The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors

Sponsor
FindCure Biosciences (ZhongShan) Co., Ltd.
Study ID
NCT07459283
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer
  • Head & Neck Cancer
  • Lung Cancer - Non Small Cell Squamous
  • Maligant Solid Tumor
  • Sarcoma
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • INN805 — DRUG
    The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.

Study Details

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

Key Dates

First listed
Mar 9, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: INN805 injection

Primary Outcome Measure

Determine dose-limiting toxicity (DLT) [ Time Frame: 42 days after first dose ]

Central Contacts

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