NCT07459283

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
8mo left

Started Apr 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 4, 2026

Last Update Submit

March 8, 2026

Conditions

SarcomaMaligant Solid TumorHead & Neck CancerThyroid CancerLung Cancer - Non Small Cell SquamousBreast Cancer

Outcome Measures

Primary Outcomes (3)

  • Determine dose-limiting toxicity (DLT)

    Determine the DLT of INN805

    42 days after first dose

  • Frequency of adverse events (AEs) and SAEs

    To investigate the safety characteristics of INN805

    Approximately 12 months

  • Determine the Maximum Tolerated Dose (MTD)

    Determine the MTD of INN805

    Approximately 12 months

Secondary Outcomes (3)

  • Objective response rate (ORR)

    Approximately 12 months

  • Disease control rate (DCR)

    Approximately 12 months

  • Progression free survival (PFS)

    Approximately 12 months

Study Arms (1)

INN805 injection

EXPERIMENTAL
Drug: INN805

Interventions

INN805DRUG

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

INN805 injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 75 years old male and female.
  • Patients with advanced malignant solid tumors who have failed standard treatments.
  • According to RECIST 1.1, there is at least one measurable lesion.
  • ECOG performance status 0-1.
  • Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥100×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method

You may not qualify if:

  • Received anti-tumor therapy within 4 weeks before enrollment.
  • Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
  • Have undergone surgery within 4 weeks before enrollment.
  • Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
  • Central nervous system metastases with clinical symptoms.
  • With any situations that the researcher considers inappropriate to participate in this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid NeoplasmsBreast NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Central Study Contacts

Tingjin Wang

CONTACT

18664044814wangtingjin@find-cure.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)