What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infection, and low blood cell counts. Immunotherapy, including drugs like rituximab, may lead to infusion reactions, fever, chills, fatigue, and infections. Targeted therapies, such as those involving monoclonal antibodies or kinase inhibitors, can result in side effects like diarrhea, liver problems, high blood pressure, and skin rashes. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL), including monoclonal antibodies and combination therapies. Rituximab, an anti-CD20 monoclonal antibody, is commonly used either alone or in combination with chemotherapy agents like bendamustine. Other approved monoclonal antibodies include ofatumumab and obinutuzumab. These treatments are similar to the investigational drug PRO1160, which is being studied for its therapeutic effects on metastatic or unresectable solid tumors and liquid cancers, including NHL.

What other types of research exist?

Promising novel alternatives to PRO1160 for Non-Hodgkin's Lymphoma patients in 2024 include: 1) Venetoclax plus obinutuzumab, which has shown improved progression-free survival and acceptable tolerability. 2) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated high response rates in relapsed or refractory NHL. 3) Bispecific antibodies like mosunetuzumab, which target CD20 and CD3, offering a novel mechanism of action. 4) Lenalidomide in combination with rituximab, which has shown efficacy in various subtypes of NHL. These therapies represent significant advancements in the treatment landscape for NHL.

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PRO1160 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by ProfoundBio US Co.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 or 1

Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma

Must not have

Other malignancy within 3 years

Prior treatment with anti-CD70 directed therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of treatment, up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests PRO1160, a targeted cancer treatment, in patients with advanced or hard-to-remove cancers. PRO1160 uses an antibody to find cancer cells and a drug to kill them.

Who is the study for?

This trial is for adults with advanced cancers like kidney cancer, nasopharyngeal cancer, or stage III/IV non-Hodgkin's lymphoma that have worsened after treatment. Participants must be able to provide a tumor sample and should not have had certain other cancers in the last 3 years or been treated with anti-CD70 therapy.

What is being tested?

PRO1160 is being tested on participants with solid tumors or liquid cancers that are metastatic or unresectable. The study has two parts: Part A determines the best dose and schedule of PRO1160; Part B assesses its safety and effectiveness at the determined dose against specific types of cancer.

What are the potential side effects?

While detailed side effects are not listed, as this is an early-phase trial for PRO1160, potential side effects typically include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced and cannot be surgically removed.

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My condition worsened or didn't improve after treatment known to help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer in the last 3 years.

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I have been treated with anti-CD70 therapy before.

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I am positive for HBV, HCV, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of treatment, up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of treatment, up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of treatment, up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Disease Control Rate

Duration of objective response

Objective Response Rate

+2 more

Other study objectives

Immunogenic potential of PRO1160

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRO1160Experimental Treatment1 Intervention

PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system. Targeted therapies, like kinase inhibitors, interfere with specific molecules involved in cancer cell growth and survival. Understanding these mechanisms is crucial for NHL patients as it helps in selecting the most effective treatment with manageable side effects, and it aligns with ongoing research like the PRO1160 trial, which aims to refine and improve therapeutic strategies for advanced cancers.