Radiopharm advances RV-01 to second dose cohort in first-in-human cancer trial
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) has dosed the first patient in the second cohort of its Phase 1/2a first-in-human trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing solid tumours. The step follows a positive recommendation from the independent Safety and Monitoring Committee (SMC) to advance to the 70 mCi dose level.
RV-01 is described as the first radiopharmaceutical therapeutic developed through the company’s joint venture with MD Anderson Cancer Center. The announcement was made on 26 August 2026.
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What the dose escalation milestone signals
The SMC’s recommendation to advance dosing provides an early indication that the programme is progressing through dose escalation with an acceptable safety profile so far. For investors, this represents a de-risking step along the clinical pathway and momentum toward establishing the recommended dose for future studies.
The current second-cohort milestone builds directly on the programme’s February 2026 origin point, when the first patient dosed in Cohort 1 initiated the first-in-human evaluation of 177Lu-Betabart and formally validated the MD Anderson joint venture’s therapeutic development platform.
The Phase 1/2a study is a dose escalation and expansion trial designed to evaluate several key parameters:
- Safety profile
- Biodistribution
- Pharmacokinetics
- Radiation dosimetry
- Preliminary anti-tumour activity
The trial’s ultimate purpose is to determine the recommended dose of RV-01 to move forward in future studies.
CEO Commentary
“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.”
Understanding B7-H3 and radiopharmaceutical therapy
B7-H3 is an immune checkpoint molecule, a type of protein involved in regulating the body’s immune response, that is overexpressed across several solid tumour types. This broad expression has made it a compelling target for antibody-based cancer immunotherapy.
RV-01 is a 177Lutetium-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. In plain terms, it is engineered to seek out tumour cells carrying this target and deliver radiation directly to them.
Multiple preclinical studies with RV-01 have shown tumour shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. These results are from animal studies only and have not yet been demonstrated in humans.
For investors, B7-H3’s expression across many tumour types points to a potentially large addressable opportunity if the approach is validated in clinical settings. Targeted radiopharmaceuticals are viewed as an attractive oncology approach because they aim to concentrate radiation at the tumour while limiting exposure to healthy tissue.
| Attribute | Detail |
|---|---|
| Drug | RV-01 (177Lu-Betabart) |
| Type | 177Lu-conjugated monoclonal antibody |
| Target | 4Ig isoform of B7-H3 |
| Origin | Radiopharm Ventures JV with MD Anderson |
| Trial phase | Phase 1/2a (dose escalation & expansion) |
Inside the Phase 1/2a trial design
The first-in-human Phase 1/2a study (NCT07189871) is a dose escalation and expansion trial currently being conducted at clinical centres across the U.S. It is designed to establish the safety profile, biodistribution, pharmacokinetics and radiation dosimetry of RV-01, with a target enrolment of 61 eligible participants.
Participants must have a documented history of histopathologically confirmed cancer across a broad range of tumour types:
- 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
- Esophageal squamous cell carcinoma
The breadth of tumour types being enrolled reflects the wide potential application of the B7-H3 target across multiple solid cancers.
What comes next for RV-01 and Radiopharm
Management expects to report initial clinical data later this year (2026), which stands as a key upcoming catalyst for investors. In the meantime, the company remains focused on enrolling patients in the current cohort.
RAD204 partial response data, published in July 2026, offered investors a preview of what early efficacy signals from a Radiopharm Phase 1 programme can look like, with a RECIST-confirmed tumour reduction of up to 43% at the 90 mCi dose level and no dose-limiting toxicities across any cohort.
The programme sits within a broader clinical-stage pipeline that includes one Phase 2 and five Phase 1 trials across lung, breast, prostate and brain cancers. Radiopharm maintains a dual listing on the ASX (RAD) and Nasdaq (RADX).
CMO Commentary
“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.
RV-01 positions itself as a differentiated, MD Anderson-backed programme within a diversified clinical-stage radiopharmaceutical portfolio, with a data catalyst anticipated on the near horizon. As with all early-stage clinical programmes, progression remains subject to trial outcomes and regulatory processes.
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