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An Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia

NCT07584057 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-05-13

No results posted yet for this study

Summary

This is an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia.

The indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit/risk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.

Conditions

  • Cancer Cachexia

Interventions

BIOLOGICAL

INB301 Injection

The screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose. Each 1 mL of INB301 Injection contains 100 mg of the drug, and 2 mL of the drug can be injected at each subcutaneous injection site, which is at the left and right abdominal subcutaneous tissue, as well as the left and right arm subcutaneous tissue. The specific dose is determined according to the dose cohort. Dosing every 3 or 4 weeks is proposed.

Sponsors & Collaborators

  • Yunnan Baiyao Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-02-28
Completion
2030-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584057 on ClinicalTrials.gov