40 Participants Needed

DPTX3186 for Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Dewpoint Therapeutics
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 called DPTX3186 for solid tumors with changes in the Wnt pathway, a group of genes linked to cancer growth. It targets individuals who have tried other treatments without success, specifically for cancers like colorectal, gastric, lung, and triple-negative breast cancer. The trial aims to assess the safety of DPTX3186, how the body processes it, and any potential benefits for cancer. Individuals with these cancers and no other treatment options might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how DPTX3186 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that DPTX3186 is likely to be safe for humans?

Research shows that DPTX3186 is under investigation for its potential to treat certain cancers. The FDA has granted DPTX3186 special designations, Fast Track and Orphan Drug, for gastric cancer, indicating its promise as a treatment. Although this is an early study, these designations suggest potential benefits and a safety profile worth further exploration.

Since this is the first human trial of DPTX3186, information on its tolerance is limited. However, the FDA's recognition of the drug's potential is a positive sign. As the trial progresses, more safety information will emerge, clarifying any side effects. Currently, DPTX3186’s safety in humans remains under study, but its progress is encouraging.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often include chemotherapy and radiation, DPTX3186 is unique because it targets cancer cells with a novel mechanism of action. Most traditional treatments attack rapidly dividing cells indiscriminately, but DPTX3186 is designed to specifically target and disrupt cancer cell growth at the molecular level, potentially reducing harm to healthy cells. Researchers are excited about this treatment because it could offer a more precise and less toxic alternative to current options, improving patient outcomes and quality of life.

What evidence suggests that DPTX3186 might be an effective treatment for cancer?

Research has shown that DPTX3186 targets a specific pathway involved in some cancers, such as stomach cancer. This drug demonstrated strong cancer-fighting effects in lab tests on various stomach cancer cells, particularly in cells with high activity in this pathway, which is common in some tumors. The FDA granted DPTX3186 fast track status due to its promise as a new treatment option. Although information from human studies is limited, these early results suggest it could be a significant breakthrough for people with these types of cancer. Participants in this trial will receive DPTX3186 in a dose escalation study to further evaluate its safety and effectiveness.12567

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors activated by the Wnt pathway, like certain breast, lung, and gastric cancers. Participants must have at least one measurable tumor and no other treatment options available. They should be in good physical condition (ECOG status of 0 or 1) and able to take oral medication.

Inclusion Criteria

I do not have conditions like a colostomy that would prevent me from absorbing pills.
I am 18 years old or older.
My doctor expects me to live for at least 3 more months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DPTX3186 to evaluate safety, pharmacokinetics, and initial activity

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DPTX3186

Trial Overview

The study tests DPTX3186 on patients with Wnt-pathway activated solid tumors. It's a first-in-human trial focusing on safety, how the body processes the drug (pharmacokinetics), its initial effectiveness, and identifying biomarkers for efficacy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dewpoint Therapeutics

Lead Sponsor

Citations

DPTX3186 in Wnt Pathway Activated Solid Tumors

Histologically or cytologically confirmed solid tumor and tumor types known to be Wnt-pathway activated (such as colorectal cancer, gastric ...

FDA Grants Fast Track Designation to DPTX3186 for ...

Demonstrated broad cytotoxicity across diverse gastric cancer cell lines, including those with high Wnt-pathway activation. In vivo efficacy.

FDA Grants Fast Track to Novel C-Mod DPTX3186 in ...

DPTX3186 gains FDA fast track status, promising a novel treatment for gastric cancer with potential for significant patient impact.

FDA Grants Fast Track Designation to DPTX3186 for ...

DPTX3186 targets the Wnt/β-catenin pathway, modulating β-catenin's oncogenic function to treat gastric cancer. · The therapy received fast track ...

Beta catenin c-mods are orally bioavailable small- ...

Figure 2: DPTX3186 exhibits robust cancer cell killing across gastric cancer (GC) cell panel with diverse molecular profiles.

FDA Grants DPTX3186 Orphan Drug Designation for ...

The US Food and Drug Administration (FDA) has awarded DPTX3186 an Orphan Drug Designation for the treatment of patients with gastric cancer.

Evotec-Partner Dewpoint Therapeutics announces an ...

The initial study will evaluate the safety, pharmacokinetics, and preliminary efficacy of DPTX3186 as a single agent, with a focus on metastatic ...