177Lu-HTK03170 for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cancer treatment on people with mCRPC. The study will measure how well the treatment works and how safe it is.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, despite previous treatments like abiraterone or enzalutamide. They must have good blood counts, kidney and liver function, be able to follow the trial procedures, and use contraception if necessary. Excluded are those who've had recent cancer therapies or surgeries, active heart disease, other cancers, brain metastases or certain conditions affecting saliva production.

What is being tested?

The study tests a new radioactive drug called 177Lu-HTK03170 in men with PSMA-positive mCRPC. The treatment amount will increase each cycle based on personalized calculations from imaging results. Researchers will monitor tumor response through scans and blood tests for two years or until the disease progresses.

What are the potential side effects?

Possible side effects include radiation-related risks such as nausea and fatigue; damage to organs near tumors; changes in blood cell counts leading to increased infection risk; potential kidney impairment; and dry mouth if salivary glands absorb some of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the number of subjects with markedly abnormal laboratory tests (including ECG) at least once post-injection

To determine the MTIA or a recommended safe initial IA of 177Lu-HTK03170 to measure dosimetry and initiate treatment

To determine the antitumour effect of 177Lu-HTK03170 therapy measured by radiographic ORR per RECIST v1.1 in subjects who have PSMA-positive mCRPC

+3 more

Secondary study objectives

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

Duration of PSA responses

Duration of radiographic response

+5 more

Other study objectives

To assess the dose-response relationship between radiation delivered to tumour lesions and radiographic objective response

To assess whether circulating tumour DNA/RNA can be used to predict treatment response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 177Lu HTK03170 Phase I/IIExperimental Treatment2 Interventions

Phase I, the administered activity will be 1.1 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes. Initial Activity (IA) escalation will only occur on the initial dosimetry IA, with an increase of 30% over the initial IA (used for dosimetry) at each subsequent level ( 1.65 GBq, 2.5 GBq, 3.7 GBq) in up to 12 participants. Personalized dosimetry will be calculated for each subject. Phase II, subjects will be treated with an initial IA of 177Lu-HTK03170 at the MTIA as determined during Phase I or 13.7 GBq whichever is lower. Treatment is administered as an intravenous infusion over a time of 10 - 30 minutes. Personalized dosimetry will be calculated for each subject so that subsequent treatments will be estimated to remain within the absorbed cumulative dose limits of 28Gy and 35Gy for kidneys and salivary glands, adjusted iteratively over the 4 remaining treatment cycles separated by 8 weeks. Up to 32 subjects will be enrolled to continue efficacy evaluation.

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