Clinical Trials

Inclusion Criteria:

- Ability to understand and willingness to provide informed consent, willingness to
comply with all study procedures for the duration of the study

- Male or female, aged ≥ 18 years

- Diagnosed with Stage IV metastatic melanoma, or unresectable Stage III

- Previously progressed (clinical or radiological progression) on at least one prior
therapy for metastatic melanoma

- Uptake of [68Ga]VMT02 or [203Pb]VMT01 by PET or SPECT imaging observed in at least one
melanoma tumor site using quantitative imaging analysis compared to reference normal
tissue

- Subjects on prior intravenous therapy (e.g., chemotherapy or checkpoint inhibitors),
or prior oral therapy (e.g., BRAF or MEK inhibitors) who demonstrate MC1R positivity
during screening are eligible for enrollment, provided that they undergo a wash-out
period of 21 days, or 14 days, respectively, prior to Day 1 treatment with
[212Pb]VMT01.

- Presence of measurable disease by RECIST v1.1 criteria assessed within 30 days prior
to the start of Day 1

- Ability to lie flat and still for up to two hours for imaging scans; moderate
conscious sedation allowed if indicated

- For females of reproductive potential: use of highly effective contraception for at
least one month prior to screening, and agreement to use such a method during study
participation and for an additional four weeks after the last administration of an
investigational product

- For males of reproductive potential: use of condoms or other methods to ensure
effective contraception with partner during study participation and for an additional
four weeks after the last administration of an investigational product

- ECOG performance score of < 2 at Screening

- Life expectancy of at least 3 months

- Evidence of sufficient organ function as determined by all of the following:

Oxygen saturation > 90% on room air eGFR > 50 mL/min/1.73m2 by CKD-EPI equation Complete
blood count with differential, within 7 calendar days prior to therapy and off Growth
Factors White blood cells (WBC) > 2500/mm3 Hemoglobin (Hgb) > 9.0 g/dL Platelets >
60,000/mm3 Absolute Neutrophil Count (ANC) > 1,250/mm3

The comprehensive metabolic panel, within seven calendar days prior to Day 1, demonstrating
values within the site's upper limit of normal (ULN), with the following exceptions:

Alanine aminotransferase (ALT) < 3x ULN Aspartate aminotransferase (AST) < 3x ULN Alkaline
phosphatase (ALP) < 2.5x ULN

Exclusion Criteria:

- Active secondary malignancy

- Prior treatment (for any reason) with radioactive nuclides; however, imaging tracers
are acceptable

- Pregnancy or breastfeeding a child

- Active infection

- Brain metastasis requiring acute therapy of any modality (i.e., surgical or external
beam radiotherapy) within two weeks of enrollment or clinical instability, including
signs or symptoms of brain edema. Subjects must demonstrate stable or decreasing brain
metastasis by a noninvasive imaging scan and must be off steroids or on decreasing
doses prior to enrollment.

- Treatment with another investigational drug product (therapeutic IND agents) within
the last 30 days.

- Current abuse of alcohol or illicit drugs

- Existence of any medical or social issues likely to interfere with study conductor
that may cause increased risk to the subject or to others, e.g., lack of ability to
follow radiation safety precautions

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/21/2024. Questions regarding updates should be directed to the study team contact.