IMP1734 for Advanced Solid Tumors

Recruiting at 57 trial locations

Overseen By Ivan Sanchez

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eikon Therapeutics

Must be taking: ADT

Must not be taking: PARP1 inhibitors

Disqualifiers: CNS metastases, Hepatitis B/C, others

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

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, IMP1734, for individuals with advanced or metastatic breast, ovarian, or prostate cancer. The goal is to determine if IMP1734 can effectively treat these cancers in patients with specific genetic mutations affecting DNA repair. Participants should have received prior treatment for their cancer but still require management. Those with these cancer types and a specific genetic profile might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop any investigational or approved anti-cancer therapies at least 28 days before starting the study medication. However, if you have metastatic castrate-resistant prostate cancer, you must continue ongoing androgen deprivation therapy (ADT).

Is there any evidence suggesting that IMP1734 is likely to be safe for humans?

Research shows that IMP1734, also known as EIK1003, targets a specific protein that helps cancer cells repair themselves, potentially stopping tumor growth. Previous studies have demonstrated that this treatment can effectively slow tumor growth in lab tests. Since the trial under consideration is in its early stages (Phase 1/2), researchers are still closely monitoring and understanding the drug's safety in humans.

Detailed safety data for humans is not yet available, but advancing to this phase suggests that initial tests did not reveal major safety concerns. While side effects may still occur, safety remains a top priority. A dedicated Safety Monitoring Committee regularly reviews new safety information. For those considering joining this trial, it may be reassuring to know that safety is being carefully monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

IMP1734 is unique because it targets advanced solid tumors with a fresh approach. Unlike current treatments, which often involve chemotherapy or radiation, IMP1734 is an oral tablet designed for daily use, making it potentially more convenient for patients. Researchers are excited because it promises a new mechanism of action that could offer hope for those who have not responded to traditional therapies. With the possibility of fewer side effects and a more targeted attack on cancer cells, IMP1734 stands out as a promising candidate in the fight against advanced solid tumors.

What evidence suggests that IMP1734 might be an effective treatment for advanced solid tumors?

Research has shown that IMP1734, the treatment under study in this trial, could be a promising option for some advanced cancers. IMP1734 blocks a protein called PARP1, which aids cancer cells in repairing damaged DNA. By halting this repair process, cancer cells can die. Studies suggest this method might be effective for tumors with certain genetic changes, often found in breast, ovarian, and prostate cancers. Early results indicate that IMP1734 might enable more effective treatment with fewer side effects. Although more research is needed, these findings offer hope for people with cancers linked to specific genetic mutations. ^{1 2 5 6 7}

Who Is on the Research Team?

Viola Chen, MD

Principal Investigator

Eikon Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced breast, ovarian, or prostate cancer that has spread and have specific gene mutations. They must have tried platinum-based chemo (for ovarian cancer) or one chemo in any setting (for breast cancer), and may have had a PARP inhibitor before. Men must be on hormone therapy for prostate cancer and could've had taxane chemotherapy. All participants need to use birth control during the study.

Inclusion Criteria

Life expectancy ≥ 12 weeks

My organs are working well.

Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA

Exclusion Criteria

I have an active hepatitis B or C infection.

Mean resting QTcF > 470 ms or QTcF < 340 ms

I am prone to bleeding easily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumors

Up to 3 years

Dose Optimization

Evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of IMP1734

Up to 3 years

Dose Expansion

Evaluate the recommended dose escalation (RDE) of IMP1734 monotherapy in patients with specific cancer types

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

• IMP1734

Trial Overview The trial tests IMP1734's effectiveness specifically in patients with certain types of advanced cancers—breast, ovarian, or prostate—that are resistant to previous treatments and carry particular genetic mutations affecting DNA repair.

How Is the Trial Designed?

Group I: Cohort 1 Experimental Treatment 1 Intervention

IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.

Who Is Running the Clinical Trial?

Eikon Therapeutics

Lead Sponsor

Trials

8

Recruited

1,300+

Impact Therapeutics, Inc.

Industry Sponsor

Trials

15

Recruited

1,600+

Published Research Related to This Trial

EGFR-TKIs have significantly improved survival rates for patients with metastatic non-small cell lung cancer (NSCLC) who have EGFR mutations, but resistance to these treatments remains a challenge, leading to the exploration of novel combination therapies.

Current evidence suggests that immune checkpoint inhibitors (ICIs) have not provided survival benefits for EGFRm NSCLC patients due to factors like low PD-L1 expression and alternative immune escape mechanisms, although recent studies indicate potential benefits when combined with chemotherapy in TKI-resistant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of immunotherapy in metastatic EGFRm NSCLC: Is it relevant? Dhabhar, B., Sahoo, TP., Akshay, JK.[2022]

In a study of 232 patients with advanced non-small cell lung cancer (NSCLC), having more metastatic sites was linked to worse progression-free survival (PFS) and overall response rates to immune checkpoint inhibitors (ICIs).

Liver metastasis (LM) was identified as a significant negative predictor for PFS in patients receiving ICI treatment, but combination therapy showed promise in improving outcomes for those with LM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of immune-checkpoint inhibitors in advanced non-small cell lung cancer patients with different metastases. Qiao, M., Zhou, F., Hou, L., et al.[2022]

In a study of 65 patients undergoing interventional oncology therapies combined with immune checkpoint inhibitors, only 10.8% experienced immune-related adverse events (irAEs), mostly mild and manageable, indicating a favorable safety profile for this combination treatment.

The study found no severe complications (grade 5) related to the procedures or irAEs within 90 days, suggesting that combining tumor-directed therapies with immune checkpoint inhibitors is safe and does not lead to unexpected toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. Leppelmann, KS., Mooradian, MJ., Ganguli, S., et al.[2021]

Combination therapies using immune checkpoint inhibitors (ICIs) have shown improved overall survival and response rates in metastatic renal cell carcinoma (mRCC), with four out of six trials outperforming the standard treatment, sunitinib.

While these combinations, such as nivolumab with ipilimumab, have demonstrated significant efficacy, not all patients respond, highlighting the need for predictive biomarkers and new treatment strategies to address these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent pharmacological approaches for the treatment of renal cell carcinoma. Alimohammadi, A., Fajkovic, H., Remzi, M., et al.[2022]

In a review of 5 randomized trials involving advanced non-small cell lung carcinoma (NSCLC) patients, only pembrolizumab, either alone or with chemotherapy, showed a potential improvement in overall survival compared to chemotherapy alone, although the significance was borderline.

Other immune checkpoint inhibitors like nivolumab, atezolizumab, and durvalumab did not demonstrate any survival advantage, indicating that pembrolizumab may be the most effective first-line treatment option for patients with wild-type EGFR or ALK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restricted mean survival time in advanced non-small cell lung cancer treated with immune checkpoint inhibitors. Di Spazio, L., Cancanelli, L., Rivano, M., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3122

Safety and efficacy of EIK1003, a selective PARP1 inhibitor ... EIK1003 (IMP1734) is a potent PARP1-selective inhibitor that may widen the therapeutic index in susceptible tumors.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06253130

NCT06253130 | A First-in-human Study of PARP1 ... This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT06253130

A First-in-human Study of PARP1 Selective Inhibitor ... ... IMP1734, in Participants With Advanced Solid Tumors. P1/2. Eikon Therapeutics ... posters will spotlight new first-in-human and combination data from Eikon's two ...

4. impacttherapeutics.com impacttherapeutics.com/en/new/180.html

IMPACT Announces FPD in U.S. of PARP1 selective inhibitor IMPACT Therapeutics announced that the first patient in the United States has been treated with EIK1003 (formerly IMP1734), a PARP1 selective inhibitor.

5. eikontx.com eikontx.com/news/eikon-therapeutics-to-share-clinical-data-and-program-updates-at-the-2025-asco-annual-meeting/

Eikon Therapeutics to Share Clinical Data and Program ... This trial is assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, ...

6. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/eik1003-001-a-first-in-human-study-of-imp1734-in-patients-with-advanced-solid-tumors/

EIK1003-001: A first-in-human study of IMP1734, in ... The Safety Monitoring Committee (SMC) will be set up separately to review the safety, efficacy, PK, and/or PD data for Part 1, Part 2, and Part 3 of the study ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3191

A first-in-human (FIH), phase 1/2, dose-escalation ... IMP1734 (EIK1003) is a potent PARP1-selective inhibitor that inhibits tumor growth in nonclinical models and may widen the therapeutic index.