IDE849 for Small Cell Lung Cancer

Recruiting at 9 trial locations

Overseen By IDEAYA Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: IDEAYA Biosciences

Must not be taking: CYP3A4 inhibitors, CYP2D6 inhibitors

Disqualifiers: CNS metastasis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called IDE849, a potential drug for individuals with small cell lung cancer (SCLC) that has returned or worsened after previous treatments. The researchers aim to determine the safety and effectiveness of IDE849 by testing different doses to identify the most effective one. Participants should have SCLC that no longer responds to standard treatments and must have at least one measurable tumor. As a Phase 1 and Phase 2 trial, this study focuses on understanding how IDE849 works in people and measuring its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this potential new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot have had chemotherapy within 4 weeks, immunotherapy within 2 weeks, or certain other treatments within 2 weeks before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that IDE849 is likely to be safe for humans?

Research shows that IDE849, a treatment under study for small cell lung cancer, has been generally safe for patients. In earlier studies, IDE849 was tested on individuals whose small cell lung cancer had returned, and it met acceptable safety standards. Although some side effects occurred, healthcare providers found them manageable.

These studies included a large number of patients, providing valuable insights into how the treatment affects people. It is important to note that IDE849 remains in the early testing stages, primarily focusing on ensuring safety. While the treatment appears promising, researchers continue to monitor it closely to understand all possible effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for small cell lung cancer (SCLC) involve chemotherapy and radiation, which target rapidly dividing cells. But IDE849 works differently, targeting specific proteins involved in cancer cell growth, potentially leading to more precise treatment. Researchers are excited about IDE849 because it might offer a more targeted approach, reducing damage to healthy cells and minimizing side effects compared to traditional treatments. This could mean more effective management of SCLC with fewer unpleasant symptoms for patients.

What evidence suggests that IDE849 might be an effective treatment for small cell lung cancer?

Research has shown that IDE849 may effectively treat small cell lung cancer (SCLC). In one study, 80% of patients who received IDE849 as a second treatment for SCLC experienced tumor shrinkage, with 70% having confirmed results. Another group showed a 73.7% response rate, with 57.9% confirmed. This indicates that many patients experienced significant tumor reduction. In this trial, participants will receive IDE849 in varying doses to determine the optimal treatment strategy. IDE849 targets DLL3, a protein often found in these cancer cells, which might explain its success. These findings suggest that IDE849 could be a strong option for treating this challenging type of cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This clinical trial is for individuals with tumors that express a protein called DLL3, including those with Small Cell Lung Cancer (SCLC). Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

Have at least 1 measurable lesion according to RECIST version 1.1

Have life expectancy > 3 months

Women of childbearing potential must agree to take highly effective contraceptive measures

Exclusion Criteria

Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test

I have not had significant bleeding in the last 3 months.

My lung cancer is a mix of small cell and non-small cell types.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Dose Escalation

Successive cohorts of subjects will be treated with increasing doses of IDE849 until the maximum tolerated dose is reached or the safety of a lower dose(s) is established

Approximately 2 years

Phase 2 - Dose Optimization/Expansion

Subjects enrolled in Part 2 will be assigned to one of the dose levels being evaluated for dose optimization

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IDE849

Trial Overview The study is testing IDE849's safety and effectiveness in treating DLL3-expressing tumors. It's also looking at how the body processes the drug (pharmacokinetics) and its potential to cause immune reactions (immunogenicity).

How Is the Trial Designed?

Group I: Part 2 Dose Optimization/Expansion Experimental Treatment 1 Intervention

Chosen doses of IDE849 will be tested in additional participants for dose optimization and expansion.

Group II: Part 1 Dose Escalation Experimental Treatment 1 Intervention

Successive cohorts of participants will be treated with increasing doses of IDE849 until the maximum tolerated dose is determined.

Who Is Running the Clinical Trial?

IDEAYA Biosciences

Lead Sponsor

Trials

6

Recruited

1,300+

Citations

1. ir.ideayabio.com ir.ideayabio.com/2025-09-07-IDEAYA-Biosciences-and-Hengrui-Pharma-Present-Positive-Phase-1-Data-for-IDE849-SHR-4849-,-a-Potential-First-in-Class-DLL3-TOP1-ADC,-in-Small-Cell-Lung-Cancer-at-the-IASLC-2025-World-Conference-on-Lung-Cancer

News Releases 1. Key data highlights from the presentation. Efficacy (n=71 evaluable SCLC patients treated with IDE849). View News Release Full Screen ...

2. prnewswire.com prnewswire.com/news-releases/ideaya-biosciences-and-hengrui-pharma-present-positive-phase-1-data-for-ide849-shr-4849-a-potential-first-in-class-dll3-top1-adc-in-small-cell-lung-cancer-at-the-iaslc-2025-world-conference-on-lung-cancer-302548425.html

IDEAYA Biosciences and Hengrui Pharma Present Positive ... 80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07174583

NCT07174583 | A Study of IDE849 in Patients With DLL3 ... This study is designed as a multi-stage Phase 1 study within a Phase 2 study. Phase 1 (Part 1 - Dose Escalation): successive cohorts of ...

4. iaslc.org iaslc.org/iaslc-news/press-release/first-human-trial-shows-promising-results-dll3-targeted-antibody-drug

First-in-Human Trial Shows Promising Results for DLL3 ... Small cell lung cancer has limited treatment options and poor prognosis. SHR-4849 consists of a humanized anti-DLL3 IgG1 monoclonal antibody ...

5. onclive.com onclive.com/view/shr-4849-shows-activity-with-manageable-safety-in-relapsed-small-cell-lung-cancer

SHR-4849 Shows Activity With Manageable Safety in ... SHR-4849 showed acceptable safety and preliminary antitumor activity in relapsed small cell lung cancer.