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

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT) (clinicaltrials.gov) - P1/2 | N=4 | Terminated | Sponsor: Clarity Pharmaceuticals Ltd | N=38 ➔ 4 | Trial completion date: May 2026 ➔ Apr 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Apr 2025; Sponsor Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

COMBAT: A study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for identification and treatment of GRPr-expressing metastatic castrate resistant prostate cancer ineligible for therapy with 177Lu-PSMA-617 (SNMMI 2024) - P1/2 | "Not applicable."

Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1 • GRP-10

COMBAT: A study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for identification and treatment of GRPr-expressing metastatic castrate-resistant prostate cancer. (ASCO-GU 2024) - P1/2 | "Prostate-specific membrane antigen (PSMA)-targeted theranostic agents, 68Ga-PSMA-11 and 177Lu-PSMA-617, have been approved by the FDA for patient selection and therapy for patients with mCRPC, respectively. At the time of submission of this abstract, cohort 1 is open for enrollment. Clinical trial information: NCT05633160."

Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1 • GRP-10

First patient treated with Cu-67 SAR-Bombesin in theranostic prostate cancer trial (PRNewswire) - P1/2a | N=38 | COMBAT (NCT05633160) | Sponsor: Clarity Pharmaceuticals Ltd | "Clarity Pharmaceuticals...is pleased to announce the dosing of the first patient in its theranostic 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer (mCRPC). No issues were observed during the administration of 6GBq of 67Cu SAR-Bombesin and the participant continues to be followed for further safety and efficacy assessments as per protocol...COMBAT, which derives from 'Copper-67 SAR-Bombesin in metastatic castrate resistant prostate cancer (NCT05633160) is a dose escalation and cohort expansion trial for up to 38 participants."

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

Clarity commences COMBAT theranostic prostate cancer trial in the US (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce it has commenced its 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer (mCRPC) with the opening of the first site at BAMF Health, Inc in Michigan. COMBAT (Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer, NCT05633160) is a dose escalation and cohort expansion trial for up to 38 participants. The aim for the trial is to determine the safety and efficacy of 67Cu-SAR-Bombesin in participants with gastrin-releasing peptide receptor (GRPr) expressing mCRPC in patients who are ineligible for therapy with 177Lu PSMA-617."

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

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT) (clinicaltrials.gov) - P1/2 | N=38 | Recruiting | Sponsor: Clarity Pharmaceuticals Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Recruitment complete for Phase II prostate cancer trial (Clarity Pharmaceuticals Press Release) - "Clarity Pharmaceuticals...is pleased to announce the completion of recruitment for the Phase II investigator initiated diagnostic trial, BOP (NCT05613842), evaluating its 64Cu-SAR-Bombesin product in 30 participants with prostate cancer."

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT) (clinicaltrials.gov) - P1/2 | N=38 | Not yet recruiting | Sponsor: Clarity Pharmaceuticals Ltd

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

First participant imaged in Phase II SAR-Bombesin prostate cancer trial in the US (Clarity Pharmaceuticals Press Release) - "Clarity Pharmaceuticals...is pleased to announce it has successfully imaged its first participant in the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1for patients with PSMA-negative prostate cancer....It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer....'Subject to the outcome of the SABRE trial, Clarity is planning to launch a pivotal Phase III diagnostic trial for first product approvals in the US. We are also preparing to run a theranostic trial with an Investigational New Drug (IND) application scheduled for submission to the US Food and Drug Administration (FDA) later this year'."

IND • New P3 trial • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Recruitment opens for Phase II trial in prostate cancer with Cu-64 SAR-Bombesin in the US (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311) for patients with PSMA-negative prostate cancer is open for recruitment....It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants....'We look forward to expanding the trial sites and generating data for this next-generation product which could ensure both ease of access and improved treatment outcomes for BCR prostate cancer patients...'"

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

IND approval from the US FDA for Phase II SAR-Bombesin imaging trial in prostate cancer (PRNewswire) - "Clarity Pharmaceuticals...announces the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative."

IND • Oncology • Prostate Cancer • Solid Tumor