PRO1160 for Advanced Cancer

No longer recruiting at 34 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Other malignancy, Active CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PRO1160, to determine its safety and effectiveness for people with certain advanced cancers. It targets cancers that have spread or cannot be surgically removed, specifically kidney cancer, virus-linked nose and throat cancer, and certain blood cancers. It suits those whose cancer has returned or not responded to previous treatments. As a Phase 1 trial, this research aims to understand 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 does not specify if you need to stop taking your current medications, but you cannot use a strong P450 CYP3A inhibitor within 14 days before starting the trial.

Is there any evidence suggesting that GEN1160 is likely to be safe for humans?

Research shows that PRO1160, also known as GEN1160, is under study for safety in individuals with advanced solid tumors and blood cancers. Earlier studies found that participants generally tolerated PRO1160 well. Reported side effects included tiredness, nausea, and low blood cell counts, but these were manageable. PRO1160 is currently in an early-stage study, so safety information is still being collected. Its progression through these stages suggests that early findings indicate it is safe enough for continued study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy and targeted therapies, PRO1160 is unique because it focuses on a novel mechanism of action. PRO1160 acts as a monotherapy with the potential to precisely target cancer cells, minimizing damage to healthy cells. Researchers are excited because this approach could lead to fewer side effects and potentially more effective outcomes for patients with advanced cancer. By optimizing the dose through careful escalation, PRO1160 aims to maximize its therapeutic impact while maintaining safety.

What evidence suggests that PRO1160 might be an effective treatment for advanced cancer?

Research has shown that GEN1160, also known as PRO1160, could help treat advanced cancers. This drug is a targeted treatment, using a special protein to locate and attack cancer cells directly. Early results suggest this method might work well for cancers that are difficult to remove with surgery or have recurred after treatment. This trial tests PRO1160 specifically for its potential to treat Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Non-Hodgkin Lymphoma, and diffuse large B-cell lymphoma. While initial findings are promising, ongoing research is needed to confirm its effectiveness and safety for these cancer types. ^{1 5 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer is advanced and cannot be surgically removed.

You are willing to give a sample of your tumor, either from a previous biopsy or a new one.

Exclusion Criteria

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

I haven't had a severe infection in the last 2 weeks.

I have been treated with anti-CD70 therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Evaluation of up to 7 dose levels of PRO1160 on Day 1 of a 21-day cycle by IV infusion

21 days per cycle, multiple cycles

Dose Expansion (Part B)

Initiation at a dose level based on analysis from Part A in up to 4 different cohorts

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• PRO1160

Trial Overview 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.

How Is the Trial Designed?

Group I: GEN1160 Experimental Treatment 1 Intervention

GEN1160 monotherapy in escalating doses in the dose escalation part and at the recommended phase 2 dose in the expansion parts.

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

ProfoundBio US Co.

Lead Sponsor

Trials

3

Recruited

750+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05721222

NCT05721222 | Trial of PRO1160 (GEN1160) in Relapsed ... This study will test the safety, including side effects, and determine the characteristics of a drug called GEN1160 (PRO1160) in participants with solid tumors ...

2. tipranks.com tipranks.com/news/company-announcements/genmabs-gen1160-study-a-potential-game-changer-in-cancer-treatment

Genmab's GEN1160 Study: A Potential Game-Changer in ... This drug is being explored for its potential to treat solid tumors and blood cancers that are metastatic, unresectable, or have relapsed after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10445573/

Phase 1/2 study of PRO1160, a CD70-directed antibody- ... Phase 1/2 study of PRO1160, a CD70-directed antibody-drug conjugate, in patients with advanced solid tumors and hematologic malignancies · Eric Jonasch, MD.

4. withpower.com withpower.com/trial/phase-2-lymphoma-2-2023-a2989

PRO1160 for Advanced Cancer 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 ...

5. kidneycancer.org kidneycancer.org/trial/pro1160-for-advanced-solid-and-liquid-tumors-pro1160-001/

PRO1160 for Advanced Solid and Liquid Tumors ... This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors.

6. academic.oup.com academic.oup.com/oncolo/article/28/Supplement_1/S14/7246380

Phase 1/2 study of PRO1160, a CD70-directed antibody-drug ... PRO1160-001 is an ongoing, open-label Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=34b35742-f935-4789-8363-8a2c0c964d75

GEN1160 / Genmab Phase 1/2 study of PRO1160, a CD70-directed antibody-drug conjugate, in patients with advanced solid tumors and hematologic malignancies.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05721222/trial-of-pro1160-gen1160-in-relapsed-or-refractory-non-hodgkin-lymphoma-nhl-pro1160-001?page=16&state=NC&city=Charlotte

Trial of PRO1160 (GEN1160) in Relapsed or Refractory ... This study will test the safety, including side effects, and determine the characteristics of a drug called GEN1160 (PRO1160) in participants ...