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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, IMP9064, to see if it is safe and effective when used alone or with another cancer drug, Senaparib.

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.Check my eligibility
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.See study design
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
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I am 18 years old or older.
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My AST cancer doesn't respond to standard treatments or I can't tolerate them.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (Safety and Tolerability)
To determine the Maximum Tolerable Dose
Secondary outcome measures
To assess Disease control rate (DCR)
To assess Duration of response(DOR)
To assess Overall response rate (ORR)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMP9064 MonotherapyExperimental Treatment1 Intervention
Dose-escalation IMP9064 administered orally on empty stomach once/twice daily

Find a Location

Who is running the clinical trial?

Impact Therapeutics, Inc.Lead Sponsor
14 Previous Clinical Trials
1,543 Total Patients Enrolled

Media Library

IMP9064 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05269316 — Phase 1
Solid Tumors Research Study Groups: IMP9064 Monotherapy
Solid Tumors Clinical Trial 2023: IMP9064 Highlights & Side Effects. Trial Name: NCT05269316 — Phase 1
IMP9064 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269316 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a broad array of medical centers in the US that are conducting this experimentation?

"This study is recruiting patients in several places, such as the Mount Sinai hospital in New york, Greenville Hospital System University Medical Center (ITOR) found in Greenville, and Mary Crowley Cancer Research Centers located in Dallas. Additionally, 4 other locations are also participating."

Answered by AI

What is the approximate size of the sample group participating in this clinical investigation?

"Affirmative. According to the clinicaltrials.gov portal, this trial is presently seeking participants; it was originally listed on February 11th 2022 and has recently been revised on July 7th 2022. The medical study requires 61 patients from 4 distinct sites for completion."

Answered by AI

What objectives are researchers hoping to achieve with this medical experiment?

"This clinical trial, which is expected to last 11 months, aims to evaluate the safety and tolerability of a certain drug (IMP9064). Secondary objectives include evaluating overall survival rates according to RECIST version 1.1 in AST patients; analyzing plasma concentration data using non-linear mixed effects modelling via NONMEM; and determining the overall response rate based on RECIST criteria for those same AST subjects."

Answered by AI

Has recruitment for this medical experiment begun?

"Affirmative. Clinicaltrials.gov displays that the trial, which was launched on February 11th 2022 and most recently modified on July 7th 2022 is currently enlisting 61 individuals from 4 locations."

Answered by AI

Has the FDA given its blessing to IMP9064?

"Due to the limited amount of safety and efficacy data that is available, IMP9064 received a score of 1 on our team's risk assessment scale."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Mary Crowley Cancer Research Centers
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
2022. "Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05269316.
~22 spots leftby Jul 2025
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