What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly those involving PARP inhibitors like Senaparib, commonly result in hematologic toxicities such as anemia, thrombocytopenia, and neutropenia. Non-hematologic side effects often include nausea, fatigue, and gastrointestinal issues. General chemotherapy agents also frequently cause fatigue, nausea, vomiting, hair loss, and increased infection risk due to bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve molecularly targeted agents and PARP inhibitors. For instance, olaparib, a PARP inhibitor, has been approved for use in various cancers, including ovarian and breast cancer, particularly in patients with BRCA mutations. Similarly, niraparib, another PARP inhibitor, has shown efficacy in prostate cancer with homologous recombination repair deficiencies. These approvals highlight the therapeutic potential of targeting specific molecular pathways in solid tumors, akin to the investigational combination of IMP9064 and Senaparib.

What other types of research exist?

Promising alternatives for solid tumor treatment in 2024 include: 1) Olaparib (PARP inhibitor) combined with abiraterone for metastatic castration-resistant prostate cancer, showing prolonged progression-free survival. 2) Vismodegib (SMO inhibitor) for SHH medulloblastomas, particularly in patients with PTCH1 mutations. 3) Durvalumab (PD-L1 inhibitor) combined with gemcitabine and cisplatin for advanced biliary tract cancer, demonstrating efficacy in recent trials. 4) Lenvatinib combined with transarterial chemoembolization for advanced hepatocellular carcinoma, showing promising results in phase III trials.

← Back to Search

Monoclonal Antibodies

IMP9064 +/- Senaparib for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Impact Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must be ≥ 18 years of age on the day of signing informed consent form

Male or female patients with histologically or cytologically confirmed AST refractory to or intolerant of available standard-of-care therapy or for which no standard treatment exists

Must not have

Live virus or bacterial vaccine within 28 days prior to the first dose of study drug and whilst the patient is receiving study drug

Clinically significant cardiovascular condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called IMP9064, which may stop cancer cells from fixing their damaged DNA. It is aimed at patients with advanced solid tumors who need new treatment options. The medicine works by blocking proteins that help cancer cells repair themselves, making it harder for them to survive.

Who is the study for?

Adults with advanced solid tumors who have not responded to standard treatments or for whom no standard treatment exists. They must be able to perform daily activities with minimal assistance (ECOG 0-1), provide tumor tissue samples, and have a life expectancy of at least 12 weeks. Women must be post-menopausal, not pregnant, and willing to use effective contraception; men should either be vasectomized or agree to use contraception.

What is being tested?

The trial is testing IMP9064 alone or combined with Senaparib in patients with advanced solid tumors. It's an open-label study, meaning both the researchers and participants know what treatment is being given. The goal is to assess how safe and effective these treatments are.

What are the potential side effects?

While specific side effects for IMP9064 are not listed here, common side effects from cancer therapies like this may include fatigue, nausea, diarrhea, skin reactions, blood count changes increasing infection risk, liver function changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My AST cancer doesn't respond to standard treatments or I can't tolerate them.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

Select...

I have not received any live vaccines within the last 28 days.

Select...

I have a serious heart condition.

Select...

I cannot swallow pills.

Select...

I have had myelodysplastic syndrome, acute myeloid leukemia, or a bone marrow transplant.

Select...

I haven't had major surgery, intense radiotherapy, or used radioactive drugs recently.

Select...

I have received treatments targeting the ATR/CHK1 pathway.

Select...

I haven't taken any cancer treatment within the last 28 days or 5 half-lives before starting the study drug.

Select...

My side effects from previous treatments are mild, except for hair loss and low blood count.

Select...

My cancer has spread to my brain or spinal cord and hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (Safety and Tolerability)

To determine the Maximum Tolerable Dose

Secondary study objectives

To assess Disease control rate (DCR)

To assess Duration of response(DOR)

To assess Overall response rate (ORR)

+5 more

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: IMP9064 MonotherapyExperimental Treatment1 Intervention

Dose-escalation IMP9064 administered orally on empty stomach once/twice daily

0 / 12Eligibility 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

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells. Targeted therapies, such as PARP inhibitors like Senaparib, block specific molecules involved in cancer cell growth and survival; PARP inhibitors specifically prevent cancer cells from repairing their DNA, leading to cell death. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the tumor's characteristics and potential resistance mechanisms.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.New and emerging combination therapies for esophageal cancer.Targeting the androgen receptor in the management of castration-resistant prostate cancer: rationale, progress, and future directions.