KB-0742 for Cancer

Recruiting at 28 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

135 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+