Soquelitinib for Peripheral T-Cell Lymphoma

Recruiting at 1 trial location

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Corvus Pharmaceuticals, Inc.

Must not be taking: Monoclonal antibodies, Chemotherapy

Disqualifiers: Active CNS lymphoma, HIV, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called soquelitinib for certain types of T-cell lymphoma, a cancer affecting the immune system's T-cells. The trial compares soquelitinib to standard treatments selected by doctors to determine which is more effective for individuals whose cancer has returned or resisted other treatments. Participants will either take soquelitinib pills or receive standard care for up to two years. This trial may suit those with T-cell lymphoma that has been difficult to treat with previous therapies and who are ready to try a new option. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to access a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had monoclonal antibody therapy, radiotherapy, or chemotherapy within 3 weeks, and targeted therapy within 2 weeks before starting the study treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that soquelitinib is generally well-tolerated by patients. Earlier studies found no new safety concerns. Patients did not need to lower their doses or stop treatment due to side effects. This suggests that soquelitinib is safe for people with T-cell lymphomas. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Peripheral T-Cell Lymphoma, which include drugs like pralatrexate and belinostat, Soquelitinib is a new oral medication that targets this condition differently. Soquelitinib is unique because it is taken orally twice a day and may offer a more convenient option compared to other treatments that often require intravenous administration. Researchers are excited about Soquelitinib because it could potentially improve patient outcomes with a new mechanism of action that targets specific pathways within the cancer cells, potentially leading to more effective and tailored treatment options.

What evidence suggests that this trial's treatments could be effective for peripheral T-cell lymphoma?

This trial will compare soquelitinib with standard treatments for peripheral T-cell lymphoma (PTCL). Research has shown that soquelitinib might help treat PTCL by targeting a specific protein in T-cells called ITK. In earlier studies, soquelitinib showed promising results in reducing T-cell exhaustion, potentially enhancing the immune system's ability to fight cancer. Patients treated with soquelitinib demonstrated improved outcomes, suggesting it may benefit those with T-cell lymphomas. Data from these studies offer hope that soquelitinib could be an effective option for treating this type of cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Suresh Mahabhashyam, MD, MPH

Principal Investigator

Corvus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of T-cell lymphoma who have tried up to three treatments that didn't work or they couldn't tolerate. They should be relatively active (able to care for themselves), have a life expectancy over 12 weeks, and their cancer must show on scans.

Inclusion Criteria

My cancer did not respond or stopped responding to 1-3 standard treatments.

My cancer shows up on PET scans and has a tumor at least 1.5 cm big on CT scans.

Life expectancy >12 weeks

Exclusion Criteria

I had cancer that needed treatment throughout my body in the last 3 years.

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study

My T-cell lymphoma affects my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either soquelitinib or physician's choice standard of care treatment for up to 2 years

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Crossover

Participants on standard of care with disease progression may crossover to receive soquelitinib

What Are the Treatments Tested in This Trial?

Interventions

• Soquelitinib

Trial Overview

The study compares Soquelitinib, a new treatment, against the standard drugs chosen by the doctor (Belinostat or Pralatrexate) in patients with specific T-cell lymphomas. It's an open-label Phase 3 trial where participants are randomly assigned to one of two groups.

How Is the Trial Designed?

Group I: Soquelitinib Experimental Treatment 1 Intervention

Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years

Group II: Standard of Care Active Control 2 Interventions

Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06561048

Study Details | NCT06561048 | Soquelitinib vs Standard of ...

This is a Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, ...

2.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/soquelitinib-data-in-t-cell-lymphoma-promising-results-unveiled/

Soquelitinib Data in T-Cell Lymphoma: Promising Results ...

Corvus Pharmaceuticals released additional data from its Phase 1/1b clinical trial of soquelitinib, an oral ITK inhibitor, for T-cell lymphoma (TCL).

3.

corvuspharma.gcs-web.com

corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-presentation-additional-data

Press Release - Corvus Pharmaceuticals

In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow ...

4.

investor.corvuspharma.com

investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-provides-business-update-and-reports-23

Soquelitinib data from cohorts 1-3 of atopic dermatitis ...

Phase 3 registrational clinical trial of soquelitinib in peripheral T cell lymphoma (PTCL) enrolling with multiple clinical sites open.

5.

firstwordpharma.com

firstwordpharma.com/story/6515848

Corvus Pharmaceuticals Provides Business Update and ...

The final data from the Company's Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma will be reported in an oral ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06561048

Study Details | NCT06561048 | Soquelitinib vs Standard of ...

This is a Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, ...

7.

corvuspharma.gcs-web.com

corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-provides-business-update-and-reports-25

Press Release - Corvus Pharmaceuticals

There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug ...

8.

investor.corvuspharma.com

investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo

Press Release

The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 ...

9.

onclive.com

onclive.com/view/fda-grants-fast-track-designation-to-soquelitinib-for-relapsed-refractory-ptcl

FDA Grants Fast Track Designation to Soquelitinib for ...

Previously the agent demonstrated antitumor activity in patients with advanced, refractory T-cell lymphomas in a phase 1/1b trial (NCT03952078).