What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that involve immune modulation or direct cytotoxicity, similar to TAK-186 (MVC-101), include chemotherapy agents like cisplatin, paclitaxel, and gemcitabine, as well as targeted therapies such as trastuzumab-deruxtecan and immune checkpoint inhibitors like nivolumab. These treatments often have side effects such as fatigue, nausea, neuropathy, and hematologic toxicities (e.g., neutropenia, anemia). Immune checkpoint inhibitors can also cause immune-related adverse events, including pneumonitis, colitis, and dermatitis.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) involve immune modulation or direct cytotoxicity. Nivolumab, an immunoglobulin G4 (IgG4) monoclonal antagonist antibody to programmed cell death protein 1 (PD-1), is approved for use in patients with progression after chemotherapy. Pembrolizumab, another PD-1 inhibitor, is approved for tumors expressing PD-L1. Additionally, the MET inhibitor capmatinib is approved for NSCLC with MET exon-14-skipping mutations. These treatments, like TAK-186 (MVC-101), aim to target cancer cells through immune modulation or direct cytotoxic effects.

What other types of research exist?

Promising novel alternatives to TAK-186 (MVC-101) for NSCLC patients include TAC-101 and W941. TAC-101 has shown significant life-prolonging effects in lung cancer models, particularly in experimental liver metastasis. W941, a PI3K inhibitor, has demonstrated preferable anti-proliferative activities against NSCLC in xenograft models, inhibiting key proteins in the PI3K pathway and inducing autophagy.

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TAK-186 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Maverick Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Tumor Histology Types: Dose escalation will begin by initially enrolling participants with histologically proven, unresectable, locally advanced or metastatic solid tumors that based on prior literature reports are considered to express epidermal growth factor receptor (EGFR).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 13 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TAK-186 to see if it is safe and effective for adults with advanced cancers that cannot be removed by surgery. The drug works by targeting a specific protein on cancer cells to help stop their growth.

Who is the study for?

Adults with advanced or metastatic cancer that can't be removed, who have a life expectancy of at least 12 weeks and measurable disease. They must be in relatively good health (ECOG ≤1), have acceptable blood test results, and provide informed consent. Specific types of cancers like NSCLC, HNSCC, and CRC are included if they've progressed after standard treatments.

What is being tested?

The trial is testing TAK-186 (MVC-101) for safety and effectiveness in treating various advanced cancers. Participants will receive the treatment for up to 13 months with follow-ups at specified intervals to monitor their response.

What are the potential side effects?

While specific side effects of TAK-186 (MVC-101) aren't listed here, common side effects from cancer treatments may include fatigue, nausea, inflammation at the injection site, allergic reactions, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My tumor is advanced or metastatic and likely has EGFR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 13 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

Number of Participants with Cytokine Release Syndrome/Infusion Reactions

Therapeutic procedure

Secondary study objectives

Duration of Response

Objective Response Rate (ORR)

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation PhaseExperimental Treatment1 Intervention

TAK-186 initial 60 minutes infusion and 30 minutes subsequent infusions on Day 1 of every week in Dose Escalation Phase. Participants may receive additional treatment with TAK-186. Dose escalation will be carried out in sequential cohorts of escalating doses.

Group II: Cohort Expansion Phase: NSCLCExperimental Treatment1 Intervention

Participants with non-small cell lung cancer (NSCLC) will be randomized to receive low dose or high dose of RDE of TAK-186 infusion on Day 1 of every week during Dose Expansion Phase of the study. Participants may receive additional treatment with TAK-186. Based on the results for this cohort additional cohorts for HNSCC and CRC, may be enrolled.

0 / 2Eligibility 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 Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), work by blocking specific molecules involved in cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors (e.g., pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells. Traditional chemotherapies, such as platinum-based drugs, kill rapidly dividing cells, including cancer cells. TAK-186 (MVC-101) is likely a novel agent that may combine immune modulation and direct cytotoxicity to target cancer cells. Understanding these mechanisms is crucial for NSCLC patients as it helps in selecting the most appropriate treatment based on the cancer's specific characteristics and the patient's overall health.