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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 belowSelect...
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)
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 moreSecondary 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 moreTrial 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.
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Who is running the clinical trial?
Kronos BioLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a transplant from another person within the last 6 months.I am taking medication that could increase my risk of seizures, but it's approved by a medical professional.I have been diagnosed with HIV, hepatitis B, or hepatitis C.I have not had surgery or non-palliative radiotherapy in the last 4 weeks.I have a seizure disorder and am on medication for it.I have not had a stroke or brain bleed in the last 6 months.I do not have any severe ongoing health issues affecting my kidneys, liver, blood, stomach, hormones, lungs, brain, or mental health.I have a specific type of cancer (like SCLC or sarcoma) without treatment options or cannot tolerate them.I am currently on medication for an active infection.I have been diagnosed with small cell lung cancer.I am at least 18 years old, or over 12 with a specific type of cancer and weigh more than 40 kg.My lymphoma is confirmed to have a specific genetic change.I have recovered from side effects of previous cancer treatments.My cancer has spread to my brain but has been stable for at least 3 months.My cancer is either NSCLC, triple-negative breast cancer, or ovarian cancer and has not responded to treatment.I have ovarian, triple negative breast, or non-small cell lung cancer.I haven't had cancer treatments like chemo, immunotherapy, or hormone therapy in the last 4 weeks.I currently have an active COVID-19 infection.I am fully active or can carry out light work.I agree to two biopsies for my relapsed or refractory solid tumor.I have a solid tumor and cannot use standard cancer treatments.I can provide a sample of my tumor for testing.My sarcoma has a specific genetic feature found in a test.My high blood pressure is not under control.My organs and bone marrow are working well.I have a serious heart condition.My cancer is either chordoma, NUT midline carcinoma, or adenoid cystic carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Cohort Expansion
- Group 2: Part 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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