Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2027

Conditions
Solid Tumor Malignancy
Interventions
DIAGNOSTIC_TEST

68Ga-NRT6020 Injection

Participants will receive a single intravenous injection of 68Ga-NRT6020 Injection (3 mCi or 5 mCi) and PET/CT scans at multiple time points.

DRUG

177Lu-NRT6020 Injection (stage 2)

It is planned to evaluate 4 dose levels of 177Lu-NRT6020 Injection: 50mCi, 100mCi, 150mCi and one/more adaptive dose groups (ranged from 150 to 250 mCi, the specific doses and/or doses with other frequencies within the range of 150\~250mCi, need to be determined after the completion of the dose-limiting toxicity (DLT) assessment for the previous three dose groups, in combination with the safety, pharmacokinetics and radiation dosimetry results of the participants, following confirmation by the SRC) which will be administered every 6 weeks (Q6W), and/or other dosing intervals determined by the SRC, for up to 6 cycles.

DRUG

177Lu-NRT6020 Injection (stage 3)

Participants will receive intravenous injection of 177Lu-NRT6020 Injection, administered Q6W and/or other dosing intervals determined by the SRC, for up to 6 cycles.

All Listed Sponsors
lead

Chengdu New Radiomedicine Technology Co. LTD.

INDUSTRY