Radiopharm Theranostics Doses First Patient in Second Cohort of Phase 1/2a Clinical Trial of BetaBart (RV-01) in B7-H3 Expressing Solid Tumors

Rhea-AI Summary

Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) reported dosing the first patient in the second cohort of its First‑In‑Human Phase 1/2a trial of RV‑01 (177Lu‑Betabart) at a 70 mCi dose in B7‑H3 expressing solid tumors. Advancement to this higher dose followed a positive recommendation from an independent Safety and Monitoring Committee.

RV‑01, the first therapeutic from Radiopharm’s joint venture with MD Anderson Cancer Center, is a 177Lutetium‑tagged monoclonal antibody targeting the 4Ig isoform of B7‑H3, an immune checkpoint overexpressed in several tumor types. The ongoing U.S. multi‑center study evaluates safety, biodistribution, radiation dosimetry, pharmacokinetics and preliminary anti‑tumor activity, and is planned to enroll up to 61 patients across multiple advanced solid cancers to determine a recommended dose for future studies.

Positive

• First patient dosed in second RV‑01 cohort at 70 mCi
• Independent Safety Committee supported escalation to 70 mCi dose
• Trial aims to enroll up to 61 advanced cancer patients
• Covers multiple B7‑H3 expressing solid tumors across 10+ cancer types
• RV‑01 is first therapeutic from MD Anderson joint venture
• Preclinical RV‑01 studies showed tumor shrinkage and prolonged survival in animals

Negative

• RV‑01 program remains in early First‑In‑Human Phase 1/2a stage
• No human efficacy or outcome data have been reported yet
• Dose escalation ongoing; recommended Phase 2 dose not yet established

Market reaction after Phase 1/2a clinical milestone: RADX -6.45% in the Aug 26 session

-6.45% 3.2x vol

5 alerts

-6.45% Session close to close

-11.5% Trough in 21 hr 45 min

$18.56M Market Cap

3.2x Rel. Volume

In the Aug 26 session, RADX declined 6.45%, reflecting a notable negative market reaction. Argus tracked a trough of -11.5% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. Trading volume was very high at 3.2x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.5% in the session following this news. -8.4% followed a prior tag-specific clinic...

Analysis

The stock moved -6.5% in the session following this news. -8.4% followed a prior tag-specific clinical-trial announcement in the platform history. The current RV-01 milestone likewise remained early-stage, with safety and dose selection still under evaluation. An effective F-3 resale registration was a sourced financing consideration; selling shareholders receive sale proceeds.

Key Figures

Dose: 70 mCi Trial participants: 61 eligible participants Isotope: 177Lu +1 more

4 metrics

Dose 70 mCi Second cohort of the Phase 1/2a RV-01 trial

Trial participants 61 eligible participants Planned enrollment for the Phase 1/2a study

Isotope 177Lu RV-01 radiopharmaceutical therapeutic

Trial identifier NCT07189871 FIH Phase 1/2a clinical trial

Previous Clinical trial Reports

5 past events · Latest: Aug 20 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 20	Clinical trial advance	Positive	-8.4%	Positive committee recommendation advanced RAD202 to Cohort 4 at 180mCi.
Aug 17	FDA trial planning	Positive	+4.3%	FDA meeting scheduled to align on pivotal Phase 3 RAD101 trial design.
Apr 20	Clinical trial findings	Positive	+4.6%	Initial RAD202 findings showed tumor uptake and no dose-limiting toxicities.
Apr 08	Clinical trial advance	Positive	+3.0%	Positive DSMC recommendation advanced RAD202 to Cohort 3 at 130mCi.
Mar 27	Clinical trial initiation	Positive	+0.0%	First patient dosed in Phase 1 RAD402 study for advanced prostate cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific clinical-trial reactions were mixed despite a positive 0.7% average move.

Key Terms

radiopharmaceutical therapeutic, monoclonal antibody, biodistribution, radiation dosimetry, +1 more

5 terms

radiopharmaceutical therapeutic medical

"RV-01, the first radiopharmaceutical therapeutic developed in Company’s joint venture"

A radiopharmaceutical therapeutic is a medicine that contains a radioactive atom attached to a molecule that delivers radiation directly to diseased cells, most often to treat cancers or other localized conditions. It works like a guided missile that carries a radiation payload to a biological target, so it matters to investors because development, manufacturing, regulatory approval, and safety requirements are specialized, costly, and can strongly affect a company’s commercial prospects.

monoclonal antibody medical

"RV-01 is a 177Lutetium-tagged engineered monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

biodistribution medical

"designed to evaluate the safety, biodistribution, radiation dosimetry"

Biodistribution is the map of where a drug, vaccine, or diagnostic agent travels and accumulates inside the body after administration. Investors care because where a product ends up affects how well it works, what side effects it may cause, and whether regulators will approve it—similar to tracking dye in a plumbing system to find leaks or blockages; unexpected destinations can raise safety, cost, and market-adoption risks.

radiation dosimetry medical

"biodistribution, radiation dosimetry and preliminary anti-tumor activity"

Radiation dosimetry is the measurement and calculation of the amount of ionizing radiation absorbed by people, biological tissues, or materials. It matters to investors because accurate dosimetry determines safety, regulatory approval, product labeling and liability, and the effectiveness of medical treatments or industrial processes—much like measuring how long you can safely stay in the sun to avoid a burn, it helps companies manage risk, costs, and marketability.

pharmacokinetics medical

"designed to establish the safety profile, biodistribution, pharmacokinetics"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Doses first patient at 70 mCi dose of RV-01, the first radiopharmaceutical therapeutic developed in Company’s joint venture with MD Anderson Cancer Center

SYDNEY, Aug. 26, 2026 (GLOBE NEWSWIRE) -- 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 it has dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing tumors. This follows a positive recommendation from the Safety and Monitoring Committee (SMC), an independent multidisciplinary committee, to advance to the 70 mCi dose of RV-01.

RV-01 is a 177Lutetium-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

The Phase 1/2a clinical trial is a dose escalation and expansion trial designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity of RV-01 in B7-H3 expressing tumors. The trial will determine the recommended dose of RV-01 to move forward in future studies. The Phase 1/2a study is currently being conducted at clinical centers across the U.S.

"Dosing the first patient in the second dose cohort of our Phase 1/2a RV-01 study marks an important clinical and operational milestone for Radiopharm and reflects the continued advancement of this first therapeutic radiopharmaceutical program from our joint venture with MD Anderson Cancer Center," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The recommendation to proceed to the 70 mCi dose level provides an important early indication of the program's progression through dose escalation and reinforces our confidence in RV-01's development pathway.”

“B7-H3 remains one of the most compelling targets in oncology due to its broad expression across multiple solid tumor types, and we believe RV-01 has the potential to emerge as a differentiated therapeutic approach for patients with significant unmet needs. We remain focused on enrolling patients in the current cohort and look forward to reporting initial clinical data later this year," commented Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.

About RV-01

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

About the Phase 1/2a Clinical Trial
The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-Betabart (RV-01). The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.

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:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm  
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

FAQ

What did Radiopharm Theranostics (RADX) announce about the RV-01 trial on August 26, 2026?

Radiopharm Theranostics announced it dosed the first patient in the second cohort of its RV‑01 Phase 1/2a trial at 70 mCi. According to Radiopharm, this followed an independent Safety and Monitoring Committee recommendation to advance dose escalation for B7‑H3 expressing solid tumors.

What is RV-01 (177Lu-Betabart) being developed by Radiopharm Theranostics (RADX)?

RV‑01 is a 177Lutetium-tagged monoclonal antibody therapeutic targeting the 4Ig isoform of B7‑H3 in solid tumors. According to Radiopharm, RV‑01 is the first radiopharmaceutical therapeutic from its MD Anderson joint venture and has shown tumor shrinkage and prolonged survival in multiple animal studies.

What is the design of the RV-01 Phase 1/2a clinical trial for Radiopharm Theranostics (RADX)?

The RV‑01 Phase 1/2a trial is a First‑In‑Human dose escalation and expansion study in B7‑H3 expressing tumors. According to Radiopharm, it assesses safety, biodistribution, pharmacokinetics and radiation dosimetry, and will determine the recommended RV‑01 dose for future clinical studies.

How many patients and which cancers are included in Radiopharm Theranostics’ (RADX) RV-01 trial NCT07189871?

The RV‑01 study aims to enroll 61 eligible participants with various advanced solid tumors expressing B7‑H3. According to Radiopharm, included cancers span prostate, colorectal, lung, head and neck, ovarian, cervical, endometrial, triple negative breast, and esophageal squamous cell carcinoma.

Why is B7-H3 an important target in Radiopharm Theranostics’ (RADX) RV-01 program?

B7‑H3 is considered important because it is an immune checkpoint molecule overexpressed in several solid tumor types. According to Radiopharm, this broad expression makes B7‑H3 a compelling target for antibody-based radiopharmaceutical therapies such as RV‑01 in patients with significant unmet medical needs.

What does dosing the first patient in the second cohort mean for RV-01’s development at Radiopharm Theranostics (RADX)?

Dosing the first patient in the second cohort marks progression of RV‑01’s dose escalation to 70 mCi. According to Radiopharm, it represents an important clinical and operational milestone and reflects ongoing advancement of the First‑In‑Human Phase 1/2a program in B7‑H3 expressing tumors.

Where is Radiopharm Theranostics (RADX) conducting the RV-01 Phase 1/2a clinical trial?

The RV‑01 Phase 1/2a trial is currently being conducted at clinical centers across the United States. According to Radiopharm, these sites are enrolling patients with B7‑H3 expressing advanced solid tumors as part of the First‑In‑Human dose escalation and expansion study.