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Ga-HA-DOTATATE

Phase 1

Neuroendocrine Tumors | Small molecule | Oncology |Avalon GloboCare Corp.|Last Updated: May 14, 2025

Target and mechanism

ModalitySmall molecule

Also known as [68]Ga-HA-DOTATATE

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,534

FDA Designations

No designations recorded

Clinical trial landscape

Ga-HA-DOTATATE · 1 trial · 1 indication

Phase 1 1
NCT03145857A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to UseNeuroendocrine Tumors
RECRUITING1,534 Analytics
PHASE1RECRUITING
A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
Neuroendocrine Tumors
NCT031458571,534
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Study Endpoints

Primary Endpoints

Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)

Vital signs are measured before first injection of \[68\]Ga-HA-DOTATATE and after \[68\]Ga-HA-DOTATATE scan and changes will be summarized.

Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)

A blood sample is drawn before first injection of \[68\]Ga-HA-DOTATATE and after \[68\]Ga-HA-DOTATATE scan. The haematology and biochemistry parameters will be recorded and all changes will be summarized.

Number of participants with adverse events within 24 hours (safety sub-group)
Within 24 hours of [68]Ga-HA-DOTATATE scan completion

Participants will be evaluated for AE occurrence once the \[68\]Ga-HA-DOTATATE has been administered for AEs occuring within 24 h of first scan.

Number of participants with adverse events
Up to 2 hours after [68]Ga-HA-DOTATATE administration

Participants will be evaluated for AE occurrence once the \[68\]Ga-HA-DOTATATE has been administered for AEs occuring while in the Nuclear Medicine Department.

Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT
Up to 6 years

\[68\]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of \[68\]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for up to 5 lesions and compared to results of baseline standard of care CT for presence/absence of each lesion. An overall assessment of the correlation between \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI and baseline CT will be made.

Secondary Endpoints

Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan
Up to 6 years
Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care MRI
Up to 6 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[68]Ga-HA-DOTATATEEXPERIMENTALAll participants will be imaged with \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven \[68\]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.

Interventions

NameTypeDescription
[68]Ga-HA-DOTATATEDRUGAll participants will be injected with \[68\]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
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Eligibility Criteria

Age Range14 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT obtained within 6 months of enrolment is required. A sta...

Countries:Canada
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Frequently asked questions about Ga-HA-DOTATATE

What is Ga-HA-DOTATATE used for in neuroendocrine tumors?

Ga-HA-DOTATATE is an investigational small molecule being studied for use in neuroendocrine tumors. It is a diagnostic agent designed to identify or diagnose tumors that have somatostatin receptors. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does Ga-HA-DOTATATE target?

Ga-HA-DOTATATE targets somatostatin receptors, which are found on certain tumors, including neuroendocrine tumors. By binding to these receptors, the drug is intended to help identify or diagnose such tumors through imaging. This mechanism is being evaluated in an ongoing Phase 1 clinical trial.

Who makes Ga-HA-DOTATATE?

Ga-HA-DOTATATE is being developed by Avalon GloboCare Corp., a biopharmaceutical company listed on the stock exchange under the ticker symbol ALBT. The company is conducting clinical research on this investigational agent for use in neuroendocrine tumors.

What phase is Ga-HA-DOTATATE in?

Ga-HA-DOTATATE is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is currently being studied in an active clinical trial to evaluate its safety and its ability to identify tumors with somatostatin receptors.

What clinical trials is Ga-HA-DOTATATE in?

Ga-HA-DOTATATE is being evaluated in one active Phase 1 clinical trial with the identifier NCT03145857. This study is recruiting participants in Canada and aims to assess the safety and diagnostic capability of the drug in identifying tumors with somatostatin receptors. The trial is uncontrolled and not blinded, with an enrollment target of 1,534 participants aged 14 years and older.

Is Ga-HA-DOTATATE the same as [68]Ga-HA-DOTATATE?

Yes, Ga-HA-DOTATATE is also known as [68]Ga-HA-DOTATATE. The alternative name reflects the radioactive isotope gallium-68 attached to the molecule, which is used for imaging purposes. Both names refer to the same investigational drug being developed by Avalon GloboCare Corp.