Full Press Release Details
Radiopharm Theranostics Presents Initial Findings
from Phase 1 First-in-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026
177Lu-RAD202 demonstrated encouraging tumor
uptake and a favorable safety profile in the lowest dose cohort
Data Safety and Monitoring Committee Recently
Approved Advancing 177Lu-RAD202 to Next Highest Dose at 130 mCi
Sydney, Australia - 20 April 2026 - Radiopharm Theranostics
(ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on
developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that new data from the ongoing
Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented
as a poster at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17-22, 2026 in San Diego,
"These first-in-human results represent an important early milestone
for our HER2-targeted radiopharmaceutical program," said Dr. Dimitris Voliotis, Chief Medical Officer of Radiopharm Theranostics.
"In a heavily pre-treated patient population with significant unmet need, 177Lu-RAD202 demonstrated encouraging tumor uptake and
a favorable safety profile at the lowest dose level. Importantly, the observed dosimetry supports continued dose escalation, which was
recently approved by the Data Safety and Monitoring Committee (DSMC) to advance to the third cohort at 130 mCi dosing. We look forward
to further evaluating the therapeutic potential of this novel approach and expect to see signs of antitumor activity at higher, more therapeutic
The AACR poster highlights first-in-human safety, biodistribution,
dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast
and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi.
Key Findings from the AACR Abstract and Poster
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Poster Presentation Details
The complete poster can be found on the Company's website
On April 8, 2026, Radiopharm Theranostics announced
the positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance 177Lu-RAD202 to the third cohort at a dose
level of 130mCi in the Phase 1 HEAT' clinical trial in patients with HER2-positive advanced solid tumors1. The
DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations
regarding trial continuation.
About the HEAT Trial
177Lu-RAD202 is a Lutetium-177-labeled single-domain antibody
(sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the
beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density.
The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155)
is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced
or metastatic solid tumors.
RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that
targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast
cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive
breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution2,3.
| 1 | clinicaltrials.gov/study/NCT06824155 |
| 2 | Zhao et al, Br Canc Res (2024) |
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company
developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high
unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated
platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one
Phase 2 and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm
Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (formerly Stern IR)
Follow Radiopharm Theranostics:
Website - https://radiopharmtheranostics.com/
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Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia