132 Participants NeededMy employer runs this trial

IDP-001 for Cancer

Recruiting at 6 trial locations
II
Overseen ByInduPro Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: InduPro, Inc.
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 aims to test the safety and potential benefits of a new treatment called IDP-001 for certain advanced or metastatic cancers, such as lung and head and neck cancers. The study will assess patient tolerance to the treatment and its effectiveness in slowing or reducing tumor growth. Suitable candidates have advanced cancer that cannot be treated with surgery or approved treatments and are willing to undergo tumor biopsies (small tissue samples). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer based on your specific situation.

Is there any evidence suggesting that IDP-001 is likely to be safe for humans?

Research shows that IDP-001 is under evaluation for its safety and effectiveness in treating advanced squamous cell cancers. Early studies indicate that IDP-001, designed to specifically target cancer cells, has been tested in animals. These studies suggest it can attack cancer cells without harming normal cells. As the current trial is in its early stages, researchers are closely monitoring for any side effects and learning how the treatment works in the body. This phase is crucial to ensure the treatment's safety for humans. Reaching this stage means the treatment has shown promise in earlier tests, but more information on its safety in humans is still needed.12345

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about IDP-001 because it offers a fresh approach to treating advanced or metastatic solid tumors. Unlike conventional treatments like chemotherapy, which attack both cancerous and healthy cells, IDP-001 is designed to target and disrupt specific tumor cells, potentially leading to fewer side effects. This treatment is administered as an intravenous infusion, allowing direct delivery to the bloodstream and potentially enhancing its efficacy. By focusing on a precise mechanism of action, IDP-001 could provide a more effective and targeted option for patients with these challenging cancer types.

What evidence suggests that IDP-001 might be an effective treatment for cancer?

Research has shown that IDP-001 may help combat advanced or spreading squamous cell cancers. This treatment represents a new class of drugs that targets two specific markers on cancer cells, allowing for more precise attacks. Early lab tests demonstrated that IDP-001 effectively kills cancer cells with varying levels of these markers. Other studies have found that IDP-001 can also enhance the body's natural immune response against tumors. While these results are promising, further research is needed to confirm its effectiveness in humans. Participants in this trial will receive IDP-001 as an intravenous infusion in different phases to evaluate its safety and effectiveness.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, such as certain lung, head and neck, esophageal, cervical, anal, or skin cancers. Participants must be in good physical condition (ECOG 0-1), have measurable disease, adequate organ function, a life expectancy over 12 weeks, and agree to use contraception.

Inclusion Criteria

* Agree to contraception requirements as outlined in the protocol
* Life expectancy greater than 12 weeks
I have tumors that can be measured by scans or exams.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Part 1 Dose Escalation

Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion

8-12 weeks

Phase 1 Part 2 Indication Selection

Participants with a single tumor indication will receive IDP-001 as IV infusion

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IDP-001

Trial Overview

The study is testing a new drug called IDP-001 to see if it is safe and how well it works against various advanced or spreading squamous cell cancers. Researchers will monitor side effects and early signs of effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 1 Part 2 Indication SelectionExperimental Treatment1 Intervention
Group II: Phase 1 Part 1 Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

InduPro, Inc.

Lead Sponsor

Citations

A Study of IDP-001 in Advanced or Metastatic Solid Tumors

This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced ...

Abstract 2933: IDP-001 is a potent bispecific ADC with in vivo ...

IDP-001 is a first-in-class bispecific ADC with the potential for broad therapeutic activity and best-in-class efficacy.

IDP-001 for Cancer · Info for Participants

The study is testing a new drug called IDP-001 to see if it is safe and how well it works against various advanced or spreading squamous cell cancers.

A Study of IDP-001 in Advanced or Metastatic Solid Tumors

This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced ...

Targeting intrinsically disordered proteins involved in cancer

In this review, we provide and discuss recent examples of IDPs, involved at different stages in several kinds of cancers, which have been successfully targeted ...

A Phase 1/2 Open-label Study of IDP-001 in Advanced or ...

This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in ...