Q702 for Blood Cancer

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: CYP inhibitors, Herbal supplements

Disqualifiers: Active infections, Cardiac disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new drug, Q702, for treating certain blood cancers. Q702 is designed to help the immune system target and destroy cancer cells while supporting the production of healthy blood cells. The trial seeks participants with specific blood cancers, such as Erdheim-Chester disease or T cell lymphoma, who have not had success with other treatments. For those whose blood cancer hasn't responded to treatment, this trial might be suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, specifically strong inhibitors and inducers of specific enzymes (CYP1A2, CYP2C19, CYP2D6, and CYP3A4) before and during the trial. Herbal supplements should also be discontinued. It's best to discuss your current medications with the trial team to see if they need to be stopped.

Is there any evidence suggesting that Q702 is likely to be safe for humans?

Research has shown that Q702 is generally safe when used alone. Studies have found that patients can tolerate doses up to 240 mg daily without major issues. Although testing remains in the early stages, Q702 has demonstrated potential in fighting cancer cells. It is important to note that this trial is in its first phase, focusing on identifying the safest dose. This means the treatment's safety is still under investigation, and more side effects could emerge as more people use the drug. However, early results are promising regarding patient tolerance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for blood cancer, which often include chemotherapy and targeted therapies, Q702 offers a novel approach by being administered orally and following a unique dosing schedule. Researchers are excited about Q702 because it targets cancer cells in a new way, potentially offering fewer side effects and more convenience for patients. This treatment's innovative mechanism of action could provide an alternative for those who do not respond well to existing therapies, making it a promising option in the fight against blood cancer.

What evidence suggests that Q702 might be an effective treatment for blood cancer?

Research shows that Q702, the treatment being tested in this trial, holds promise for treating blood cancers. Early lab studies demonstrated that Q702 can kill cancer cells and shrink tumors. It boosts the immune system's ability to fight cancer while aiding in the production of healthy blood cells. Initial results suggest that Q702 might improve treatment outcomes by targeting both cancer and immune cells. Although information from human studies remains limited, these encouraging results offer hope for its effectiveness in treating blood cancers. ^{1 2 3 5 6}

Who Is on the Research Team?

Jithma P. Abeykoon, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with various blood-related cancers like lymphoma and leukemia. Participants should have a type of cancer that hasn't responded to standard treatments or has come back. They'll undergo tests like bone marrow biopsies, CT scans, MRIs, and PET scans to monitor their response.

Inclusion Criteria

I am willing to give samples of my blood, bone marrow, saliva, and tissue for research.

Ability to swallow pills

Specific laboratory values within defined ranges

Exclusion Criteria

I am not taking any herbal supplements.

I have an active eye disorder, but it might be an exception.

I do not have an active infection with any specific viruses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Q702 orally on days 1-7 and 15-21 of each 28-day cycle. After 6 cycles, patients may continue for an additional 6 cycles if they have not progressed.

6-12 months

Regular visits for blood and urine sample collection, imaging, and bone marrow biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 6 months and at disease progression for 2 years.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Q702

Trial Overview The trial is testing Q702's safety and the best dose to use. Q702 is an immunomodulatory agent—it boosts the immune system to fight cancer cells and helps produce healthy blood cells in the bone marrow.

How Is the Trial Designed?

Group I: Treatment (Q702) Experimental Treatment 8 Interventions

Patients receive Q702 PO QD on days 1-7 and 15-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients who have not progressed/relapsed may continue on therapy at their current dose at MD/patient discretion for an additional 6 cycles. Patients undergo blood and urine sample collection and may undergo PET scan/CT scan or MRI and bone marrow aspiration and biopsy throughout the study.

Q702 is already approved in United States for the following indications:

Approved in United States as Q702 for:

• None approved; under investigation for various cancers including acute myeloid leukemia (AML), esophageal, gastric/GEJ, hepatocellular, and cervical cancers

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Cabozantinib has been shown to significantly improve overall survival and progression-free survival in patients with advanced renal cell carcinoma compared to everolimus, as demonstrated in the METEOR trial.

While cabozantinib is effective, it is associated with several adverse events such as diarrhea, fatigue, and hypertension, which need to be managed carefully to ensure patient adherence and optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Adverse Events Associated with Cabozantinib Therapy in Renal Cell Carcinoma. Schmidinger, M., Danesi, R.[2022]

A review of 35 new drugs for hematological malignancies revealed that 80% had postmarketing safety-related label modifications, indicating that many drugs may have unrecognized side effects after approval.

Most of these drugs were approved based on limited evidence, with 77% not supported by randomized controlled trials, highlighting the need for caution among hematologists when prescribing these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. Gafter-Gvili, A., Tibau, A., Raanani, P., et al.[2020]

Crizotinib, an ALK inhibitor, has been established as a new standard of care for advanced ALK-positive non-small cell lung cancer (NSCLC) due to its significant efficacy and favorable safety profile observed in phase I, II, and III trials.

Most adverse events associated with crizotinib are mild to moderate, and with proper monitoring and supportive care, dose interruptions can often be avoided, allowing patients to continue benefiting from the treatment even after initial disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. Cappuzzo, F., Moro-Sibilot, D., Gautschi, O., et al.[2018]

Gö6976 effectively inhibits the proliferation of chronic myeloid leukemia (CML) cells in vitro and shows significant anti-CML effects in vivo at a dosage of 2.5 mg/kg in mice.

The drug demonstrates minimal toxicity to normal cells, including CD34+ cells and peripheral blood mononuclear cells, suggesting it could be a promising new treatment for CML with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Gö6976 on chronic myeloid leukemia in vitro and in vivo. Cao, ZR., Chen, XP., Feng, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06712810

Q702 for the Treatment of Patients With Hematologic ... Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies. SECONDARY OBJECTIVES:

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT072/761597/Abstract-CT072-First-in-human-trial-of-Q702-in

Abstract CT072: First in human trial of Q702 in patients with ... This is a first-in-human, multicenter, dose escalation and expansion study of Q702 in patients with advanced solid tumors (NCT04648254).

3. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/5994/527611/Phase-1-Study-of-AXL-MER-CSF1R-Inhibitor-Q702-with

Phase 1 Study of AXL/MER/CSF1R Inhibitor Q702 with ... Complete remission (CR) rates with the best salvage therapy regimens range from 3 to 14% with median overall survival (OS) of 3 to 6 months.

4. qurient.com qurient.com/bbs/content.php?co_id=q702

Q702 : Axl/Mer/CSF1R Triple Inhibitor Preclinical data show that Q702 induces dose-dependent cytotoxicity, triggers apoptosis, and significantly inhibits tumor growth. These promising findings have ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9563311/

A Novel Selective Axl/Mer/CSF1R Kinase Inhibitor as ... Our data indicate that therapy targeting both immune cells and cancer cells in the TME by Q702 can induce more effective clinical responses in patients with ...

6. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A742

651 A phase 1, multicenter, open-label, dose-escalation, ... Conclusions Q702 is a novel Axl/Mer/CSF1R inhibitor with a manageable monotherapy safety profile up to 240 mg daily and early signals of anti- ...