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Testing microdoses of anti-cancer therapies directly in tumors

A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors

Early Phase 1 Interventional Presage Biosciences · NCT04541108

This study is testing if giving tiny doses of cancer treatments directly into tumors can help doctors understand how well different therapies work for patients with solid tumors before surgery.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Enrollment15 (estimated)
Ages18 Years and up
SexAll
SponsorPresage Biosciences Industry-sponsored
Locations12 sites (Sacramento, California and 11 other locations)
Trial IDNCT04541108 on ClinicalTrials.gov

What this trial studies

This multi-center Phase 0 Master Protocol aims to evaluate the pharmacodynamics of anti-cancer therapies administered intratumorally in microdose quantities using the CIVO device. The CIVO device allows for the simultaneous delivery of multiple anti-cancer agents directly into the tumor, enabling rapid assessment of their effects within the unique tumor microenvironment. By conducting these injections prior to scheduled surgical interventions, the study seeks to gather insights on how different therapies interact with individual tumors and their surrounding tissues. This approach is designed to enhance the drug development process by providing real-time data on treatment responses in patients with solid tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with surface-accessible solid tumors that are scheduled for surgical intervention.

Not a fit: Patients with tumors that are not surface accessible or those who do not have a scheduled surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized cancer treatments by identifying the best therapeutic options for individual patients.

How similar studies have performed: While the approach of using microdoses in the tumor microenvironment is innovative, similar studies have shown promise in evaluating localized treatment responses, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
\*This list is representative of study inclusion/exclusion criteria. Each substudy may include variations on these criteria.

Inclusion Criteria:

1. Ability and willingness to comply with the study's visit and assessment schedule.
2. Male or female ≥ 18 years of age at Visit 1 (Screening).
3. Pathologic diagnosis of \[solid tumors\] indicated in the relevant substudy(ies).
4. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
5. At least one lesion (primary tumor, recurrent tumor, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration.
6. Female patients who:

   * Are postmenopausal for at least one year before the screening visit, OR
   * Are surgically sterile, OR
   * Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) and during study participation OR agree to completely abstain from heterosexual intercourse.
   * Agree to refrain from donating ova during study participation.

Male patients, even if surgically sterile (i.e., status post-vasectomy), who:

* Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse.
* Agree to refrain from donating sperm during study participation.

Exclusion Criteria:

1. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
2. Female patients who are:

   * Both lactating and breastfeeding, OR
   * Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator.
3. 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.

Where this trial is running

Sacramento, California and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorHNSCCSCCHNlymphomasarcomabreast adenocarcinomamelanomaintratumoral microdosing
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.