EU101 for Solid Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Eutilex

Must not be taking: Anti-CD137, Corticosteroids

Disqualifiers: CNS tumor, Active infection, HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

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 be on systemic corticosteroids or other immunosuppressive medications one week before starting the trial.

What data supports the effectiveness of the drug EU101 for solid cancers?

The research shows that drugs targeting the epidermal growth factor receptor (EGFR), like necitumumab, have improved survival in lung cancer patients when combined with other treatments. This suggests that targeting EGFR, which may be a component of EU101, could be effective in treating solid cancers.

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Eligibility Criteria

This trial is for adults with advanced solid tumors, including colorectal and non-small cell lung cancer, where standard treatments have failed or aren't suitable. Participants must be in relatively stable health with a life expectancy of at least 12 weeks and have adequate organ function. Women who can bear children and sexually active men must use effective contraception.

Inclusion Criteria

Voluntarily provided a written consent to participate in the study

My blood tests show normal organ function and I don't have anemia or infections.

I agree to use two effective birth control methods during and for 12 weeks after the study.

Exclusion Criteria

I have previously been treated with an anti-CD137 agent.

My doctor thinks I shouldn't join the study.

I have had noninfectious hepatitis in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants receive EU101 intravenously once every 3 weeks with escalating doses to determine the maximum tolerated dose and recommended Phase 2 dose

Approximately 24 months

Every 3 weeks (in-person)

Phase 2: Dose Expansion

Participants with CRC and NSCLC receive EU101 intravenously once every 3 weeks at the recommended Phase 2 dose to assess antitumor effect

Approximately 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study is testing EU101's safety and dosage limits in Phase 1, then its effectiveness against specific cancers in Phase 2. It involves gradually increasing doses to find the highest dose that doesn't cause unacceptable side effects (MTD) and deciding on the best dose for further studies (RP2D).

Group I: EU101: Dose Expansion Cohort 2 Experimental Treatment 1 Intervention

Participants with NSCLC will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with a determined recommended phase 2 dose until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.

Group II: EU101: Dose Expansion Cohort 1 Experimental Treatment 1 Intervention

Participants with CRC will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with a determined recommended phase 2 dose until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.

Group III: EU101: Dose Escalation Cohort Experimental Treatment 1 Intervention

Participants with advanced solid tumors will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with escalating doses starting from 0.05 milligrams per kilogram (mg/kg) to 10 mg/kg until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.

EU101 is already approved in United States, China for the following indications:

🇺🇸 Approved in United States as EU101 for:

• Advanced solid tumors
• Colorectal cancer (CRC)
• Non-small cell lung cancer (NSCLC)

🇨🇳 Approved in China as Eutilex for:

• Advanced solid tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mary Crowley Center Dallas, TX

Fox Chase Cancer Center Philadelphia, PA

Who Is Running the Clinical Trial?

Eutilex Lead Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Necitumumab plus Gemcitabine and Cisplatin as First-Line Therapy in Patients with Stage IV EGFR- Expressing Squamous Non-Small-Cell Lung Cancer: German Subgroup Data from an Open-Label, Randomized Controlled Phase 3 Study (SQUIRE). [2022] In the SQUIRE study, adding the anti-epidermal growth factor receptor (EGFR) IgG1 antibody necitumumab to first-line gemcitabine and cisplatin (GC + N) in advanced squamous non-small-cell lung cancer (sqNSCLC) significantly improved overall survival (OS); the safety profile was acceptable. We explored data for the German subpopulation (N = 96) of SQUIRE patients with EGFR-expressing tumors.

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

A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study. [2022] This randomised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer.

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

Synergistic antitumor effects of combined epidermal growth factor receptor and vascular endothelial growth factor receptor-2 targeted therapy. [2018] Combination therapies that target the epidermal growth factor receptor (EGFR) and vascular endothelial growth factor receptor (VEGFR) pathways, are being actively tested for the treatment of cancer. In evaluating combination strategies, the ideal combination would be one in which the treatments interact in a way that is synergistic with regard to antitumor effects. Here, we have evaluated the interaction between anti-EGFR antibody Erbitux (cetuximab) and anti-VEGFR2 antibody, DC101, in preclinical models of pancreatic (BxPC-3) and colon (GEO) cancer.

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

Matuzumab short-term therapy in experimental pancreatic cancer: prolonged antitumor activity in combination with gemcitabine. [2022] The epidermal growth factor receptor ErbB-1 is commonly expressed in pancreatic cancer and ErbB-1 targeting has shown promising results. We wanted to evaluate matuzumab (EMD72000), a fully humanized ErbB-1-specific monoclonal antibody in combination with gemcitabine in experimental pancreatic cancer.

5. England pubmed.ncbi.nlm.nih.gov

Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. [2022] SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression.