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Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer

ConditionRadioiodine Refractory Differentiated Thyroid Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPeking Union Medical College Hospital

About this trial

177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must have the ability to understand and sign an approved informed consent form (ICF).

Aged 18 years or older, regardless of sex.

Histologically or cytologically confirmed RAIR-DTC subject who has failed TKIs treatment or refuse standard therapy.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Disqualifiers

Subject without clinical symptoms can be included in this trial after evaluation by the investigator.

Brain metastases that have been previously treated and confirmed by image to be stable for at least 4 weeks.

Secondary malignancy was detected within 5 years prior to first dosing, excluding cured localized carcinoma including cervical carcinoma in situ, basal cell skin cancer, and prostate cancer in situ, etc.

Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.

Trial design

Design model

Single group

Treatments tested in this trial

  • 177Lu-LNC1004 Injection

    Drug

    Intravenous administration: a single dose of 80 mCi per Cycle

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: 177Lu-LNC1004 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).

Time frame
up to 24 months

Secondary outcomes

1

Disease Control Rate (DCR)

DCR is defined as the proportion of subjects who achieve a best overall response of CR, PR or Stable Disease (SD).

Time frame
up to 24 months
2

Duration of Response (DoR)

DoR is defined as the time from the earliest date of documented CR or PR until documented disease progression or death, whichever occurs first.

Time frame
up to 24 months
3

Progression Free Survival (PFS)

PFS is defined as the time from the first dose of 177Lu-LNC1004 Injection to the date of documented disease progression or death, whichever occurs first.

Time frame
up to 24 months
4

Biochemical Response (BR)

BR is defined as the percentage of change in serum Thyroglobulin (Tg) from baseline.

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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