Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 20 of 92 competitors
Ga-NeoB is an investigational small molecule being studied for use in breast cancer. It is a diagnostic imaging agent that targets gastrin-releasing peptide receptors (GRPR), which are expressed in certain breast cancers. Ga-NeoB is being evaluated in clinical trials to help identify patients with GRPR-positive tumors who may benefit from treatment with the therapeutic agent [177Lu]Lu-NeoB.
Ga-NeoB targets the gastrin-releasing peptide receptor (GRPR), a cell surface receptor that is overexpressed in some breast cancers. By binding to GRPR, Ga-NeoB allows for imaging of GRPR-positive tumors. This targeting is used to select patients for treatment with the related therapeutic agent [177Lu]Lu-NeoB, which delivers radiation to GRPR-expressing cancer cells.
Ga-NeoB is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate Ga-NeoB as a diagnostic agent in combination with the therapeutic radiopharmaceutical [177Lu]Lu-NeoB for the treatment of breast cancer.
Ga-NeoB is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The ongoing Phase 1 trials are evaluating the safety and dosing of [177Lu]Lu-NeoB, which uses Ga-NeoB for patient selection, in combination with other cancer therapies for advanced breast cancer.
Ga-NeoB is being studied in two active Phase 1 clinical trials. NCT05870579 evaluates [177Lu]Lu-NeoB with ribociclib and fulvestrant in ER+, HER2-, GRPR+ advanced breast cancer. NCT06247995 evaluates [177Lu]Lu-NeoB with capecitabine in GRPR+, ER+, HER2- metastatic breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor.
Yes, Ga-NeoB is also known as [68Ga]Ga-NeoB. The name [68Ga]Ga-NeoB specifies that the molecule is labeled with the radioactive isotope gallium-68, which enables positron emission tomography (PET) imaging. Ga-NeoB is the shorthand name for this radiopharmaceutical used in clinical trials for breast cancer imaging.