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Sponsored by: Fusion Pharmaceuticals Inc.

What phase is this trial?

This is a Phase 2/3 clinical trial.
Phase 2/3 trials are designed to further evaluate the safety and effectiveness of a treatment after initial safety has been established. This means the treatment is still investigational, but researchers are gathering more information on how well it works and how safe it is for a larger group of patients.

What is this study about?

This study is testing a new treatment called FPI-2265 (225Ac-PSMA-I&T) for people with metastatic castration-resistant prostate cancer (mCRPC) that is positive for PSMA (prostate-specific membrane antigen). You may qualify if you have already been treated with a previous PSMA-targeted radioligand therapy, such as 177Lu-PSMA-617 or a similar medication.

How does FPI-2265 work?

FPI-2265 is a radiopharmaceutical therapy—a medicine designed to deliver targeted radiation directly to prostate cancer cells. It uses actinium-225, a radioactive particle, attached to a molecule that finds and binds to PSMA on cancer cells. This targeted approach aims to destroy cancer cells while limiting damage to healthy tissue.

For Patient eligibility and locations

Please click here to see complete list of requirements and locations.

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Sponsored by: Aktis Oncology, Inc.

Study Overview

Brief Summary

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Part 2 dose.

Detailed Description

This study consists for two parts (Part 1 and 2).

Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic urothelial cancer. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Part 2 dose.

Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy on [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

Official Title

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors.

Conditions

Urothelial Carcinoma Bladder
Triple Negative Breast Cancer (TNBC)
Hormone Receptor Positive Breast Adenocarcinoma
Non Small Cell Lung Cancer
Cervical Adenocarcinoma
Colorectal AdenocarcinomaHead and Neck Cancer

Intervention / Treatment

Drug: [225Ac]Ac-AKY-1189 (therapeutic)
Drug: [64Cu]Cu-AKY-1189 (imaging)

Other Study ID Numbers

AKY-1189-01

For Patient eligibility and locations

Please click here to see complete list of requirements and locations.

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Sponsored by: Fusion Pharmaceuticals Inc.

Study Overview

Brief Summary

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.

Detailed Description

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity.

Screening Period: At screening, participants will be assessed for eligibility and undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized.

Participants randomized will enter the treatment period and receive investigational doses of FPI2265 according to the dose level and schedule as specified per proposed dose arm.

Part A participants will enroll 1:1:1 at three dose level/schedules, to arms 1, 2 or 3

Part B participants will enroll after completion of part A, in a 1:1 randomization scheme to arms 6 or 7.

Once Part A is fully enrolled and participants have been followed for at least 12 weeks, data from Arm 1 and 2 will be analyzed to assess the the feasibility of enrolling participants to arms 4 and 5.

All participants will be monitored and assessed for efficacy response, disease progression and adverse events.

Supportive care will be allowed in all arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT).

Follow-up after end of treatment visit will proceed for 5 years.

5 participants will be enrolled into a dosimetry substudy (open at select sites only). Dosimetry substudy participants will be administered one dose at of FPI2265 and proceed with dosimetric assessments will be taken at a number of timepoints after dose administration.

Official Title

A Phase 2/3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Conditions

Metastatic Castration-resistant
Prostate Cancer

Intervention / Treatment

Drug: FPI-2265

Other Study ID Numbers

FPI-2265-202

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Sponsored by: Orano Med LLC

Study Overview

Brief Summary

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors

Detailed Description

In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, adult subjects with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a TITE Boin design for the MAD cohorts. Dose escalation may proceed until the recommended MAD dose is determined. Up to four (2 SAD and 2 MAD) cohorts are expected to be enrolled. Subjects will be treated with up to four cycles administered every 8 weeks. Once the recommended MAD dose is determined, the expansion cohorts of the study will commence. A dosimetry sub study will also be conducted in which participants will receive a single injection of 203Pb-DOTAM-GRPR1 with 1 week follow-up.

Official Title

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors

Conditions

Cervical Cancer
Prostate Cancer Metastatic
Breast Cancer
Colon Cancer
NSCLC
Cutaneous Melanoma

Intervention / Treatment

Drug: ²¹²Pb-DOTAM-GRPR1

Other Study ID Numbers

OM-GRPR1-02

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Sponsored by: Telix Pharmaceuticals (Innovations) Pty Limited

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Detailed Description

The primary objective of the study is to compare radiographic progression-free survival (rPFS) in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only.

This study consists of three Parts:

Part 1: Safety and Dosimetry Lead-in,
Part 2: Randomized Treatment Expansion, and
Part 3: Long-term Follow-up

The study will commence with a 30-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment expansion in approximately 490 patients (Part 2).

Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX591 + Standard of Care SoC (Group A), or SoC alone (Arm B).

SoC in this trial is either: ARPI (enzalutamide or abiraterone) or docetaxel.

All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3).

Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review (BICR) will be eligible for this study.

Official Title

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment

Conditions

Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment

Drug: 177Lu-TLX591
Drug: Enzalutamide
Drug: Abiraterone
Drug: Docetaxel

Other Study ID Numbers

177Lu-TLX591-203

For Patient eligibility and locations
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Sponsored by: Telix Pharmaceuticals (Innovations) Pty Limited

Study Overview

Brief Summary

The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.

Official Title

An Expanded Access Program for the Non-invasive Detection of Clear Cell Renal Cell Carcinoma (ccRCC) in Patients With Renal Masses Utilizing 89Zirconium-labelled Girentuximab (89Zr-DFO-girentuximab)

Conditions

Clear Cell Renal Cell Carcinoma

Intervention / Treatment

Diagnostic Test: 89Zr-DFO-girentuximab

Other Study ID Numbers

89Zr-TLX250-007

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Sponsored by: Telix Pharmaceuticals (Innovations) Pty Limited

Study Overview

Brief Summary

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

Detailed Description

This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy.

Patients, will be recruited in 12-15 renal cancer care specialist centres, who have access to state-of-the-art PET/CT imaging equipment.

The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted 5 +/-2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.

On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator.

Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.

Official Title

A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

Conditions

Clear Cell Renal Cell Carcinoma

Intervention / Treatment

Diagnostic Test: 89Zr-girentuximab

Other Study ID Numbers

89Zr-TLX250-003

For Patient eligibility and locations
Please click here to see complete list of requirements and locations.

If you are interested in more information about this trial

Please fill out this form.