Testing SHR-9839 injections for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhejiang Tumor Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Rongfu Mao, MD
• Email: rongfu.mao@hengrui.com
• Phone: +86 021-61053363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SGT003 in people with advanced solid tumors

  This early-phase study tests SGT003 in adults with advanced solid tumors to see if it is safe and tolerable and to get a first look at how it behaves in the body and any early signs of benefit.

  Recruiting Phase 1/2 Beijing Sungen Biomedical Technology Co., Ltd · Beijing, Beijing Municipality · NCT07811037

• YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors

  A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.

  Recruiting Early Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07793500

• Personalized neoantigen-pulsed dendritic cell injections for malignant solid tumors

  This study tests personalized dendritic cell injections, with or without immune checkpoint inhibitors, to see if they are safe and can help patients with advanced solid tumors.

  Recruiting ZSky Biotech Inc · Qinhuangdao, Hebei · NCT07752953

• STX-003 in advanced solid tumors given by IV, alone or with pembrolizumab

  This study tests STX-003, given by IV, to see if it is safe and potentially effective for patients with advanced solid tumors, either alone or with pembrolizumab.

  Recruiting at 4 sites Phase 1/2 Strand Therapeutics Inc. · Scottsdale, Arizona and 3 other locations · NCT07751042

• ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors

  This study tests ARV-6723, by itself or with pembrolizumab, to see if it is safe and could help the immune system fight advanced solid tumors in adults.

  Recruiting at 4 sites Phase 1/2 Arvinas Inc. · New York, New York and 3 other locations · NCT07749586

• BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors

  This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.

  Recruiting at 3 sites Phase 1 BeOne Medicines · South Brisbane, Queensland and 2 other locations · NCT07746141

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.