107 Participants NeededMy employer runs this trial

GI-102 + Pasritamig for Prostate Cancer

Recruiting at 5 trial locations
KS
Overseen ByKwang-Soo Shin
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: GI Innovation, Inc.
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for men with prostate cancer that has spread and isn't responding to standard hormone therapies. The goal is to determine if the drugs GI-102 (an experimental treatment) and pasritamig are safe and effective against cancer. The trial includes different groups to assess the optimal frequency of treatment administration. Men with prostate cancer that hasn't improved with previous hormone treatments and who have noticeable disease symptoms might be suitable candidates. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from a potentially groundbreaking therapy.

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

Research has shown that GI-102 has been tested in cancer patients, with fever and chills as the most common side effects, affecting about 44% of patients. Other studies have examined GI-102 for its safety and potential to help the immune system fight cancer.

Specific safety information for pasritamig is not yet available. However, this trial is in an early stage, so researchers are closely monitoring safety and side effects.

Overall, studies suggest that GI-102 is generally well-tolerated, though some people may experience mild to moderate side effects like fever and chills. The safety of pasritamig will become clearer as the trial progresses. It is important to discuss any concerns with a doctor before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of GI-102 and pasritamig for prostate cancer treatment because it offers a novel approach by targeting the immune system. Unlike traditional hormone therapies or chemotherapy, GI-102 is a fusion protein combining CD80 and IL2, which may enhance the body's immune response against cancer cells. Additionally, pasritamig’s role as a potential immune modulator could complement GI-102, possibly leading to more effective tumor suppression. This unique mechanism of action sets it apart from current treatments and holds promise for improved outcomes in managing prostate cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that GI-102 helps the immune system fight cancer. Early studies have found it active in prostate cancer patients, suggesting potential effectiveness for other cancer types. Pasritamig, another treatment, has shown promising results against tumors, especially when combined with docetaxel in advanced prostate cancer. Past studies demonstrated that pasritamig significantly lowered prostate-specific antigen (PSA) levels, indicating it might slow cancer growth. This trial tests these treatments together in various dosing schedules to determine if they can better manage prostate cancer that has spread and hasn't responded to other treatments.678910

Are You a Good Fit for This Trial?

This trial is for adult men with metastatic castration-resistant prostate cancer whose cancer has gotten worse after trying newer hormone therapies. Participants should be in generally stable health and able to follow study procedures.

Inclusion Criteria

PSA ≥2 ng/mL at screening
Willingness and ability to comply with study procedures and protocol-specified contraception requirements
My organs, bone marrow, and heart are working well.
See 7 more

Exclusion Criteria

I have or had serious lung inflammation or interstitial lung disease.
I do not have any serious uncontrolled health conditions affecting major organs.
I do not have allergies to GI-102, pasritamig, or their ingredients.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety run-in

Participants receive GI-102 every 3 or 6 weeks in combination with pasritamig. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.

5 weeks
Visits every 3 or 6 weeks

Expansion

Participants receive the combination recommended Phase 2 regimen (cRP2R) of GI-102 and pasritamig, determined based on the safety and dose-escalation results from the Safety run-in phase.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GI-102 (CD80-IgG4 Fc-IL2v3)
  • Pasritamig

Trial Overview

The study is testing a new drug called GI-102 given together with another drug, pasritamig, to see if this combination is safe and can help treat advanced prostate cancer that no longer responds to standard hormone treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Safety run-in: GI-102 Q6W + pasritamigExperimental Treatment2 Interventions
Group II: Safety run-in: GI-102 Q3W + pasritamigExperimental Treatment2 Interventions
Group III: ExpansionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GI Innovation, Inc.

Lead Sponsor

Trials
2
Recruited
790+

Janssen Research & Development, LLC

Industry Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

Are there clinical trials for ERG protein research in prostate ...

The study found that ERG works by transforming one type of prostate cell (basal cells) into the cancer cells that make up most tumors (luminal ...

GI Innovation Announces First Clinical Supply Agreement ...

This trial aims to evaluate the combination of GI Innovation's immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class ...

GI Innovation Announces First Clinical Supply Agreement ...

This trial aims to evaluate the combination of GI Innovation's immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class ...

Initial Clinical Study Shows Safety and Bioactivity of ...

"And while this work was done in prostate cancer patients, we believe this method may prove to work in most cancers, not just prostate cancer.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27768220/

GNRH-agonist or antagonist in the treatment of prostate ...

GNRH-agonist or antagonist in the treatment of prostate cancer: a comparision based on oncological results. Urologia. 2016 Nov 18;83(4):173 ...

GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With ...

The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination ...

Efdelikofusp alfa - Drug Targets, Indications, Patents

Evaluate the Anti-cancer Activity, Safety and Tolerability of GI-102 (CD80-IgG4 Fc-IL2v3) Prostate Cancer (mCRPC)

An open-label, multicenter, dose escalation and expansion ...

An open-label, multicenter, 1/2 study to evaluatethe safety, tolerability and pharmacokinetics, and anti-tumor activity of GI-102, a CD80-IgG4Fc-IL-2v ...

A first-in-human, phase 1/2a study of GI-102 (CD80-IL2v3 ...

Here we report preliminary safety and efficacy data of GI-102. The most common treatment-related adverse events (TRAEs, ≥ 10%) were pyrexia [43.8%] and chills ...

GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With ...

The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with ...