What side effects are associated with this type of intervention?

Common treatments for tumors, especially those targeting specific pathways or receptors like EMB-01, often have side effects such as immune-related adverse events, gastrointestinal issues, skin reactions, and fatigue. Examples include diarrhea, rash, pruritus, pneumonitis, and liver toxicity. Targeted therapies can also cause ocular side effects. Severe adverse events, though less common, can include myocarditis, colitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of tumors. For instance, dabrafenib and trametinib are approved for BRAF V600-mutant melanoma, targeting the BRAF and MEK pathways, respectively. Pembrolizumab, an anti-PD-1 antibody, is approved for various cancers, including non-small cell lung cancer and melanoma, by enhancing the immune system's ability to fight cancer. Cabozantinib, a tyrosine kinase inhibitor, is approved for medullary thyroid cancer, targeting multiple pathways involved in tumor growth. These therapies, like the investigational EMB-01, aim to disrupt specific molecular mechanisms driving cancer progression.

What other types of research exist?

Promising novel alternatives to EMB-01 for tumor patients in 2024 include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various cancers including non-small cell lung cancer (NSCLC) and head and neck cancer. 2) Nivolumab, another PD-1 inhibitor, effective in NSCLC and other solid tumors. 3) Atezolizumab, a PD-L1 inhibitor, used in combination with chemotherapy for NSCLC. 4) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and being explored in other solid tumors. 5) Combination therapies such as nivolumab with ipilimumab (CTLA-4 inhibitor) for enhanced efficacy in certain cancers.

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EMB-01 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called EMB-01 in patients with advanced cancers who have no other treatment options. EMB-01 aims to block two proteins that help cancer cells grow, making it harder for the cancer to survive.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including NSCLC, who've tried standard treatments without success or can't tolerate them. Phase II specifically requires EGFR mutant/cMET aberration and progression after treatment like osimertinib. Participants need good organ function, an ECOG score of 0-1 (or ≤2 for phase II), and must use contraception if fertile.

What is being tested?

EMB-01 is being tested in this first-in-human study to see how it works on various advanced cancers. The trial has two parts: dose escalation to find the safe amount (Phase I) and expansion where more patients get that dose to further assess its effects (Phase II).

What are the potential side effects?

While specific side effects of EMB-01 are not listed here, typical reactions may include fatigue, nausea, skin reactions at injection sites, allergic responses, and potential impacts on liver or kidney functions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have a primary brain tumor or symptoms from brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events (AEs), and Serious Adverse Events (SAEs)

Maximum tolerated dose (MTD) (phase 1 only)

Overall Response Rate (ORR) (phase 2 only)

Secondary study objectives

Accumulation Ratio (AR)

Anti-Drug Antibodies (ADA)

Area Under the Plasma Concentration-Time Curve (AUC)

+8 more

Other study objectives

Pharmacodynamic (Soluble EGFR and cMET concentration)

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: Dose Escalation-Part 1, Expansion-Part 2Experimental Treatment1 Intervention

In part 1, escalating dose cohort, patients will receive intravenous infusions of EMB-01 weekly (QW). The duration of each treatment cycle is 28 days (4 weeks). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached or all planned doses are administered. In part 2, participants will receive intravenous infusion of EMB-01 at the recommended Phase II dose (RP2D) regimen(s) once weekly. The duration of each treatment cycle is 28 days (4 weeks).

0 / 1Eligibility 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

Common treatments for tumors include targeted therapies, immunotherapies, and chemotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically inhibiting molecules involved in tumor growth and survival pathways, thereby reducing tumor proliferation. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against tumor cells by blocking proteins that suppress immune activity. Chemotherapies use cytotoxic agents to kill rapidly dividing cells, including cancer cells. The novel therapeutic agent EMB-01 likely targets specific pathways or receptors crucial for tumor growth, similar to targeted therapies, which can provide a more precise and potentially less toxic treatment option for patients. Understanding these mechanisms is crucial for developing effective treatment strategies and improving patient outcomes.