Intratumoral Microdosing for Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Presage Biosciences
Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled illness, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial uses a device to inject small amounts of cancer drugs directly into tumors of patients undergoing surgery. The device marks where each drug is injected, allowing researchers to see how different parts of the tumor respond. This helps test cancer drugs early without causing widespread side effects. The device has been shown to induce strong, easily tracked, drug-specific responses in tumors while avoiding toxicity, setting the stage for its application in clinical trials.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug used in the Intratumoral Microdosing for Cancer trial?
The CIVO platform allows for the testing of multiple cancer drugs directly in a patient's tumor, providing early insights into drug activity without causing widespread side effects. This method has shown promise in predicting how tumors will respond to drugs, as seen in studies with animal models and human patients, suggesting it could help identify effective treatments more accurately.
12345Is intratumoral microdosing for cancer generally safe in humans?
Research on intratumoral microdosing, specifically using the CIVO platform, shows that it is generally safe in humans. Studies indicate that this method allows for testing multiple cancer drugs directly in tumors without causing harmful side effects throughout the body.
12356What makes the CIVO Intratumoral Microdosing treatment unique for cancer?
CIVO Intratumoral Microdosing is unique because it allows multiple cancer drugs to be tested directly within a patient's tumor at the same time, without causing widespread side effects. This approach helps predict how the tumor will respond to different treatments while preserving the natural tumor environment.
12345Eligibility Criteria
Adults with surface accessible solid tumors scheduled for surgery can join. They must be able to follow the study plan and agree to use effective contraception or abstain from sex. Excluded are those with tumors near critical structures, pregnant or breastfeeding women, and anyone with serious illnesses that could affect participation.Inclusion Criteria
Ability and willingness to comply with the study's visit and assessment schedule
My cancer type matches one of the study's specific cancer types.
I am willing and able to sign a consent form for the study.
+4 more
Exclusion Criteria
My doctor thinks it's too risky to inject my tumor due to its location.
Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
I am currently breastfeeding or have tested positive for pregnancy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intratumoral microdoses of anti-cancer therapies using the CIVO device
1 week
1 visit (in-person)
Surgical Intervention
Surgical excision of the tumor is performed to assess tumor responses to the microdoses
4 hours to 7 days after microdose injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests how anti-cancer drugs like Pembrolizumab and its combinations work inside tumors when given in tiny amounts using a device called CIVO before surgical removal of the tumor. It aims to understand drug effects directly within the tumor environment.
1Treatment groups
Experimental Treatment
Group I: Rilvegostomig, Volrustomig, Sabestomig, PembrolizumabExperimental Treatment4 Interventions
HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, and pembrolizumab alone.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North CarolinaChapel Hill, NC
UT HealthHouston, TX
Sarah Cannon Research InstituteCharleston, SC
Wake Forest Baptist HealthWinston-Salem, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Presage BiosciencesLead Sponsor
TakedaIndustry Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
Predicting responses to chemotherapy in the context that matters - the patient. [2020]Guided by the belief that the most important setting for understanding tumor response to drugs is the human patient, we developed a technology called CIVO. CIVO enables analysis of up to 8 therapies simultaneously in a patient's tumor, without inducing systemic toxicity and while maintaining the integrity of the native tumor microenvironment.
Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. [2021]Label="PURPOSE">A persistent issue in cancer drug development is the discordance between robust antitumor drug activity observed in laboratory models and the limited benefit frequently observed when patients are treated with the same agents in clinical trials. Difficulties in accurately modeling the complexities of human tumors may underlie this problem. To address this issue, we developed Comparative In Vivo Oncology (CIVO), which enables in situ investigation of multiple microdosed drugs simultaneously in a patient's tumor. This study was designed to test CIVO's safety and feasibility in patients with soft tissue sarcoma (STS).
A technology platform to assess multiple cancer agents simultaneously within a patient's tumor. [2022]A fundamental problem in cancer drug development is that antitumor efficacy in preclinical cancer models does not translate faithfully to patient outcomes. Much of early cancer drug discovery is performed under in vitro conditions in cell-based models that poorly represent actual malignancies. To address this inconsistency, we have developed a technology platform called CIVO, which enables simultaneous assessment of up to eight drugs or drug combinations within a single solid tumor in vivo. The platform is currently designed for use in animal models of cancer and patients with superficial tumors but can be modified for investigation of deeper-seated malignancies. In xenograft lymphoma models, CIVO microinjection of well-characterized anticancer agents (vincristine, doxorubicin, mafosfamide, and prednisolone) induced spatially defined cellular changes around sites of drug exposure, specific to the known mechanisms of action of each drug. The observed localized responses predicted responses to systemically delivered drugs in animals. In pair-matched lymphoma models, CIVO correctly demonstrated tumor resistance to doxorubicin and vincristine and an unexpected enhanced sensitivity to mafosfamide in multidrug-resistant lymphomas compared with chemotherapy-naïve lymphomas. A CIVO-enabled in vivo screen of 97 approved oncology agents revealed a novel mTOR (mammalian target of rapamycin) pathway inhibitor that exhibits significantly increased tumor-killing activity in the drug-resistant setting compared with chemotherapy-naïve tumors. Finally, feasibility studies to assess the use of CIVO in human and canine patients demonstrated that microinjection of drugs is toxicity-sparing while inducing robust, easily tracked, drug-specific responses in autochthonous tumors, setting the stage for further application of this technology in clinical trials.
The expanding utility of microdosing. [2018]The concept of microdosing has been around for more than a decade. It consists of the subpharmacologic administration of an investigational drug (1% of the pharmacologic dose or 100 µg, whichever is lower) to human subjects to attain pre-phase 1 pharmacokinetics (PK) in humans. The major concern with microdosing has been the potential for nonlinear PK between doses, but methods are emerging to evaluate the potential for nonlinear PK prior to conducting a study. Currently, approximately 80% of drugs tested by the oral route and 100% by the intravenous route have exhibited scalable PK between a microdose and a therapeutic dose (within a factor of 2). Over the past few years microdosing has found utility in pediatrics, protein-based therapeutics, and a new application known as intra-arterial microdosing that focuses more on localized pharmacodynamics than PK. Compared with other PK predictive methods, such as physiologically based pharmacokinetic modeling, allometry, and in vitro-in vivo extrapolation, microdosing appears to provide a significantly better understanding of PK prior to phase 1, albeit within what is currently a limited database.
Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment. [2023]Cancer drug development is currently limited by a paradigm of preclinical evaluation that does not adequately recapitulate the complexity of the intact human tumor microenvironment (TME). To overcome this, we combined trackable intratumor microdosing (CIVO) with spatial biology readouts to directly assess drug effects in patient tumors in situ.
Microdosing in early lead discovery. [2010]Microdosing provides a tool to enhance drug development by initiating human studies prior to Phase I studies. The purpose is to assist in the go versus no-go decision-making process and to eliminate early ineffective compounds from the drug pipeline. Selection of multiple potential leads can be performed at the clinical stage instead of in preclinical studies. The microdosing approach can be easily used for a molecularly targeted potential drug compound with a known mechanism of action. It provides useful data regarding accessibility and biodistribution that can be used in many estimations benefiting the development of the molecule. In addition, steady state and genetic investigations are becoming possible. Microdosing has a sparing effect on timelines and costs, however, the real importance is not yet known because, although it is known to be widely performed, only a few original reports have been published.