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

Trial Summary

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 Q702 safe for humans?

Drugs for blood cancers, like Q702, are often approved quickly with limited safety data, and many have safety updates after approval. It's important to be cautious and discuss potential side effects with your doctor. ^{1 2 3 4 5}

How is the drug Q702 different from other blood cancer treatments?

Q702 is unique because it targets specific pathways involved in blood cancer cell growth and survival, potentially offering a new approach compared to existing treatments that may not address these pathways. ^{6 7 8 9 10}

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies.

Research Team

Jithma P. Abeykoon, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

Specific laboratory values within defined ranges

Ability to swallow pills

Ability to complete questionnaire(s) by themselves or with assistance

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an Attenuated-Dose Sunitinib Regimen in Metastatic Renal Cell Carcinoma: Results From a Prospective Registry in Singapore. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Management of Adverse Events Associated with Cabozantinib Therapy in Renal Cell Carcinoma. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Fatigue with vascular endothelial growth factor receptor tyrosine kinase inhibitors and mammalian target of rapamycin inhibitors in patients with renal cell carcinoma (RCC) and other malignancies: A meta-analysis of randomized clinical trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The effect of Gö6976 on chronic myeloid leukemia in vitro and in vivo. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Influence of Qingdai compound on expression of bcr/abl and JWA in K562 cells]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Sensitive Replicate Real-Time Quantitative PCR of BCR-ABL Shows Deep Molecular Responses in Long-Term Post-Allogeneic Stem Cell Transplantation Chronic Myeloid Leukemia Patients. [2015]

9. Ireland pubmed.ncbi.nlm.nih.gov

Novel indoloquinoline derivative, IQDMA, suppresses STAT5 phosphorylation and induces apoptosis in HL-60 cells. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Tyrosine kinase inhibitor-induced CD70 expression mediates drug resistance in leukemia stem cells by activating Wnt signaling. [2017]