KQB198 for Blood Cancers

Recruiting at 31 trial locations

Overseen By Kumquat Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kumquat Biosciences Inc.

Must be taking: Dasatinib

Disqualifiers: CML accelerated, Intestinal disease, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new drug, KQB198, can help treat certain blood cancers, specifically advanced hematologic malignancies. Researchers seek to discover whether KQB198, alone or with other cancer drugs, can safely shrink tumors. Participants will take the drug daily and visit the clinic regularly. This trial suits adults with chronic phase CML (a type of blood cancer) who have tried at least two other treatments without success or with adverse effects. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are in Part 2, Cohort A, you must be on dasatinib before joining the study.

Is there any evidence suggesting that KQB198 is likely to be safe for humans?

Research on KQB198 remains in the early stages, so limited information exists on its safety in humans. Although specific safety results from previous studies are unavailable, KQB198 is undergoing its first round of human trials. This phase focuses on ensuring the treatment's safety and determining the correct dose.

As KQB198 is in an early trial phase, researchers closely monitor participants for handling and potential side effects. If KQB198 has approval for other uses, it might suggest some level of safety, but sources do not mention this. Participants will be closely observed to assess their reactions to the treatment. Researchers prioritize safety as they gather more information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

KQB198 is unique because it targets specific pathways involved in blood cancers, potentially offering a more precise treatment option compared to traditional chemotherapy, which often affects both healthy and cancerous cells. Researchers are excited about KQB198 because it may reduce side effects and improve patient outcomes by directly targeting cancer cells. Additionally, KQB198's mechanism allows for flexibility in treatment, such as being used alone or in combination with other therapies, which could optimize effectiveness for different patient needs.

What evidence suggests that KQB198 might be an effective treatment for blood cancers?

Research has shown that KQB198 is under study as a potential treatment for advanced blood cancers. Early results suggest that KQB198 might shrink tumors, either alone or in combination with Dasatinib. Participants in this trial will be assigned to different treatment arms, including monotherapy and combination therapy with Dasatinib, to evaluate effectiveness. This treatment targets cancer cells and may inhibit their growth. Although limited data exists on its efficacy in humans, earlier studies on similar conditions have shown promise. This trial aims to further understand how KQB198 can benefit patients with these cancers. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced blood cancers. Participants will take KQB198 daily, alone or in combination with another anti-cancer drug, Dasatinib. They must visit the clinic frequently for monitoring.

Inclusion Criteria

My organs are working well.

I have chronic phase CML, have been treated with dasatinib, and it's not working well.

I have CML in chronic phase, tried at least 2 TKIs, and can't use other treatments.

Exclusion Criteria

My leukemia is in an advanced stage.

I have a history of lung scarring or fibrosis.

I have not been treated with drugs similar to KQB198 before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take KQB198 daily, alone or in combination with another anti-cancer drug

6 months

8 visits in the first 8 weeks, then once every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Long-term follow-up

Participants are monitored for long-term safety and efficacy outcomes

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• KQB198

Trial Overview The study tests the safety and effectiveness of a new treatment, KQB198, both as a standalone therapy and combined with Dasatinib. It aims to find the safe dose and measure tumor response to these treatments.

How Is the Trial Designed?

Group I: Monotherapy Dose Expansion - RP2D -1 Experimental Treatment 1 Intervention

Group II: Monotherapy Dose Expansion - RP2D Experimental Treatment 1 Intervention

Group III: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Group IV: Combo Therapy Dose Expansion - RP2D-1 Experimental Treatment 2 Interventions

Group V: Combo Therapy Dose Expansion - RP2D Experimental Treatment 2 Interventions

Group VI: Combo Therapy Dose Escalation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Kumquat Biosciences Inc.

Lead Sponsor

Trials

3

Recruited

350+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06645886

A Study to Investigate the Safety and Efficacy of KQB198 ... The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about the safety of KQB198.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/547727

A Study to Investigate the Safety and Efficacy of KQB198 ... The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08353

A Study to Investigate the Safety and Efficacy of KQB198 ... The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198.

4. withpower.com withpower.com/trial/phase-1-adults-9-2024-a7d17

KQB198 for Blood Cancers This trial is for adults with advanced blood cancers. Participants will take KQB198 daily, alone or in combination with another anti-cancer drug, Dasatinib.

5. trial.medpath.com trial.medpath.com/clinical-trial/90777878ef7d5b32/safety-tolerability-kqb198-cancer

A Study to Investigate the Safety and Efficacy of KQB198 as ... The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198.

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/hematologic-neoplasm

UCSF Hematologic Neoplasms Clinical Trials for 2025 ... KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about the safety of KQB198. The main questions it aims ...