EVOLVE104 for Bladder and Lung Cancer

Recruiting at 1 trial location

Overseen By Evolve Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: EvolveImmune United, Inc

Disqualifiers: Cardiac disease, Brain metastases, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called EVOLVE104 for individuals with advanced bladder or lung cancer. The primary goal is to assess the safety and effectiveness of this treatment for those who have not succeeded with standard treatments or could not tolerate them. Participants should have a cancer type visible on a CT or MRI scan that may still be progressing despite previous treatments. Ideal candidates are those with advanced or metastatic cancer that has continued to progress after other 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 it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that EVOLVE104 is likely to be safe for humans?

Research has shown that EVOLVE104, a new treatment being tested, holds promise in early studies for people with certain advanced cancers. This treatment enhances the immune system's T cells to fight cancer. Before human testing, studies demonstrated that EVOLVE104 was safe and effective in models of bladder, lung, and other cancers.

The current trial is in an early phase, focusing primarily on understanding the safety of EVOLVE104 in humans. This phase is crucial for determining how well people tolerate the treatment and identifying potential side effects. Early-phase trials like this typically involve a small number of participants to closely monitor any unwanted effects and adjust doses as needed.

While specific results from this trial are not yet available, the study's progression suggests that earlier research supported its potential safety. Prospective participants should discuss the possible risks and benefits with the study team to understand what participation might entail. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about EVOLVE104 because it offers a new approach to treating bladder and lung cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, EVOLVE104 is designed to specifically target cancer cells, potentially reducing side effects. This targeted mechanism could mean more effective treatment with less impact on healthy cells. Additionally, if EVOLVE104 can demonstrate quicker or more durable responses in patients, it might change how these cancers are managed, bringing much-needed innovation to current treatment options.

What evidence suggests that EVOLVE104 might be an effective treatment for bladder and lung cancer?

Research has shown that EVOLVE104, administered to participants in this trial at various dose levels, could help treat certain cancers by targeting a specific protein in tumor cells. This protein, ULBP2/5/6, is present in squamous tumors, a type of cancer cell. Studies have found that EVOLVE104 acts as a bridge, enabling the body's immune cells to attack these tumors more effectively. In lab tests, it demonstrated strong results against these cancer cells. This method represents a new way to harness the immune system to fight cancer, offering hope for those with limited treatment options. ^{1 2 5 6 7}

Who Is on the Research Team?

EvolveImmune Study Team

Principal Investigator

EvolveImmune United, Inc

Are You a Good Fit for This Trial?

This trial is for adults with advanced urothelial and squamous cell carcinomas, including cancers of the esophagus, anus, bladder, tongue, vulva, lung, skin, penis, and cervix. Participants should have tried standard treatments without success or be ineligible for them.

Inclusion Criteria

The cancer must be measurable by CT scan or MRI

Anticipated life expectancy of at least 3 months

I can carry out all my self-care but cannot work.

Exclusion Criteria

Prior severe or life-threatening immunologic reactions to previous therapies

I am eligible for treatment with a drug known to help my condition.

I still have major side effects from previous cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose-Escalation

Participants receive escalating doses of EVOLVE104 to determine the maximum tolerated dose

10 months

Routine visits for safety and efficacy assessments

Phase 1b Dose Expansion

Participants receive the recommended dose for expansion to further evaluate safety and efficacy

10 months

Routine visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EVOLVE104

Trial Overview The study tests EVOLVE104's safety and effectiveness in patients with certain advanced cancers. It aims to see how well this drug works after other treatments have failed or if patients couldn't receive those treatments.

How Is the Trial Designed?

Group I: Phase 1b Cohort 2; dose level TBD Experimental Treatment 1 Intervention

Active study drug

Group II: Phase 1b Cohort 1; dose level TBD Experimental Treatment 1 Intervention

Active study drug

Group III: Phase 1a Cohort 9; dose level 9 Experimental Treatment 1 Intervention

Active Study Drug

Group IV: Phase 1a Cohort 8; dose level 8 Experimental Treatment 1 Intervention

Active Study Drug

Group V: Phase 1a Cohort 7; dose level 7 Experimental Treatment 1 Intervention

Active Study Drug

Group VI: Phase 1a Cohort 6; dose level 6 Experimental Treatment 1 Intervention

Active Study Drug

Group VII: Phase 1a Cohort 5; dose level 5 Experimental Treatment 1 Intervention

Active Study Drug

Group VIII: Phase 1a Cohort 4; dose level 4 Experimental Treatment 1 Intervention

Active Study Drug

Group IX: Phase 1a Cohort 3; dose level 3 Experimental Treatment 1 Intervention

Active Study Drug

Group X: Phase 1a Cohort 2; dose level 2 Experimental Treatment 1 Intervention

Active Study Drug

Group XI: Phase 1a Cohort 1; dose level 1 Experimental Treatment 1 Intervention

Active Study Drug

Group XII: Phase 1a Cohort 10; dose level 10 Experimental Treatment 1 Intervention

Active Study Drug

Who Is Running the Clinical Trial?

EvolveImmune United, Inc

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217171

NCT07217171 | A Study Evaluating the Safety, Efficacy, ... The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell ...

2. evolveimmune.com evolveimmune.com/wp-content/uploads/SITC2024_EV104Poster_PatientSelection_3_3.pdf

Precision oncology strategy for EVOLVE104, a ... Transformative Outcomes. Precision oncology strategy for EVOLVE104, a differentiated T cell engager for the novel solid tumor target ULBP2/5/6.

3. trialx.com trialx.com/clinical-trials/listings/325221/a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas/

A Study Evaluating the Safety, Efficacy, ... Overview. The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=9609ff0e-74a0-49de-b8df-84c2bbcf1136

EVOLVE-104 / EvolveImmune Therap EVOLVE104, a differentiated T cell engager targeting the novel antigen ULBP2/5/6, exhibits potent preclinical efficacy for the treatment of squamous tumors ...

5. evolveimmune.com evolveimmune.com/wp-content/uploads/20231016-EV104_SITC-Poster_final_5.pdf

EVOLVE-104, a novel ULBP2-targeted T cell engager that ... EVOLVE-104, a novel ULBP2-targeted T cell engager that integrates CD2 costimulation for the treatment of basal and squamous lineage tumors.

6. evolveimmune.com evolveimmune.com/wp-content/uploads/ACCR_2025_EV104Poster.pdf

EVOLVE104 is a differentiated T cell engager targeting the ... EVOLVE104 has integrated CD2 costimulation to enhanced sustained T cell effector function and decrease T cell exhaustion in the tumor microenvironment.

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3519/758940/Abstract-3519-EVOLVE104-a-differentiated-T-cell

Abstract 3519: EVOLVE104, a differentiated T cell engager ... EVOLVE104 is the first CD3 T cell engager (TCE) being developed for solid tumors which utilizes integrated CD2 T cell co-stimulation.