Study of the effect and tolerability of INT230-6 by direct injection into the tumor, followed by neoadjuvant treatment with chemoimmunotherapy in patients with early-stage triplenegative breast cancer: open-label, randomized phase II study involving two groups of participants (cohorts)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Swiss Cancer Institute

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Intensity Therapeutics · Sakk

External identifiers

EU CT number

2024-512511-49-00

ClinicalTrials.gov

NCT06358573

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of this study is to determine the clinical activity of intratumoral INT230-6 in patients with early TNBC.

Secondary objectives 1

1. The secondary objectives of this study are to determine the safety of intratumoral INT230-6 in patients with early TNBC, and to determine translational aspects of its mechanism-of-action.

Conditions and MedDRA coding

Early triple-negative breast cancer (TNBC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Newly histologically diagnosed, previously untreated locally advanced nonmetastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologist (CAP) guidelines
2. The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.
3. Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess the eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus.
4. Measurable disease in the breast with at least one lesion with a diameter ≥2cm1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable.
5. Male or female subject Age ≥ 18 years.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
7. Adequate bone marrow function, hepatic and renal function
8. Negative pregnancy test (for women only)
9. Sufficient cardiac function

Exclusion criteria 12

1. Inflammatory Breast Cancer cT4d
2. Prior chemotherapy, targeted therapy, radiation therapy or anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.
3. Concurrent bilateral breast cancer
4. Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial.
5. Known history of human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
6. Active autoimmune disease that required systemic treatment in the past 2 years
7. History of (non-infectious) pneumonitis and tuberculosis.
8. Known history of allogeneic organ or stem cell transplant.
9. Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration.
10. Concomitant anticoagulation with warfarin or equivalent vitamin K antagonist, direct thrombin inhibitors or platelet inhibitors/antiplatelet agents that cannot be stopped 24 hours before the administration of IMP.
11. Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB).
12. Known hypersensitivity to trial drug or to any component of the trial drug.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0).

Secondary endpoints 9

1. pCR (invasive and in-situ, only invasive, respectively) in the breast
2. pCR in lymph nodes
3. Pattern of non pCR
4. Radiological response according to RECIST v1.1
5. Radiological tumor response using two perpendicular diameters
6. EFS
7. Rate of breast conserving surgery (BCS) at the time of definitive surgery
8. Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment
9. Adverse events according to National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Swiss Cancer Institute

Sponsor organisation

Swiss Cancer Institute

Address

Effingerstrasse 33

City

Bern

Postcode

3008

Country

Switzerland

Scientific contact point

Organisation

Swiss Group for Clinical Cancer Research

Contact name

Clinical Project Manager

Public contact point

Organisation

Swiss Group for Clinical Cancer Research

Contact name

Clinical Project Manager

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications