Cancer CachexiaPhase 1/2NCT07735104
The First in Human Study of QLS2319 in Healthy Subjects and Cancer Cachexia
A Phase 1/2 study testing QLS2319 in people with Cancer Cachexia and Cancer Cachexia Syndrome, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Cachexia, Cancer Cachexia Syndrome
- What is being tested?
- QLS2319
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesChina
- Study dates
- 16 Sep 2026to 31 Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ia phase:
- Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.;
- Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive);
- Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose;
- Ib phase:
- Subjects aged ≥ 18 years at screening;
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- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
- ECOG performance status score of 0, 1;
- Cancer cachexia documented in medical records; -
Who cannot join
- Ia phase:
- Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study.
- History of HIV infection, syphilis, hepatitis B, or hepatitis C;
- History of recurrent infections or active infections；
- Subjects who, in the judgment of the investigator, are not suitable for participation in the study.
- Ib phase:
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- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product
- Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food.
- Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Sun-Yat-sen University Cancer Center
Guangzhou, Guangdong
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS2319 for Injection/Placebo Following Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Subjects With Cancer Cachexia.
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
Read the detailed description
This study is a first-in-human, dose-escalation trial in healthy adult participants and cancer cachexia to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of QLS2319.
The target population of dose escalation part is healthy adult participants, and the dose expansion part will enroll patients with cancer cachexia.
- Conditions
- Cancer Cachexia, Cancer Cachexia Syndrome
- Being tested
- QLS2319, Placebo
- Keywords
- QLS2319, cancer cachexia, cancer cachexia syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS2319Drug
QLS2319 will be administered via subcutaneous injection
PlaceboDrug
placebo will be administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QLS2319 | Experimental | QLS2319 s.c. Receives: Drug: QLS2319 |
| placebo | Placebo comparator | placebo s.c. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
Measured: Up to Day 99
Phase Ib：Safety and tolerability after multiple subcutaneous injections of QLS2319
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start16 Sep 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735104
- Sponsor's protocol ID
- QLS2319-101
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No