Radiopharm Theranostics is redefining oncology care to empower people with cancer to live longer and fuller lives.
We are committed to developing first-in-class radiopharmaceuticals through our clinical trials. Clinical trials are the foundation for discovering new medications that can improve health outcomes.
They provide high-quality data to guide clinical practices and ensure that treatments are safe and effective.
Radiopharm Theranostics' clinical trials listed below are currently active and recruiting.
A full list of our clinical trials can be found at clinicaltrials.gov.
| Study ID | Title | Drug | Cancer Type | Intervention | Phase | Location | Status |
|---|---|---|---|---|---|---|---|
| NCT06305962 | 177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors | 177Lu-RAD204 | PD-L1+ solid tumors | Therapeutic | I | AUS | Active, recruiting |
| NCT06824155 | HEAT Trial (HER2 Antibody Therapy With Lutetium-177) | 177Lu-RAD202 | HER2+ solid tumors | Therapeutic | I | AUS | Active, recruiting |
| NCT06777433 | Phase 2b Imaging Study of RAD101 in Participants with Suspected Recurrent Brain Metastases | 18F-RAD101 | Suspected recurrent brain metastasis | Diagnostic | IIb | USA | Active, recruiting |
| NCT05799274 | Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer | 68Ga-RAD301 | Pancreatic cancer | Diagnostic | I | USA | Active, recruiting |
Radiopharm Theranostics’ products are investigational; the safety and effectiveness have not been established.
The investigational products are not approved for sale in any country, for any indication.
- Replacement: we continuously seek regulatory advice to allow for the substitution of animal studies with in vitro alternatives.
- Reduction: whenever possible, we use novel molecular imaging technology in our animal studies instead of conventional methods and this enables us to reduce the number of animals by 50 to 80%.
- Refinement: we seek to minimise distress to research animals and, as part of our commitment to Replacement, seek to replace the most distressing studies when possible.
- Responsibility: we proudly accept responsibility for animals in our studies and actively engage with our partner organisations conducting research on our behalf.”
Nano-mAbs Clinical Trials
HER-2 PHASE 1 BREAST IMAGING COMPLETE
Phase 1 imaging has been completed on 33 patients with Technetium-99m in Shanghai and Germany
- Non-invasive and demonstrated safety
- Accumulation / high uptake in target within 2 hours post injection
- Acceptable biodistribution and dosimetry (renal protection can be achieved by standard pre-injection of gelufusin/amino acids mixture)
- Shows clear intra and inter-tumoural heterogeneity of HER-2 expression
- Provide more accurate and informative information on HER-2 cancers in comparison to existing IHC / FISH detections from biopsy samples
- Potential to be used for whole body assessment and treatment of HER-2+ cancers with different medical radioisotopes
HER-2 PHASE 1 BREAST THERAPEUTIC COMMENCING
- Phase 1 therapeutic about to launch in late stage HER-2+ breast cancer in Germany with Re-188 and Lu-177
- Can be easily adopted as a therapeutic with Lu-177 or Ac-225
- High probability of success as a therapeutic agent
- Patient safety data
- Same targeting as imaging but just change of war-head ( Tc-99m to Re-188, or Ga-68 to Lu-177 )
- Re- and Tc- structural and reaction chemistry is the “same” – easy conversion
- Apply to patients with good images and dosimetry – see then treat
PD-L1 PHASE 1 NON SMALL CELL LUNG CANCER IMAGING HAS BEEN COMPLETED ON 40 PATIENTS
- PD-L1 is a pan-cancer biomarker and immuno-checkpoint blockers are becoming the most important treatment of multiple cancers
- Imaging technology is licensed to Lantheus for research collaborations in diagnostic imaging
- Worldwide exclusive license to Radioharm Theranostics for therapeutic use
- Imaging done on 40 NSCLC patients in Shanghai General and at Kings College London
- Approved for Phase 2 Imaging Clinical Trial by MHRA
- DMF for Imaging filed with FDA in US
- Easily adopted for therapeutic use
- High probability of success as therapeutic agent
- Patients safety data; same cold kit as imaging but just change of war-head
- Apply to patients with good images – see then treat
Pivalate Clinical Trials
Pivalate Phase 1
Imaging complete in cerebral metastases, glioma, kidney, solid tumors
Pivalate Phase 2
In cerebral metastases, glioma interim positive data summary below
AVβ6 Integrin Clinical Trials
AVβ6 BEST-IN-CLASS : PHASE 1a COMMENCED
Biodistribution generally (Healthy subject comparison)
*None of Radiopharm Theranositcs’ product pipeline has received marketing authorization in any jurisdiction. Any use of Radiopharm Theranostic products is on an investigational basis or for use in approved clinical trials.
Key Publications
Discover our published research and conference abstracts, showcasing our contributions to the field of radiopharmacy and targeted radionuclide therapy.
Stay informed about our scientific findings and progress.
[99mTc]‑labelled anti‑Programmed Death‑Ligand 1 single‑domain antibody SPECT/CT:
a novel imaging biomarker for myocardial PD‑L1 expression.
Nzair et al., EJNMMI Research (2023) 13:44.
Early Phase I Study of a 99mTc-Labeled Anti–Programmed Death Ligand-1 (PD-L1) Single-Domain Antibody in SPECT/CT Assessment of PD-L1 Expression in Non–Small Cell Lung Cancer.
Xing et al., J Nucl Med 2019; 60:1213–1220.
Inter‑rater and intra‑rater agreement of [99mTc]‑labelled NM‑01, a single‑domain programmed death‑ligand 1 (PD‑L1) antibody, using quantitative SPECT/CT in non‑small cell lung cancer.
Hughes et al., EJNMMI Research (2023) 13:51.
British Journal of Cancer (2025) 132:913–921
a non-randomized, non-blinded clinical trial. Zhao et al., Breast Cancer Research (2024) 26:40.
99mTc‑labeled single‑domain antibody for SPECT/CT assessment of HER2 expression in diverse cancer types.
Altunay et al., European Journal of Nuclear Medicine and Molecular Imaging (2023) 50:1005–1013.
Development of a 99mTc-Labeled Single-Domain Antibody for SPECT/CT Assessment of HER2 Expression in Breast Cancer.
Zhao et al., Molecular Pharmaceutics 2021 18 (9), 3616-3622.
A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport.
Islam et al., Eur J Nucl Med Mol Imaging 52, 2290–2306 (2025)
Feasibility of [18F]fluoropivalate hybrid PET/MRI for imaging lower and higher grade glioma:
a prospective first‑in‑patient pilot study.
Islam et al., Eur J Nucl Med Mol Imaging 50, 3982–3995 (2023).
Clinical translation of 18F-fluoropivalate – a PET tracer for imaging short-chain fatty acid metabolism:
safety, biodistribution, and dosimetry in fed and fasted healthy volunteers.
Dubash et al., European Journal of Nuclear Medicine and Molecular Imaging (2020) 47:2549–2561.
Preclinical Evaluation of 3-18F-Fluoro-2,2-Dimethylpropionic Acid as an Imaging Agent for Tumor Detection.
Witney et al., J Nucl Med. 2014 Sep;55(9):1506-12
Superiority of 68Ga-Trivehexin PET/CT Over 18F-FDG PET/CT in the Evaluation of Lymph Nodes in Patients With Breast Cancer.
Komek et al., Clin. Nucl. Med. 2025 Mar 1;50(3):e175-e177.
incidental detection of a brain metastasis. Rehm et al., European Journal of Nuclear Medicine and Molecular Imaging (2024) 51:3469–3471.
αvβ6-integrin targeted PET/CT imaging in pancreatic cancer patients using 68Ga-Trivehexin.
Rehm et al., Front. Nucl. Med. Nov 2024, 4:1487602.
Potential Efficacy of 68Ga-Trivehexin PET/CT and Immunohistochemical Validation of αvβ6 Integrin Expression in Patients With Head and Neck Squamous Cell Carcinoma and Pancreatic Ductal Adenocarcinoma.
Das et al., Clin Nucl Med 2024;49: 733–740.
“Cancer Integrin” αvβ6 Imaging With 68Ga-Trivehexin PET/CT in Assessment of Ovarian Carcinoma.
Singh et al., Clin Nucl Med 2024;49: e619–e621
Validation of In-House Kit-Like Synthesis of 68Ga-Trivehexin and Its Biodistribution for Targeting the Integrin avb6 Expressing Tumors.
Thakral et al., Cancer Biother Radiopharm 2023 Sep;38(7):468-474.
PET/CT imaging of head‑and‑neck and pancreatic cancer in humans by targeting the “Cancer Integrin” αvβ6 with Ga‑68‑Trivehexin.
Quigley et al., Eur J Nucl Med Mol Imaging 49, 1136–1147 (2022).
Anti-Cancer Immune Priming with Beta-Radioligand Therapy and Isoform-Selective Targeting of 4Ig-B7-H3.
Glazer et al., BioRxiv 22 December 2024.
Dimerization of the 4Ig isoform of B7-H3 in tumor cells mediates enhanced proliferation and tumorigenic signaling.
Sutton et al., Commun Biol 7, 21 (2024).
Humanization, Radiolabeling and Biodistribution Studies of an IgG1-Type Antibody Targeting Uncomplexed PSA for Theranostic Applications.
Strand et al., Pharmaceuticals (Basel) 2021 Dec 1;14(12):1251.
PSA-targeted Alpha-, Beta- and Positron Emitting Immuno-Theranostics in Murine Prostate Cancer Models and Non-Human Primates.
Veach et al., Clin Cancer Res. 2021 April 01; 27(7): 2050–2060.
Imaging androgen receptor signaling with a radiotracer targeting free prostate specific antigen.
Ulmert et al., Cancer Discov. 2012 April ; 2(4): 320–327.
Expanded Access
Expanded access, also called compassionate use, refers to a pathway in which individuals with serious or immediately life-threatening diseases may gain access to an investigational therapy outside of clinical trials, when no comparable or satisfactory alternative therapy options are available.
Radiopharm Theranostics believes that participation in ongoing clinical trials of our investigational agents is the most appropriate way to access investigational products. Information on all ongoing investigational trials sponsored by Radiopharm Theranostics can be found at clinicaltrials.gov.
We recognize that not all individuals with cancer will be eligible for clinical trials or participation may not be feasible. However, at this time, Radiopharm Theranostics is not making investigational products available on an Expanded Access basis. Radiopharm Theranostics may revise this expanded access policy in the future.
Resources
This website may contain general information relating to various medical conditions and their treatment. Such information is provided for informational purposes only and is not meant to be a substitute for advice provided by a doctor or other qualified healthcare professional. People with cancer and/or caregivers should not use the information contained herein for diagnosing a health problem or disease. People with cancer and/or caregivers should always consult with a doctor or other healthcare professional for medical advice or information about diagnosis and treatment.
The links below to third-party websites (external sites not operated by RAD) are provided solely for your convenience. RAD does not control the opinions, claims or comments contained on any third-party website and your activities on those websites will be governed by the policies and practices of those third parties, including but not limited to privacy policies, cookies and tracking technologies. Any opinions or advice expressed in the content is solely that of the author and does not necessarily reflect the views RAD. RAD is not responsible for the accuracy, legality, or content of the external site or for that of subsequent links.
Patient Advocacy Groups (PAGs)
PAGs are non-profit groups that represent the interests of people with cancer and their families in healthcare systems, policymaking, research, and education. PAGs play a vital role in improving the healthcare experience and outcomes for people with cancer by bridging the gap between the medical community, policymakers, and the people directly affected by illness. PAGs can provide emotional support, counseling, and education, as well as practical tools like current guides on treatment options.
At Radiopharm Theranostics, we understand the importance of emotional support, education, and advocacy. The following PAGs may serve as valuable resources for more information:
For people with Pancreatic Cancer: https://pancan.org/
For people with Brain Metastasis: https://www.abta.org/
