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Also known as [68Ga]Ga-NeoB
Ga-NeoB · 2 trials · 1 indication
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB and capecitabine. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.
The distribution of adverse events for 177-Lu-NeoB in combination with capecitabine will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Dose modifications (dose interruptions, dose discontinuations and reductions) for \[177Lu\]Lu-NeoB in combination with capecitabine will be assessed and summarized using descriptive statistics.
Objective Response Rate (ORR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as per local review and according to RECIST 1.1.
Clinical Benefit Rate (CBR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or maintaining an overall response of Stable Disease (SD) for at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1.
Time to response is the time from the date of randomization to the first documented response (Complete Response (CR) or Partial Response (PR), which must be confirmed subsequently) as per local review and according to RECIST 1.1.
Duration of Overall Response (DoR) applies only to participants whose best overall response is confirmed CR or confirmed PR according to RECIST 1.1. The start date is the date of first documented confirmed response (CR or PR) and the end date is the date defined as first documented progression or death due to underlying cancer.
Progression Free Survival (PFS) is defined as the time from the date of first dose of \[177Lu\]Lu-NeoB to the date of confirmed progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1.
Overall Survival (OS) is defined as the time from date of first dose of \[177Lu\]Lu-NeoB to date of death due to any cause.
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB, ribociclib and fulvestrant with or without goserelin. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Dose interruptions, discontinuation and dose reductions will be assessed for tolerability.
| Arm | Type | Description |
|---|---|---|
| Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabine | EXPERIMENTAL | \[177Lu\]Lu-NeoB 150mCi q6w + Capecitabine 1000mg/ m2 BID Day1-14 in a 21-day schedule |
| Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabine | EXPERIMENTAL | \[177Lu\]Lu-NeoB 100mCi q3w+ Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule |
| Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabine | EXPERIMENTAL | \[177Lu\]Lu-NeoB 200mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule |
| Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabine | EXPERIMENTAL | \[177Lu\]Lu-NeoB 100mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule |
| Arm 1 | EXPERIMENTAL | Participants will receive \[177Lu\]Lu- NeoB in combination with ribociclib and fulvestrant, in the dose escalation and the backfill parts of the study. Goserelin administration is only applicable for pre/peri-menopausal women and men. |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-NeoB | DRUG | 68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions. |
| [177Lu]Lu-NeoB | DRUG | \[177Lu\]Lu-NeoB is a radioligand therapy drug. |
| Capecitabine | DRUG | Capecitabine is a chemotherapy drug. |
| Ribociclib | DRUG | 600 mg once daily (OD) days 1 to 21 every 28 days |
| Fulvestrant | DRUG | 500 mg at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and every 28 days thereafter |
| Goserelin | OTHER | For pre/peri-menopausal women and men only. |
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Participant is female or male adult ≥ 18 years old at the time of informed consent(s). 3. Participant has a histologically and/or cytologically documented diagnosis of ER+ breast cancer (ER expre...
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Ga-NeoB is an investigational small molecule radiopharmaceutical being developed by Novartis AG (ticker NVS) for breast cancer. It is in Phase 1 clinical development and is being studied in patients with GRPR-positive, ER-positive, HER2-negative advanced or metastatic breast cancer. It is not an approved therapy.
Ga-NeoB is being studied in breast cancer, specifically in patients with GRPR-positive, ER-positive, HER2-negative advanced or metastatic disease. The trials enroll adults whose cancer has progressed after prior endocrine therapy combined with a CDK4/6 inhibitor. Ga-NeoB remains investigational and has not been approved for any use.
Novartis AG, which trades under the ticker NVS, is the developer of Ga-NeoB. The company is running the clinical program for this investigational radiopharmaceutical in breast cancer, including studies that pair it with other agents such as capecitabine, ribociclib, and fulvestrant.
Ga-NeoB is in Phase 1 clinical development. Two Phase 1 trials are listed, both currently active and not recruiting, with a combined enrollment of 48 patients. No trials have been completed, and Ga-NeoB has not been approved by the FDA or any other regulator.
Ga-NeoB is being evaluated in two Phase 1 trials. NCT06247995 studies it with capecitabine in GRPR-positive, ER-positive, HER2-negative metastatic breast cancer across the United States, Australia, Canada, China, France, Germany, the Netherlands, Portugal, Singapore, South Korea, and Spain. NCT05870579 studies it with ribociclib and fulvestrant in ER-positive, HER2-negative, GRPR-positive advanced breast cancer.
Yes, Ga-NeoB and [68Ga]Ga-NeoB refer to the same investigational agent. [68Ga]Ga-NeoB is an alternative name used for this Novartis radiopharmaceutical in its Phase 1 breast cancer program, so readers searching either name are looking at the same drug candidate.