Testing SHR-9839 injections for adults with advanced solid tumors

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors

This will test SHR-9839 injections to see if they are safe and show anti-tumor activity in adults with unresectable or metastatic solid tumors who have exhausted or lack standard treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05836948 on ClinicalTrials.gov

What this trial studies

This open-label phase I trial of SHR-9839 is being conducted in three parts: dose escalation to identify a tolerable dose, dose expansion to further characterize safety, and an efficacy expansion to look for preliminary anti-tumor activity. Eligible patients must have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, at least one measurable lesion by RECIST v1.1, ECOG 0–1, and adequate organ function. Key endpoints focus on safety, tolerability, recommended phase II dose, and early signs of efficacy. The trial is sponsored by Shanghai Hengrui Pharmaceutical and conducted at Zhejiang Tumor Hospital in Hangzhou, China.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that are relapsed or refractory to standard treatment or for whom standard treatment is not available, who have at least one measurable lesion, ECOG 0–1, life expectancy of at least 12 weeks, and adequate organ and bone marrow function.

Not a fit: Patients with active central nervous system or meningeal metastases, recent anti-tumor therapy within 4 weeks, significant cardiovascular or cerebrovascular disease, prior high-dose radiation (>30 Gy), or inadequate organ function are excluded and therefore unlikely to benefit from participation.

Why it matters

Potential benefit: If SHR-9839 is effective and safe, it could provide a new treatment option that helps control tumor growth for some patients with advanced solid tumors.

How similar studies have performed: Phase I trials of other investigational cancer agents have occasionally shown early signals of benefit, but SHR-9839's safety and effectiveness in patients have not yet been established.

Eligibility criteria

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function;
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
3. History of serious cardiovascular and cerebrovascular diseases;
4. Subjects who received\>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Tumor Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Rongfu Mao, MD

Conditions: Advanced Solid Tumor