeutics (San Antonio)."

Answered by AI

How many medical facilities have been designated for this clinical investigation?

"Currently, 7 clinics are hosting this clinical trial: Boston, San Antonio and Saint Louis being the most prominent. To reduce travel demands if you choose to join, favour registering at a medical centre closest to your residence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Dose Escalation and Cohort Expansion Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718675.