67Cu-SAR-bisPSMA / Clarity Pharma - LARVOL DELTA

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer (SNMMI 2025) - P1/2 | "A recent protocol amendment increased the number of participants from 14 to 24 in the Cohort Expansion phase, in which 8 will receive combination therapy of 67Cu-SAR-bisPSMA with enzalutamide... N/A"

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • FOLH1

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer (SNMMI 2025) - P1/2 | "A recent protocol amendment increased the number of participants from 14 to 24 in the Cohort Expansion phase, in which 8 will receive combination therapy of 67Cu-SAR-bisPSMA with enzalutamide... N/A"

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • FOLH1

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer. (ASCO 2025) - P1/2 | "A recent protocol amendment increased the number of participants from 14 to 24 in the Cohort Expansion phase, in which 8 will receive combination therapy of 67Cu-SAR-bisPSMA with enzalutamide...Response to 67Cu-SAR-bisPSMA will be assessed biochemically (≥50% decline in prostate-specific antigen) and radiographically (by RECIST V1.1 and PCWG3). ClinicalTrials.gov Identifier: NCT04868604."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

First patient imaged in Phase III AMPLIFY trial with Cu-64 SAR-bisPSMA PET/CT (Clarity Pharmaceuticals Press Release) - "Clarity Pharmaceuticals...is pleased to announce that it has imaged the first patient in its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence (BCR) of prostate cancer, AMPLIFY (NCT06970847), at XCancer in Omaha, Nebraska (NE)."

Trial status • Prostate Cancer

SECuRE trial update: First patient treated in the Phase II Cohort Expansion (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce the treatment of the first participant with their first dose of 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604)....This follows the recent recommendation by the Safety Review Committee (SRC) after the successful completion of the Dose Escalation Phase to commence enrollment for the Cohort Expansion Phase at the 8 GBq dose level, with an increase of the number of cycles from up to 4 to up to 6. This participant will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), as per the recent protocol amendment to include a subset of participants in the Cohort Expansion Phase to receive this combination."

Trial status • Castration-Resistant Prostate Cancer

SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. (PRNewswire) - P1/2 | N=44 | SECuRE (NCT04868604) | Sponsor: Clarity Pharmaceuticals Ltd | "Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study; Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC confirmed expansion at 8 GBq dose level and recommended to increase the number of cycles from up to 4 to up to 6; Cohort 4 of the Dose Escalation Phase of the SECuRE trial, assessing multiple administrations of 67Cu-SAR-bisPSMA, is complete. Prostate-specific antigen (PSA) levels are continuing to drop in 3 participants, with reductions ≥80% observed in 3 cases so far. A complete response was achieved in a participant in cohort 4 following 2 doses of 12 GBq of 67Cu-SAR-bisPSMA to date, based on the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST)."

DSMB • P1/2 data • Trial status • Castration-Resistant Prostate Cancer

Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI)....The data for this FTD submission was based on the preliminary results to date from the Phase I/IIa SECuRE study."

Evidence highlight • Fast track • Metastatic Castration-Resistant Prostate Cancer • PSMA1 • PSMA2

EAP: Multiple doses of 67Cu-SAR-bisPSMA (Clarity Pharmaceuticals Press Release) - P=NA | N=NA | "Complete response with 2 doses of 8GBq of 67Cu-SAR-bisPSMA....The patient’s latest follow up on 14 October 2024 showed that he remains with undetectable PSA for almost 13 months, having received his first dose of 67Cu-SAR-bisPSMA over 17 months ago (June 2023). Most AEs related to 67Cu-SAR-bisPSMA were mild to moderate, with the majority having either improved or resolved over time. Durable response with multiple doses of 67Cu-SAR-bisPSMA....A reduction greater than 50% in PSA levels was observed in this patient following the first administration of 67Cu-SAR-bisPSMA and a drop of 94% in PSA was observed after the fourth cycle."

Clinical data • Metastatic Castration-Resistant Prostate Cancer

Cohort 4 – SECuRE Trial (Clarity Pharmaceuticals Press Release) - P1/2a | N=44 | SECuRE (NCT04868604) | Sponsor: Clarity Pharmaceuticals Ltd | "The SRC has completed the review of the safety data of the third participant in cohort 4 who received 2 doses of 67Cu-SAR-bisPSMA. The safety profile of multiple doses of 12GBq of 67Cu-SAR-bisPSMA remains favourable, confirming the preliminary safety findings of previous cohorts (single-dose cohorts, 1, 2 and 3). Almost all AEs in the 3 participants in cohort 4 were mild to moderate, with the majority having resolved or improved at the last assessment. No DLTs have been observed in any participants across all cohorts in the SECuRE trial to date....Early preliminary efficacy assessment showed a reduction in PSA levels following 2 treatment cycles in all 3 participants in cohort 4, with 2 patients already showing PSA reductions >50% vs. baseline. The last patient’s PSA peaked at 32.7 ng/mL and has so far dropped to 20.2 ng/mL."

P1/2 data • Castration-Resistant Prostate Cancer

Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce it will be commencing a pivotal Phase III trial of its ⁶⁴Cu-SAR-bisPSMA diagnostic in patients with BCR of prostate cancer following a successful end of phase meeting with the U.S. FDA. The trial, named AMPLIFY...is expected to begin patient recruitment in early 2025....The AMPLIFY trial will be a non-randomised, single-arm, open-label, multi-centre, Phase III diagnostic clinical trial of ⁶⁴Cu-SAR-bisPSMA Positron Emission Tomography (PET) in approximately 220 participants with rising or detectable PSA after initial definitive treatment. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of ⁶⁴Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer."

FDA event • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment of metastatic castrate-resistant prostate cancer patient with two cycles of 67Cu-SAR-bisPSMA (8 GBq) leads to complete response (RECIST) and undetectable PSA level: A case report (EANM 2024) - P1/2 | "The patient had evidence of metastatic disease in 2022 and underwent several lines of systemic therapies including abiraterone, enzalutamide and a clinical trial (PARP inhibitor)... This case shows for the first time the anti-tumour effect of two doses of 67Cu-SAR-bisPSMA in a patient with mCRPC leading to a CR and undetectable PSA level. 67Cu-SAR-bisPSMA had a manageable safety profile and may represent an effective option for the treatment of patients with mCRPC."

Case report • Clinical • Metastases • Anemia • Fatigue • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia • Xerostomia

SECuRE trial advances: No dose limiting toxicities and strong preliminary efficacy data in first multi-dose cohort (PRNewswire) - P1/2a | N=44 | SECuRE (NCT04868604) | Sponsor: Clarity Pharmaceuticals Ltd | "Clarity...is pleased to announce an update on the safety review of the first 3 participants enrolled in cohort 4 of the SECuRE trial who received 2 doses of ⁶⁷Cu-SAR-bisPSMA. Cohort 4 is the final cohort in the dose escalation phase of the study, with participants receiving a minimum of 2 and a maximum of 4 doses of ⁶⁷Cu-SAR-bisPSMA at 12GBq...The SRC has reviewed the safety data of the first 3 participants of cohort 4 who have received 2 cycles of 67Cu-SAR-bisPSMA, and no DLTs have been observed to date. Two participants have completed the DLT period, and 1 participant will complete the DLT period by the end of September...In the weeks following the last therapy dose, these participants have already exhibited PSA drops of more than 60%...With a number of Clarity's recent developments...Dr Alan Taylor, will host a webcast and conference....on Wednesday 18 September at 10.30am AEST."

P1/2 data • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ⁶⁴Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy...Clarity's ongoing clinical program with ⁶⁴Cu-SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease. The completed Phase I PROPELLER study....Clarity commenced a registrational Phase III trial in this patient population, CLARIFY, where recruitment is ongoing. In parallel, the Phase I/II trial, COBRA was found to be safe..."

Fast track • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer (SNMMI 2024) - P1/2 | "Not applicable. Poster Award Candidate: Poster Award Candidate"

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67 Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer. (ASCO 2024) - P1/2 | "In the United States, 4 sites are active with additional sites in planning. Additional sites in the US and Australia are currently in start-up."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clarity's theranostic prostate cancer trial advances to multi-dose phase (PRNewswire) - P1/2a | N=44 | SECuRE (NCT04868604) | Sponsor: Clarity Pharmaceuticals Ltd | "Clarity Pharmaceuticals...is pleased to announce the successful completion of cohort 3 and advancement to cohort 4, the first multi-dose cohort in the SECuRE trial....Cohort 3 of the dose escalation phase of the trial, where 6 participants received a single administration of 12GBq of 67Cu-SAR-bisPSMA, has been successfully completed. No DLTs have been reported in any of the participants dosed in this cohort to date....Preliminary data shows that despite having high levels of PSA and having received multiple treatments, 60% (9/15) of participants across all cohorts (including the lowest dose cohort of 67Cu-SAR-bisPSMA at 4GBq) showed reductions in PSA levels of greater than 35% from a single therapy cycle of 67Cu-SAR-bisPSMA. PSA reductions of greater than 80% were seen in 27% of all trial participants."

P1/2 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Additional COBRA results: SAR-bisPSMA detects lesions in the 2-millimetre range (Clarity Pharmaceuticals Press Release) - P1/2 | N=51 | COBRA (NCT05249127) | Sponsor: Clarity Pharmaceuticals Ltd | "Clarity Pharmaceuticals...is pleased to share additional data from its diagnostic 64Cu-SAR-bisPSMA trial, COBRA (NCT05249127)....The size of the PC lesions detected by 64Cu-SAR-bisPSMA was recorded on the same-day (Day 0) and next-day (Day 1) imaging. Lesions with less than 5 mm in size were identified across readers among 14% (7/50) of patients...The SUVmax, SUVmean and TBR were assessed in up to 25 lesions per patient on the same-day and next-day 64Cu-SAR-bisPSMA PET imaging. Mean SUVmean and SUVmax increased more than 80% (82% and 87% average increase across all readers, respectively) and TBR increased almost 5 times (4.8x average increase across all readers) comparing same-day with next-day imaging (ranges among readers, Day 0 and Day 1, respectively: SUVmean 6.6-9.9 and 14.7-15.8; SUVmax 13.9-14.0 and 22.2-33.4; TBR 23.2-25.4 and 118.1-181.7)."

P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate-resistant prostate cancer. (ASCO-GU 2024) - P1/2 | "At the time of submission of this abstract, cohort 3 is open for recruitment and no dose limiting toxicities have been observed to date. Clinical trial information: NCT04868604."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

First patient dosed in Clarity's registrational Phase III prostate cancer trial with Cu-64 SAR-bisPSMA (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that the first patient has been dosed in its pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, at the Urology Cancer Center / XCancer Omaha, NE. The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastases in participants with high-risk prostate cancer prior to radical prostatectomy. The study will recruit 383 participants at multiple clinical sites across the United States and Australia."

Trial status • Prostate Cancer

PSA Undetectable in First Patient With mCRPC Given Cu-67 SAR-bisPSMA (Targeted Oncology) - "'As a clinician, there is nothing more rewarding than delivering the news to your patient that their cancer can no longer be detected, and with very few side effects following treatment, particularly for a patient that was heavily pre-treated with multiple lines of therapy, including androgen deprivation therapy [ADT], [androgen receptor pathway inhibition (ARPI)], chemotherapy and a [poly ADP ribose polymerase (PARP)] inhibitor and had failed all these treatments. For this patient who received 2 cycles of 67Cu-SAR-bisPSMA at 8 GBq, we have confirmed a near complete response through RECIST and have seen the result reflected in the reduction of PSA to an undetectable level and undetectable disease using PET,' said Luke Nordquist, MD...in a press release."

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Registrational Phase III CLARIFY trial in prostate cancer commences (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830), with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE...The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia...Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clarity's theranostic prostate cancer trial progresses at the highest dose level cohort (PRNewswire) - P1/2a | N=44 | SECuRE (NCT04868604) | Sponsor: Clarity Pharmaceuticals | "Recruitment has opened at clinical sites in the US for the additional 3 participants in cohort 3 for a single cycle of 12GBq of 67Cu-SAR-bisPSMA...Clarity Pharmaceuticals....is pleased to announce the successful completion of the first stage of cohort 3 of the Phase I/IIa theranostic trial, SECuRE, evaluating 64Cu/67Cu-SAR-bisPSMA in patients with mCRPC where 3 participants have been treated at the highest dose level of 12GBq of 67Cu-SAR-bisPSMA. No adverse events were reported in relation to 64Cu-SAR-bisPSMA. Only 1 adverse event was reported and related to the 12GBq cycle of 67Cu-SAR-bisPSMA in 1 of the 3 participants, which was a grade 1 decrease in neutrophil count, and the patient has fully recovered. No ongoing adverse events and no DLTs have been reported and the SRC has recommended the trial progresses with the 3 additional participants as planned in cohort 3."

Enrollment status • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clarity and PSI kick off SAR-bisPSMA Phase III (PRNewswire) - "Clarity Pharmaceuticals...and PSI CRO AG...have entered into an agreement and have commenced work towards Clarity's Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY (NCT06056830)....CLARIFY is expected to begin recruitment in late 2023."

Enrollment status • Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

First participant treated at the highest dose level in Clarity's theranostic prostate cancer trial (PRNewswire) - "Clarity Pharmaceutical...is pleased to announce the dosing of the first participant at the highest dose level of 12GBq in the third cohort of its Phase I/II theranostic trial evaluating 67Cu SAR-bisPSMA in participants with metastatic, castrate-resistant prostate cancer (mCRPC)...The SECuRE trial...is a Phase I/IIa theranostic trial for identification and treatment of participants with Prostate-Specific Membrane Antigen (PSMA)-expressing mCRPC using 64Cu/67Cu SAR-bisPSMA. 64Cu SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Novel PSMA theranostic continues to show high level of clinical activity in mCRPC (Urology Times) - "'We are excited by the remarkable PSA declines seen in all three patients in cohort 2 with just a single dose of 8 GBq of 67Cu SAR-bisPSMA. I have not observed PSA responses like this after a single dose of any agent and, considering the excellent safety profile we have seen to date in the first two cohorts of this study, we really look forward to progressing the development of this promising therapy....If similar responses can be replicated in larger patient numbers, 67Cu SAR-bisPSMA may become the gold standard therapeutic agent for patients with mCRPC once approved,' Luke Nordquist, MD, CEO..."

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