Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label radioligand imaging study evaluating [68Ga]Ga-DWJ155 (FKL480) in adults with advanced gastroesophageal adenocarcinoma, HR+/HER2- or HER2+ advanced breast cancer, TNBC, and advanced NSCLC. The study plans to characterize biodistribution, tumor uptake, dosimetry, safety, and pharmacokinetics, and to identify optimal imaging time points. It consists of an imaging characterization part, with a potential expansion part if tumor uptake is positive. Each participant will undergo a single imaging day with up to 28 days screening, followed by safety follow-up for 3 days, for a total study duration of about 32 days per participant.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age ≥ 18 years old
* Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients with one of the following indications:

  * HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
  * aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
  * aGEA: regardless of any prior systemic line of therapy

Key Exclusion Criteria:

* Out-of-range laboratory values defined as:

  * Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) \< 40 mL/min/1.73m2
  * Platelet count \< 75 x 10\^9/L
  * Hemoglobin \< 9 g/dL
  * Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L
* Patients with inadequate hepatic function
* Urinary tract obstruction or urinary incontinence
* Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  Darlinghurst, New South Wales, Australia Recruiting
• Novartis Investigative Site
  Kyoto, Japan Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New oral medicine PF-08032562 for advanced or metastatic breast and colorectal cancer

  This trial will try an oral medicine called PF-08032562, given alone or with other cancer drugs, in adults with advanced or metastatic breast or colorectal cancer.

  Recruiting at 13 sites Phase 1 Pfizer · Duarte, California and 16 other locations · NCT07318805

• Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative Breast Cancer

  This study tests an AI model using pre-treatment breast MRI to see if it can identify which locally advanced triple-negative breast cancer patients will benefit most from neoadjuvant chemotherapy.

  Recruiting Fujian Cancer Hospital · Fuzhou, Fujian and 4 other locations · NCT07880600

• JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners

  This phase 2 study tests JS212 alone or with JS207 or JS001 to see if it helps people with recurrent or metastatic triple-negative breast cancer.

  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality and 30 other locations · NCT07876557

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Oral paclitaxel in triple-negative breast cancer before main chemotherapy

  This trial tests whether giving an oral paclitaxel dose-6 in combination with standard epirubicin and cyclophosphamide can be tolerated in women with triple-negative breast cancer before surgery.

  Recruiting Phase 1/2 The Affiliated Hospital Of Guizhou Medical University · Guiyang, Guizhou · NCT07739485

• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

  Recruiting Fudan University · Shanghai · NCT07705438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.