Intratumoral Microdosing for Cancer

Recruiting at 10 trial locations

Overseen By Roxanne Moore

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Presage Biosciences

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

15 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 5 6}

What 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. ^{1 2 3 4 5}

Research Team

Study Director

Principal Investigator

Presage Biosciences

Eligibility 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.

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.

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

Treatment Details

Interventions

• 5-FU
• Carboplatin
• CIVO Intratumoral Microdosing
• Ipilimumab
• Nivolumab
• Paclitaxel
• Pembrolizumab

Trial Overview 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.

Participant Groups

Group I: Rilvegostomig, Volrustomig, Sabestomig, Pembrolizumab Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Presage Biosciences

Lead Sponsor

Trials

10

Recruited

110+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

CIVO technology allows for the simultaneous analysis of up to 8 different therapies directly within a patient's tumor, providing a more accurate understanding of how tumors respond to treatments.

This method avoids systemic toxicity and preserves the natural tumor microenvironment, making it a safer and more effective way to study cancer therapies in real patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting responses to chemotherapy in the context that matters - the patient. Moreno-Gonzalez, A., Olson, JM., Klinghoffer, RA.[2020]

The Comparative In Vivo Oncology (CIVO) system was found to be safe and feasible in a pilot study involving 13 patients with soft tissue sarcoma, with only minor, transient adverse events reported.

CIVO allowed for the simultaneous testing of multiple microdoses of anticancer drugs directly in the tumor, showing consistent drug responses that align with known mechanisms of action, which could enhance early evaluation of new cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. Gundle, KR., Deutsch, GB., Goodman, HJ., et al.[2021]

The CIVO technology platform allows for the simultaneous assessment of multiple cancer drugs directly within a single tumor, providing a more accurate representation of drug efficacy compared to traditional in vitro models.

In studies using CIVO, localized drug responses were observed that predicted systemic drug effectiveness, revealing important insights into tumor resistance and sensitivity, which could lead to more effective personalized cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technology platform to assess multiple cancer agents simultaneously within a patient's tumor. Klinghoffer, RA., Bahrami, SB., Hatton, BA., et al.[2022]

Microdosing, which involves administering a very small dose of a drug (1% of the pharmacologic dose or 100 µg), has shown that about 80% of orally tested drugs and 100% of intravenously tested drugs maintain predictable pharmacokinetics (PK) between microdoses and therapeutic doses, which is crucial for drug development.

Recent advancements in microdosing techniques have expanded its applications, including in pediatrics and localized treatments, suggesting it may offer a more effective way to understand drug behavior in humans before moving to larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The expanding utility of microdosing. Lappin, G.[2018]

In a phase 0 clinical trial involving 12 patients with head and neck carcinoma, the investigational drug subasumstat was shown to effectively inhibit the SUMO pathway and induce an immune response within localized tumor regions, demonstrating its potential efficacy in treating cancer.

The innovative combination of trackable intratumor microdosing and spatial biology allowed researchers to assess the drug's effects directly in patient tumors, revealing specific mechanisms of action such as cell cycle inhibition and a shift in the tumor microenvironment from immune-suppressive to immune-permissive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment. Derry, JMJ., Burns, C., Frazier, JP., et al.[2023]

Microdosing allows researchers to test potential drug compounds in humans before Phase I trials, helping to identify ineffective drugs early in the development process and streamline the drug pipeline.

This method provides valuable data on how drugs are absorbed and distributed in the body, potentially reducing development timelines and costs, although more research is needed to fully understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdosing in early lead discovery. Jekunen, AP., Pauwels, EK., Kairemo, KJ.[2010]

References

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

Predicting responses to chemotherapy in the context that matters - the patient. [2020]

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

Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. [2021]

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

A technology platform to assess multiple cancer agents simultaneously within a patient's tumor. [2022]

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

The expanding utility of microdosing. [2018]

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

Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Microdosing in early lead discovery. [2010]