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Radiopharm Theranostics Limited (AU:RAD)
ASX:RAD
177Lu-Betabart
Cervical Cancer, Ovarian Cancer, Colorectal Cancer, Castration-Resistant Prostate Cancer (Crpc), Endometrial Cancer, Esophageal Squamous Cell Carcinoma (Escc), Nsclc (Non-Small Cell Lung Cancer), Tnbc, Triple Negative Breast Cancer, Small Cell Lung Cancer (Sclc ), Head &Amp; Neck Squamous Cell Carcinoma (Hnscc)
Phase I/II
Not Yet Recruiting
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Sep 11, 2025
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177Lu-Rad202
Advanced Solid Tumors, Her2 Gene Mutation
Early Phase I
Recruiting
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
Feb 07, 2025
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Rad101 (18F-Fpia)
Brain Metastases From Solid Tumors
Phase II
Recruiting
Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases
Dec 19, 2024
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177Lu-Rad204
Non Small Cell Lung Cancer, Cutaneous Melanoma, Endometrial Cancer, Hnscc, Pdl1 Gene Mutation, Small Cell Lung Cancer ( Sclc ), Tnbc, Triple Negative Breast Cancer
Early Phase I
Recruiting
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
Feb 22, 2024
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Rad301 ([68Ga]-Rad301)
Healthy Volunteers, Pancreatic Ductal Adenocarcinoma
Phase I
Recruiting
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer
Mar 12, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Radiopharm Theranostics Limited (RAD) have in its pipeline
RAD is currently developing the following drugs: 177Lu-Betabart, 177Lu-Rad202, Rad101 (18F-Fpia). These drug candidates are in various stages of clinical development as the company works toward FDA approval.