What side effects are associated with this type of intervention?

Common treatments for solid tumors with HRR gene mutations, such as PARP inhibitors (e.g., rucaparib, niraparib, olaparib), often have side effects including nausea, fatigue, anemia, and vomiting. Serious adverse events can include myelosuppression, which leads to low blood cell counts, and increased risk of infections. Other side effects may include hypertension, diarrhea, and liver function abnormalities. These treatments are generally well-tolerated, but monitoring for these side effects is crucial.

What prior FDA approvals exist?

Several FDA-approved treatments target homologous recombination repair (HRR) gene mutations in solid tumors. Notable examples include PARP inhibitors such as olaparib, rucaparib, and niraparib. Olaparib is approved for BRCA-mutated breast and ovarian cancers, while rucaparib is approved for BRCA-mutated ovarian cancer and is under study for metastatic castration-resistant prostate cancer (mCRPC) with HRR mutations. Niraparib is approved for ovarian cancer and has shown activity in mCRPC with HRR gene abnormalities. These treatments are similar to the investigational drug IMP1734, which is being studied for its efficacy in advanced solid tumors with HRR gene mutations.

What other types of research exist?

Promising alternatives to IMP1734 for solid tumors with HRR gene mutations include: 1) Niraparib, which is being evaluated as a neoadjuvant therapy in advanced ovarian cancer with homologous recombination deficiency (HRD). 2) Rucaparib, which has shown efficacy in metastatic breast cancer with high genomic loss of heterozygosity (LOH) scores. Both drugs are PARP inhibitors and target similar pathways as IMP1734.

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PARP Inhibitor

IMP1734 for Advanced Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Eikon Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of informed consent

Breast cancer patients who have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, received hormonal therapy if HR+

Must not have

Active hepatitis B/C infection

Known predisposition to bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, side effects of IMP1734 might include typical reactions seen with similar drugs like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding tendencies, liver function alterations, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have breast cancer and have had chemotherapy or hormone therapy if my cancer is hormone receptor positive.

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I have had platinum-based chemotherapy for my advanced ovarian, fallopian tube, or peritoneal cancer.

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I am fully active or can carry out light work.

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I have harmful genetic changes in specific DNA repair genes.

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I have had one previous treatment that included a PARP inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active hepatitis B or C infection.

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I am prone to bleeding easily.

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I cannot take pills by mouth or have a condition that affects how my body uses food.

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I have previously taken PARP1 inhibitor medication.

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I do not have active or untreated brain metastases or carcinomatous meningitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maxim Tolerated Dose or Recommended Dose for Expansion

Number of subjects with adverse events, treatment emergent adverse events or serious adverse events

Secondary study objectives

Overall Response Rate

Pharmacokinetic parameters of IMP1734

Other study objectives

Characterization of the pharmacodynamic changes due to IMP1734

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cohort 1Experimental Treatment1 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, especially those targeting homologous recombination repair (HRR) gene mutations, include PARP inhibitors like IMP1734. These inhibitors work by blocking the PARP enzyme, which is crucial for repairing single-strand DNA breaks. In tumors with defective HRR pathways, such as those with BRCA1/2 mutations, this leads to the accumulation of DNA damage, ultimately causing cancer cell death. This mechanism is particularly important for patients with solid tumors because it offers a targeted approach that can be more effective and potentially less toxic than traditional chemotherapy, improving outcomes and quality of life.

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