An Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Prelimina… (NCT07584057) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
An Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia
China146 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who voluntarily participate in the study and voluntarily sign the informed consent form;
* Male or female ≥ 18 years of age;
* Subjects with histologically or cytologically confirmed malignant solid tumors (including pathologically confirmed non-small cell lung cancer, colorectal cancer, pancreatic cancer, esophageal cancer or breast cancer, etc.) who are receiving or have completed anti-cancer treatment and have no significant cancer progression 28 days before the first dose, and in the investigator's expectation are unlikely to change the anti-cancer regimen due to disease progression or do not require any anti-cancer treatment within the first cycle (21 days) of the study;
* Definitely diagnosed as cancer cachexia according to the 2025 Definition and Classification of Cancer Cachexia: An International Consensus" combined with clinical practice: one of the following occurs within 6 months (recognized documentation is required for past weight data): involuntary weight loss \> 5%, or weight loss \> 2% when BMI \< 18.5 kg/m² ;
* Serum GDF-15 level ≥ 1200 pg/mL within 28 days prior to the first dose (only applicable to Phase I dose expansion and Phase IIa);
* Adequate organ function, i.e., meeting laboratory criteria:
* Hematology: absolute neutrophil count ≥ 1.0×10⁹/L, platelets ≥ 75×10⁹/L, hemoglobin ≥ 80 g/L;
* Renal: serum creatinine ≤ 1.5 × ULN (if serum creatinine \> 1.5 × ULN, creatinine clearance calculated with Cockcroft formula ≥ 3…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: Through study completion, an average of 1 year.
2
Mean change in body weight from baseline during each assessment period within 12 weeks.
Timeframe: Through study completion, an average of 1 year.