ARV-393 for Non-Hodgkin's Lymphoma

Recruiting at 16 trial locations

Overseen By Arvinas Corporation, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Arvinas Inc.

Disqualifiers: Transplant, Infection, Lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that you cannot have had certain treatments like radiotherapy or systemic anticancer treatment shortly before starting the trial. It's best to discuss your current medications with the trial team.

What safety information is available for ARV-393?

There is no specific safety information available for ARV-393 in the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.

Eligibility Criteria

This trial is for individuals with advanced non-Hodgkin's lymphoma that has come back or hasn't responded to treatment. Participants should have specific types of this cancer, like AITL, B-Cell Lymphoma, or T-Cell Lymphoma. Details on who can join are not fully listed here.

Inclusion Criteria

Participants must also have ≥1 measurable lesion at study entry

My B-cell non-Hodgkin lymphoma has not responded to 2 or more treatments, or my AITL has worsened after standard treatment.

My organs are functioning well.

Exclusion Criteria

Participants with an inability to comply with listed prohibited treatments

I haven't had certain cancer treatments recently before starting ARV-393.

I do not have any severe illnesses or infections that would make joining this study unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ARV-393 in a dose escalation format to evaluate safety and tolerability

4 months

Regular visits for dose adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

At least 30 days

Long-term Follow-up

Participants are assessed for overall response rate and duration of response

Approximately 2 years

Treatment Details

Interventions

• ARV-393

Trial Overview The study is testing ARV-393, a new drug given as an oral tablet. It aims to see if it's safe and effective against certain non-Hodgkin's lymphomas by targeting a protein linked to tumor growth.

Participant Groups

Group I: Dose escalation Experimental Treatment 1 Intervention

Dose escalation will begin at Dose Level 1. Dose escalation or de-escalation decision will be recommended by the cohort review committee.

Who Is Running the Clinical Trial?

Arvinas Inc.

Lead Sponsor

Trials

4

Recruited

730+

Findings from Research

Antiretroviral (ARV) medications have been safely used for 20 years in HIV treatment, with an evolving understanding of their potential short-term and long-term side effects.

The safety profile of ARVs is improving with newer combinations and medications, but ongoing monitoring for side effects remains essential, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of antiretroviral drugs. Tymchuk, CN., Currier, JS.[2019]

A pharmacovigilance analysis of 362 reports revealed that ALK-TKIs, particularly crizotinib and alectinib, are associated with cardiac arrhythmias, affecting more men than women with a median age of 68.

The onset of cardiac arrhythmias varies significantly among different ALK-TKIs, indicating that the timing of these adverse effects cannot be easily predicted after starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac arrhythmias associated with anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). Wang, F., Xu, G., Wu, X.[2023]

Adverse drug reactions (ADRs) are common in pediatric patients with oncohematological diseases, with incidence rates ranging from 14.4% to 67% in inpatients and 19.6% to 68.1% during admissions, highlighting the need for careful monitoring in this vulnerable population.

The severity of ADRs can be significant, with 11% to 16.4% classified as severe, yet most studies lacked a thorough assessment of preventability, indicating a gap in safety protocols that could be improved for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review. Amaro-Hosey, K., Danés, I., Agustí, A.[2022]

A total of 921 adverse drug reactions (ADRs) were reported to NAFDAC from January to June 2015, with a higher incidence in females (65.5%) and the age group of 21-40 years (45.6%).

The most common suspected drug associated with ADRs was the Zidovudine/Lamivudine/Nevirapine combination, particularly in patients with HIV, highlighting the need for careful monitoring of patients on antiretroviral therapy due to their increased risk of ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria. Awodele, O., Aliu, R., Ali, I., et al.[2021]

Between 1999 and 2003, a study at Toulouse University Hospital reported 613 adverse drug reactions (ADRs) from antiretroviral drugs affecting 428 patients, highlighting the importance of monitoring these effects.

Most reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required stopping the suspected medication, indicating that while many reactions were mild, a significant portion still necessitated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Bandrant, M., Bagheri, H., Cuzin, L., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

The safety of antiretroviral drugs. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cardiac arrhythmias associated with anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). [2023]

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

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review. [2022]

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

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Not Available]. [2016]