IMP1734 for Advanced Solid Tumors

Recruiting at 23 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Eikon Therapeutics

Must be taking: ADT

Must not be taking: PARP1 inhibitors

Disqualifiers: CNS metastases, Hepatitis B/C, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called IMP1734 in patients with advanced breast, ovarian, and prostate cancers that have specific genetic mutations. The drug aims to block the cancer cells' ability to repair their DNA, which could stop the cancer from growing.

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).

What data supports the effectiveness of the drug IMP1734 for Advanced Solid Tumors?

Research shows that combining immune checkpoint inhibitors (ICIs) with other treatments, like tyrosine kinase inhibitors (TKIs), can improve survival and response rates in certain cancers, such as renal cell carcinoma. This suggests that similar combinations might be effective for other advanced solid tumors, although more research is needed to confirm this. ^{1 2 3 4 5}

Research Team

Viola Chen, MD

Principal Investigator

Eikon Therapeutics

Eligibility Criteria

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

I am 18 years old or older.

My organs are working well.

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.

Trial Timeline

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

Treatment Details

Interventions

• IMP1734 (PARP Inhibitor)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Role of immunotherapy in metastatic EGFRm NSCLC: Is it relevant? [2022]

2. China pubmed.ncbi.nlm.nih.gov

Efficacy of immune-checkpoint inhibitors in advanced non-small cell lung cancer patients with different metastases. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Recent pharmacological approaches for the treatment of renal cell carcinoma. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Restricted mean survival time in advanced non-small cell lung cancer treated with immune checkpoint inhibitors. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. [2021]