Radiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01)

Rhea-AI Summary

Radiopharm Theranostics (ASX:RADX) announced dosing of the first patient in its First‑In‑Human Phase 1/2a trial of 177Lu‑BetaBart (RV‑01), the first radiotherapeutic from Radiopharm Ventures, a joint venture with MD Anderson.

The dose‑escalation and expansion study will evaluate safety, biodistribution, radiation dosimetry, preliminary anti‑tumor activity and determine a recommended dose. Preclinical studies showed tumor shrinkage and prolonged survival and support multiple solid‑tumor indications targeting the 4Ig isoform of B7‑H3.

Positive

• First patient dosed in FIH Phase 1/2a trial
• Agent developed by Radiopharm Ventures JV with MD Anderson
• Preclinical tumor shrinkage and prolonged survival reported
• Targeted design for the 4Ig isoform of B7‑H3 across multiple tumors

Negative

• No clinical efficacy data yet from human subjects
• Phase 1/2a dose‑escalation means safety and dose still undetermined

Key Figures

Trial phase: Phase 1/2a

1 metrics

Trial phase Phase 1/2a First‑in‑human dose escalation and expansion study of 177Lu‑Betabart (RV‑01)

Market Reality Check

Price: $4.96 Vol: Volume 18,478 is below th...

low vol

$4.96 Last Close

Volume Volume 18,478 is below the 20-day average of 49,979, suggesting limited pre‑news positioning. low

Technical Shares at $4.96 are trading slightly below the 200-day MA of $5.09 and about 69.48% under the 52-week high.

Peers on Argus

Biotech peers show mixed moves, with names like RENB up 19.33% and BRNS down 8.6...

1 Up 1 Down

Biotech peers show mixed moves, with names like RENB up 19.33% and BRNS down 8.65%. Momentum scanner peers TELO and BCAB are split (one up, one down), reinforcing a stock-specific context for this clinical update.

Previous Clinical trial Reports

5 past events · Latest: Dec 15 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	Interim Phase 2b data	Positive	+149.5%	RAD101 interim Phase 2b data showed 92% concordance with MRI.
Nov 18	Phase 1 approval	Positive	-4.8%	Approval to initiate Phase 1 therapeutic trial of RAD 402 in prostate cancer.
Nov 17	Enrollment milestone	Positive	+2.6%	RAD101 Phase 2b trial reached 50% enrollment with encouraging early imaging data.
Nov 12	Dose escalation update	Positive	+2.0%	DSMC cleared 177Lu‑RAD204 dose escalation to 90 mCi with favorable safety.
Oct 01	DSMC recommendation	Positive	+4.0%	Positive DSMC recommendation to accelerate 177Lu‑RAD202 Phase 1 dose escalation.

Pattern Detected

Clinical trial updates have usually led to positive price reactions, with one notable negative divergence on a trial-approval announcement.

Recent Company History

Over recent months Radiopharm has repeatedly advanced its clinical pipeline. Prior clinical trial updates on RAD101, RAD202, RAD204, and RAD402 between Oct 01 and Dec 15, 2025 generally produced positive moves, including a 149.53% reaction to interim RAD101 Phase 2b data. Today’s first‑patient dosing for 177Lu‑Betabart (RV‑01) fits this pattern of early‑stage radiopharmaceutical development progress across multiple solid‑tumor programs.

Historical Comparison

+30.7% avg move · In the past six months, RADX released five clinical‑trial updates with an average move of 30.67%, sh...

clinical trial

+30.7%

Average Historical Move clinical trial

In the past six months, RADX released five clinical‑trial updates with an average move of 30.67%, showing that trial news has often been a meaningful trading catalyst.

Clinical updates show progression from early Phase 1 dose escalation (RAD202, RAD204, RAD402) to Phase 2b imaging data for RAD101, and now first‑in‑human dosing for 177Lu‑Betabart (RV‑01) across diverse solid tumor targets.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-12-17

An effective Form F-3 dated Dec 17, 2025 registers the resale of up to 940,000 ADSs (representing 281,999,998 ordinary shares) by existing investors; Radiopharm only receives cash if associated options exercisable at A$0.039 are exercised.

Market Pulse Summary

This announcement marks first‑in‑human dosing in a Phase 1/2a trial of 177Lu‑Betabart (RV‑01), exten...

Analysis

This announcement marks first‑in‑human dosing in a Phase 1/2a trial of 177Lu‑Betabart (RV‑01), extending Radiopharm’s track record of advancing radiopharmaceutical candidates into the clinic. It follows prior positive safety and imaging signals from programs like RAD101, RAD202, and RAD204. Investors may monitor upcoming safety, biodistribution and early anti‑tumor data, while also noting the existing F‑3 resale registration and the generally modest historical volatility around some early‑stage trial initiations.

Key Terms

first-in-human, phase 1/2a, biodistribution, monoclonal antibody, +3 more

7 terms

first-in-human medical

"announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

phase 1/2a medical

"dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial"

Phase 1/2a is an early stage in testing new medicines or treatments, combining two steps into one process. It helps researchers quickly assess whether a treatment is safe and shows signs of working, while also gathering initial information on the best dosage. For investors, this stage indicates how close a potential new therapy is to becoming available and its initial safety profile.

biodistribution medical

"designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBart"

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.

monoclonal antibody medical

"177Lu-Betabart is a Lu177-tagged engineered monoclonal antibody, designed with a strong affinity"

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.

immune checkpoint medical

"B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types"

Immune checkpoints are molecules on immune cells that act like brakes, helping prevent the immune system from attacking healthy tissue. Drugs that block or modulate these checkpoints can release those brakes to boost the body’s ability to fight cancer or infections, but they can also increase the risk of immune side effects. Investors watch progress on checkpoint-targeting therapies because clinical trial results, approvals, and safety profiles strongly influence a drug’s commercial potential and company value.

radiopharmaceutical medical

"a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals"

A radiopharmaceutical is a special type of medicine that contains a small amount of radioactive material, used primarily for medical imaging or treatment. It can be thought of as a tiny, targeted signal that helps doctors see inside the body or deliver therapy directly to affected areas. For investors, understanding radiopharmaceuticals is important because they represent a growing field within healthcare, driven by advancements in diagnostics and personalized treatments.

b7-h3 medical

"strong affinity for the 4Ig isoform of B7-H3. B7-H3 is an immune checkpoint molecule"

B7‑H3 (CD276) is a protein that sits on the surface of certain cells, including many cancer cells, and can help tumors hide from the immune system—like a disguise that makes them harder for the body's defenses to spot. Investors watch B7‑H3 because medicines designed to block or use this protein aim to reveal tumors or deliver targeted therapy; progress in trials, regulatory clearances, or deals around B7‑H3 programs can materially change a biotech company's prospects and valuation.

AI-generated analysis. Not financial advice.

First radiotherapeutic agent developed by Radiopharm Ventures, the joint venture between Radiopharm Theranostics and MD Anderson Cancer Center 

Preclinical animal studies of BetaBart (RV-01) have demonstrated tumor shrinkage and prolonged survival

SYDNEY, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01).

The Phase 1/2a clinical trial is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBart, along with its preliminary anti-tumor activity. The trial will also determine the recommended dose of 177Lu-BetaBart for future studies. This agent was developed by Radiopharm Ventures, a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Center.

177Lu-Betabart is a Lu¹⁷⁷-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.

“Dosing of the first patient in the Phase 1/2a trial of 177Lu-BetaBart marks an important milestone for Radiopharm, as this is the first radiotherapeutic agent from our joint venture to enter the clinic,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “177Lu-BetaBart has the potential to become a highly differentiated radiotherapeutic for patients with aggressive advanced solid tumors, and we are grateful to our collaborators and participants in this Phase 1/2a trial.”

"We are honored to administer the first dose of 177Lu-BetaBart in this Phase 1/2a clinical trial,” noted Brandon Mancini, MD, MBA, FACRO, Medical Director at BAMF Health. “As a leading center for radiopharmaceutical therapeutic trials, we appreciate the opportunity to provide this novel, first-in-class radiotherapeutic for the treatment of a variety of advanced refractory solid tumors, while offering exceptional care to our clinical trial participants.”

In preclinical studies, 177Lu-BetaBart has shown evidence of efficacy and targeting of the specific 4Ig isoform of B7-H3, supporting its potential use in multiple indications, including prostate, pancreatic, breast and other solid tumors.

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 four Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.

Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.

For more information:
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

Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com

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

FAQ

What did Radiopharm Theranostics (RADX) announce on February 24, 2026 about BetaBart?

They announced dosing of the first patient in the Phase 1/2a trial of 177Lu‑BetaBart, marking the first radiotherapeutic from their JV to enter the clinic. According to the company, the study will assess safety, biodistribution, dosimetry and preliminary anti‑tumor activity.

What is the design and objective of the RADX Phase 1/2a 177Lu‑BetaBart trial?

The trial is a dose‑escalation and expansion study to evaluate safety, biodistribution and radiation dosimetry and to determine a recommended dose. According to the company, it will also collect preliminary anti‑tumor activity data in advanced solid tumors.

Who developed 177Lu‑BetaBart and what collaboration is involved with RADX?

177Lu‑BetaBart was developed by Radiopharm Ventures, a joint venture between Radiopharm and MD Anderson. According to the company, the JV brings preclinical expertise and clinical trial collaboration for this first‑in‑human program.

What does 177Lu‑BetaBart target and which cancers are being considered?

177Lu‑BetaBart is a Lu‑177 tagged engineered monoclonal antibody targeting the 4Ig isoform of B7‑H3. According to the company, preclinical work supports use in prostate, pancreatic, breast and other solid tumors.

What preclinical results support the 177Lu‑BetaBart clinical trial for RADX?

Preclinical animal studies showed evidence of tumor shrinkage and prolonged survival with 177Lu‑BetaBart. According to the company, these data supported advancing the agent into a first‑in‑human Phase 1/2a trial.

How will the Phase 1/2a RADX trial determine dosing and future plans for 177Lu‑BetaBart?

The dose‑escalation design will identify a recommended dose for future studies based on safety and dosimetry findings. According to the company, the expansion cohorts will further evaluate preliminary anti‑tumor activity at that dose.