IMP9064 +/- Senaparib for Solid Tumors

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Impact Therapeutics, Inc.

Must not be taking: Chemotherapy, Immunotherapy, Hormonal therapy, others

Disqualifiers: CNS tumors, Cardiovascular conditions, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic cancer therapy, including chemotherapy, immunotherapy, and hormonal therapy, at least 28 days before starting the study drug. If you are on low-dose corticosteroids, you may still participate, but continuous treatment with proton pump inhibitors or potassium competitive acid blockers is not allowed.

What data supports the effectiveness of the drug IMP9064 +/- Senaparib for solid tumors?

The research mentions olaparib, a drug similar to senaparib, which has shown effectiveness in treating prostate cancer with specific genetic alterations, and has been studied in combination with other treatments for head and neck cancer. This suggests that similar drugs might be effective in treating certain types of cancer.

^{1 2 3 4 5}

What safety data exists for Senaparib in humans?

Senaparib has been studied in humans for safety in patients with advanced solid tumors, showing it is generally safe and tolerable in early trials.

^{2 6 7 8 9}

What makes the drug IMP9064 +/- Senaparib unique for treating solid tumors?

IMP9064 combined with Senaparib is unique because it involves a novel poly(ADP-ribose) polymerase inhibitor, Senaparib, which has shown strong antitumor activity in early studies. This combination may offer a new approach for treating solid tumors by targeting specific pathways involved in cancer cell repair and survival.

^{6 7 10 11 12}

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

Provision of tumor tissue samples

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

Exclusion Criteria

I have a serious heart condition.

I cannot swallow pills.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive IMP9064 monotherapy in a dose-escalation format to determine the Maximum Tolerable Dose

11 months

Dose-expansion

Participants receive IMP9064 monotherapy or in combination with PARP inhibitor Senaparib to evaluate safety and efficacy

11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

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.

Group I: IMP9064 Monotherapy Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

Impact Therapeutics, Inc. Lead Sponsor

References

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

Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial. [2023] Label="PURPOSE" NlmCategory="OBJECTIVE">Phase III PROfound trial (ClinicalTrials.gov identifier: NCT02987543) met its primary and key secondary objectives, demonstrating significantly longer radiographic progression-free survival (rPFS) and overall survival (OS) with olaparib monotherapy versus abiraterone or enzalutamide (control) in patients with metastatic castration-resistant prostate cancer (mCRPC) with alterations in BRCA1, BRCA2 (BRCA), and/or ATM (cohort A) whose disease had progressed on prior next-generation hormonal agent (NHA). We report exploratory post hoc analysis of the subgroup of patients with mCRPC with BRCA alterations in PROfound.

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

Phase II Window Study of Olaparib Alone or with Cisplatin or Durvalumab in Operable Head and Neck Cancer. [2023] We conducted a phase II randomized noncomparative window of opportunity (WOO) trial to evaluate the inhibition of cellular proliferation and the modulation of immune microenvironment after treatment with olaparib alone or in combination with cisplatin or durvalumab in patients with operable head and neck squamous cell carcinoma (HNSCC).

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

Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer. [2021] The large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel-T immunotherapy for asymptomatic/minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

4. England pubmed.ncbi.nlm.nih.gov

Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. [2023] The Phase III PROfound study (NCT02987543) evaluated olaparib versus abiraterone or enzalutamide (control; randomized 2:1 to olaparib or control) in men with homologous recombination repair gene alterations and metastatic castration-resistant prostate cancer whose disease progressed on prior next-generation hormonal agent.

5. England pubmed.ncbi.nlm.nih.gov

PARP inhibitors in the treatment of ovarian cancer: a review. [2023] This article will review recent changes in the standard of care for olaparib, niraparib, and rucaparib, as well as ongoing trials evaluating this class of drugs in combination with antiangiogenic agents and PD-1/PD-L1 inhibitors.

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

A phase 1 dose-escalation study of the poly(ADP-ribose) polymerase inhibitor senaparib in Australian patients with advanced solid tumors. [2023] Senaparib is a novel, selective poly(ADP-ribose) polymerase-1/2 inhibitor with strong antitumor activity in preclinical studies. This first-in-human, phase 1, dose-escalation study examined the safety and preliminary efficacy of senaparib in patients with advanced solid tumors.

7. England pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Senaparib, a Novel PARP1/2 Inhibitor, in Chinese Patients With Advanced Solid Tumors: A Phase I Trial. [2023] Senaparib, a novel poly(ADP-ribose) polymerase 1/2 inhibitor, demonstrated antitumor activity in preclinical studies. This phase I, first-in-human, dose-escalation/-expansion study explored the pharmacokinetics, safety and tolerability, and preliminary antitumor activity of senaparib in Chinese patients with advanced solid tumors.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer. [2022] To systematically evaluate the efficacy and safety of olaparib in the treatment of recurrent platinum-sensitive ovarian cancer.

9. England pubmed.ncbi.nlm.nih.gov

Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. [2022] Cediranib and olaparib combination did not result in clinically meaningful activity in patients with metastatic pancreatic ductal adenocarcinoma without known BRCA mutation.

10. England pubmed.ncbi.nlm.nih.gov

Phase I study to assess the safety and tolerability of olaparib in combination with bevacizumab in patients with advanced solid tumours. [2023] Olaparib (AZD2281) is a potent oral poly(ADP-ribose) polymerase inhibitor with anti-tumour activity and acceptable toxicity as monotherapy in patients with BRCA-deficient cancers. The vascular endothelial growth factor receptor inhibitor bevacizumab has been incorporated into standard of care with chemotherapy in various tumours. This phase I study established the safety, tolerability and clinical pharmacokinetics of olaparib alone and in combination with bevacizumab.

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

Real-world clinical outcomes of olaparib therapy in Chinese patients with advanced serous ovarian cancer treated in Macau. [2021] Olaparib has been approved as an active and maintenance therapy for patients with platinum-sensitive, BRCA-mutated high-grade serous ovarian cancer (SOC). However, the efficacy and safety data is lack among Chinese ovarian cancer patients.

12. Turkey pubmed.ncbi.nlm.nih.gov

Stability Indicating Assay Method for the Quantitative Determination of Olaparib in Bulk and Pharmaceutical Dosage Form. [2022] Olaparib is an orally active poly (ADP-ribose) PARP (polymerases) inhibitor known to destroy cancer cells with BRCA1 or BRCA2 deficiency. An authentic, fast, distinct, and reliable reverse phase-high performance liquid chromatography (RP-HPLC) method was developed and promptly validated in tablet formulations for olaparib estimation.