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Gastrointestinal Diseases

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Paragangliomas 1

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All Drugs and Chemicals

Radiopharmaceuticals

Dose Escalation to determine MTD/MFD in 32 patients receiving up to 4 administrations of \[212Pb\]VMT-α-NET approximately 8 weeks apart.

A dosimetry sub-study utilizing \[203Pb\]VMT-α-NET has been incorporated into the study.

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered every 8 weeks for a maximum of four doses

[212Pb]VMT-α-NET

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered at the RPh2D and schedule determined in Phase I dose escalation

Markus Puhlmann, MD, MBA

Jason Starr, MD

Chih-Yi Liao, MD

Yusuf Menda, MD

Yvonne Taul

Lowell Anthony, MD, FACP

Lilja Solnes, MD

Neda Tehrani

Thorvardur R Halfdanarson, MD

John Crandall

Richard Wahl, MD

Samuel Mehr, MD

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

This is a prospective, multi-center open-label dose escalation, dose expansion study of \[212Pb\]VMT01 in up to 52 adult subjects with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) who have not received prior peptide receptor radionuclide therapy (PRRT).

The radioactivity dose escalation period (phase I) tests up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose.

Pre-specified dose adjustments and individual stopping rules for repeat treatment cycles are based on observed dose-limiting toxicities (DLTs) and adverse events (AEs).

The Maximum Tolerated Dose (MTD) will be determined based on observed DLTs within 42 days of the first treatment cycle.

The recommended expansion dose(s) will be determined following a holistic analysis of observed DLTs, AEs, estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.

If MTD can not be identified within the 4 radioactivity dose cohorts, a Maximum Feasible Dose (MFD), incorporating manufacturing and logistical considerations for \[212Pb\]VMT-α-NET production, may be determined.

Reno-protective amino acids will be co-administered in a separate IV line prior to each \[212Pb\]VMT-α-NET dose in all subjects. Escalation will be based on a modified toxicity probability interval design \[mTPI-2\] until MTD is identified or the pre-specified rules are met.

A lead-in dosimetry sub-study will be conducted during the dose escalation period in which all subjects in the first two dose cohorts will undergo dosimetric evaluation prior to receiving the therapeutic agent.

A Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT-α-NET and which does not necessarily have a causal relationship with this treatment

Determination of the overall response rate (ORR) by RECIST v1.1 in subjects with neuroendocrine tumors

Biodistribution will be calculated by utilizing SPECT/CT scans.

Perspective Therapeutics

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy.

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Julie L Sutcliffe, Phd

Julie L Sutcliffe

Julie L Sutcliffe, PhD

This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.

This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. \[68Ga\]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the \[177Lu\]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue.

We hypothesize that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair \[68Ga\]Ga DOTA-5G/ \[177Lu\]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of \[177Lu\]Lu DOTA-ABM-5G.

Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas

A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas

To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic cancer

To assess the safety and tolerability of a single treatment with \[177Lu\]Lu DOTA-ABM-5G

To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second \[68Ga\]Ga DOTA-5G PET/CT, prior to next line of therapy.

National Institutes of Health (NIH)

University of California, Davis

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pluvicto

Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.

177Lu-PSMA-617

Declan Murphy

Michael S Hofman

John Violet

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer

Biochemical recurrence (BCR) will be measured from the time of surgery to the first rise of the PSA to ≥0.2 ng/mL

Determination of the relationship between screening PSMA PET imaging parameters including molecular tumour volume parameters and absorbed dose in the prostate and involved lymph nodes

Determination of relevant predictive biomarkers associated with treatment outcomes and response

Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)

PSMA PET response to therapy (complete metabolic response, partial metabolic response, stable metabolic disease, progressive metabolic disease)

Pathological response (complete response, minimal residual disease)

Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5

Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications

QoL indices will be scored using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

QoL indices will be scored using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire

Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors	NCT05636618	Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Carcinoid Tumor... Carcinoid Tumor Paraganglioma Pheochromocytom...	[212Pb]VMT-α-NE... [212Pb]VMT-α-NE...	18 Years - 90 Years	Perspective Therapeutics
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas	NCT06389123	Metastatic Canc...	[68Ga]Ga DOTA-5...	18 Years -	University of California, Davis
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy	NCT04430192	Prostatic Neopl...	177Lu-PSMA-617	18 Years -	Peter MacCallum Cancer Centre, Australia
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy	NCT04430192	Prostatic Neopl...	177Lu-PSMA-617	18 Years -	Peter MacCallum Cancer Centre, Australia

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