Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials

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An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntarily participate and sign the informed consent form

• At least 18 years old, male or female

• Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;

• Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)

• Subjects with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Expected survival period ≥ 12 weeks

• Adequate organ and bone marrow function

• Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration

Locations
Other Locations
China
Chongqing Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital
RECRUITING
Jinan
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
the First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Contact Information
Primary
Jiawei Yao
yaojiawei@zaiming.com
+8618868816194
Time Frame
Start Date: 2026-01-19
Estimated Completion Date: 2029-07
Participants
Target number of participants: 260
Treatments
Experimental: Dose escalation
SIM0610 administered intravenously at selected dose levels according to protocol
Experimental: Cohort expansion
SIM0610 administered intravenously at Recommended dosage(RDs) according to protocol
Sponsors
Leads: Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Shanghai Xianwei Medical Technology Co., Ltd.

This content was sourced from clinicaltrials.gov