Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

• Status: Recruiting
• Trial end date: 2031-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Presage Biosciences
• Collaborators: Bristol-Myers Squibb; Merck Sharp & Dohme Corp.; Takeda
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Fluorouracil; Ipilimumab; Nivolumab; Paclitaxel; Pembrolizumab

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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 effaced metastatic lymph node) ≥ 2 cm in the shortest diameter that is surface accessible for CIVO injection that may be guided by ultrasound if appropriate and for which there is a planned surgical intervention. Treatment plan my include adjuvant radiation or chemotherapy and patients should have no medical contraindication to surgery.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

7. 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 or effaced nodes that are anticipated by the Investigator to lack a sufficient volume of viable tumor tissue (based on available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports) for CIVO injection due to size, location, necrosis, cysts, excessive stroma, or fibrosis.

2. Patients who have received neoadjuvant therapy associated with the surgical intervention described in Inclusion Criterion #5.

3. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.

4. 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.

5. 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.

6. Patients with a history of concurrent second cancers requiring active, ongoing systemic treatment.

7. Patients with active autoimmune diseases requiring treatment.

8. Patients with known human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) with uncontrolled viral load and CD4 less than 200, or known chronic hepatitis B/C.

9. Patients that have received a live vaccine within 4 weeks of the baseline/screening visit.

10. Use of any of the following ≤ 2 weeks prior to CIVO injection:

1. Chronic systemic immunosuppressive therapy or corticosteroids (e.g., prednisone or equivalent exceeding a total dose of 140 mg over the last 14 days). Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular injection), or steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) are exceptions to this criterion.

2. Biological response modifiers for treatment of active autoimmune disease.

3. Hematopoietic growth factors.