KB-0742 for Cancer

No longer recruiting at 29 trial locations

Overseen By Director of Clinical Operations

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kronos Bio

Must not be taking: Anti-cancer therapies, Anti-epileptics

Disqualifiers: CNS involvement, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, KB-0742, for individuals with relapsed or stubborn cancers, such as certain types of lung, breast, and ovarian cancer. The first part will determine the safest dose, while the second part will assess safety in specific cancer groups. Individuals who have faced these difficult-to-treat cancers and have no other options might be suitable candidates. As a Phase 1/Phase 2 trial, participants will be among the first to receive this new treatment and help evaluate its effectiveness in smaller groups.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop any other anti-cancer therapies, including chemotherapy, immunotherapy, or hormonal therapy, at least 4 weeks before starting the trial. The protocol does not specify about other types of medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that KB-0742 is likely to be safe for humans?

Research has shown that KB-0742 is generally well-tolerated by patients with various advanced cancers. In earlier studies, participants experienced side effects that were mostly mild to moderate and manageable. For instance, some felt tired or nauseous, but these symptoms were not severe for most.

Evidence from studies on relapsed or difficult-to-treat cancers, such as small cell lung cancer and ovarian cancer, indicates that KB-0742 is tolerated without major safety issues. While some side effects are expected, standard medical care can usually manage them.

Although the treatment is still under study, current research suggests it is safe enough to continue testing in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KB-0742 because it offers a fresh approach to treating certain challenging cancers like non-small cell lung cancer and triple-negative breast cancer. Unlike existing treatments that often target cancer cells broadly, KB-0742 is designed to specifically disrupt the activity of transcription factors, which are key players in cancer cell growth. This targeted mechanism of action could lead to more effective treatments with potentially fewer side effects, offering new hope for patients who have not responded well to current options.

What evidence suggests that KB-0742 might be an effective treatment for cancer?

Research has shown that KB-0742 holds promise in treating various types of cancer by blocking CDK9, a protein that aids cancer cell growth. Early studies found that KB-0742 is generally safe and may be effective against cancers such as small cell lung cancer, ovarian cancer, and triple-negative breast cancer. This trial will enroll participants in different cohorts to further evaluate KB-0742's effectiveness. Specifically, patients with these hard-to-treat cancers, which have recurred or resisted treatment, demonstrated some tumor shrinkage. This suggests that KB-0742 might help slow down or reduce tumors in these challenging cancers. Overall, the initial results are encouraging, but further research is needed to confirm these effects. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Part 1: Participants who meet at least 1 of the following criteria:

Willing and able to provide consent (and assent for participants between the ages of 12 to <18)

- Evaluable or measurable disease, per RECIST 1.1 or PERCIST 1.0 for solid tumors or the Lugano Classification or mSWAT for non-Hodgkin lymphoma

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Sequential cohorts of participants will receive escalating doses of KB-0742 to evaluate safety and tolerability

Up to 38 months

Cohort Expansion

Further evaluation of safety and tolerability of KB-0742 in defined participant cohorts

Up to 38 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KB-0742

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2: Cohort Expansion Experimental Treatment 1 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 high grade serous 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 Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Kronos Bio

Lead Sponsor

Trials

3

Recruited

170+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04718675

NCT04718675 | A Study of KB-0742 in Participants With ... A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) · Study ...

2. onclive.com onclive.com/view/kb-0742-exhibits-tolerable-safety-and-activity-in-relapsed-refractory-solid-tumors

KB-0742 Exhibits Tolerable Safety and Activity in Relapsed ... Tumor types of interest include small cell lung cancer; epithelial ovarian cancer; triple-negative breast cancer; non–small cell lung cancer ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40277179/

Safety and Efficacy of a Selective Inhibitor of Cyclin- ... A first-in-human, phase I trial explored the safety and preliminary efficacy of the CDK9 inhibitor KB-0742 in patients with advanced, ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT04718675

A Study of KB-0742 in Participants With Relapsed or ... Safety and efficacy of a selective inhibitor of cyclin-dependent kinase 9 (KB-0742) in patients with recurrent or metastatic adenoid cystic carcinoma.

5. asco.org asco.org/abstracts-presentations/ABSTRACT445812

Study update of the oral CDK9 inhibitor KB-0742 in ... Background: KB-0742 is a potent, and selective, oral inhibitor of CDK9 being evaluated in a phase I/II study in patients with transcriptionally addicted ...