Testing HYP-2090PTSA in patients with advanced solid tumors and KRAS mutations

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 multicenter, open-label phase 1/2 study evaluates the safety, tolerability, and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors that have a KRAS mutation. The study consists of two parts: a dose escalation phase to determine the recommended phase 2 dose (RP2D) and a dose expansion phase to further explore the efficacy and safety of the drug at the RP2D in patients with specific KRAS p.G12C mutations. Participants will be monitored for measurable lesions and overall health status throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
* 18 Years and older;
* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;
* Subjects must have at least one measurable lesion as defined by RECIST v1.1;
* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
* Expected survival ≥ 3 months;
* Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.

Exclusion Criteria:

* Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;
* Patients who have received live vaccines within 4 weeks prior to the first dose;
* Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;
* Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;
* Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;
* Patients who have previously received allogeneic tissue/solid organ transplantation;
* Patients with active infection;
* Patients who are positive for human immunodeficiency virus (HIV) (HIV1/2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \> 500 IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA \> lower limit of detection by the research center);
* Female subjects who are lactating or have a positive blood/urine pregnancy result during the screening period;
* Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.

Where it's running

• Fujian Provincial Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Hunan Provincial Cancer Hospital
  Changsha, Hunan, China Not yet recruiting
• The first Hospital of China Medical University
  Shenyang, Liaoning, China Not yet recruiting
• Shandong Provincial Cancer Hospital
  Jinan, Shandong, China Not yet recruiting

Study contacts

• Study coordinator: Kai Chang
• Email: kai.chang4086@huiyupharma.com
• Phone: +86-028-86021875

Similar studies

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

• GenSci142 as a vaginal treatment for bacterial vaginosis

  This study tests whether GenSci142 given as vaginal doses is safe and may help BV patients aged 18–50 compared with clindamycin cream.

  Recruiting at 9 sites Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07663838

• GenSci098 for adults with Graves' disease

  This phase 1 trial will test single increasing subcutaneous doses of GenSci098 to see if they are safe and well tolerated in adults with Graves' disease.

  Recruiting Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Shenyang, Liaoning · NCT07286656

• GenSci134 in healthy adults and adults with growth hormone deficiency

  This Phase 1 trial will test single and multiple subcutaneous doses of GenSci134 in healthy adults and single doses in adults with growth hormone deficiency to check safety, tolerability, pharmacokinetics, pharmacodynamics, and immune response.

  Recruiting Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07016802

• Evaluating the safety and tolerability of RCS-21 in healthy volunteers

  This study is testing a new inhaled medication called RCS-21 to see how safe it is and how well it works in healthy volunteers.

  Recruiting Phase 1 RNATICS GmbH · Hanover · NCT06752122

• Evaluating HY07121 for patients with advanced solid tumors

  This study is testing a new drug called HY07121 to see if it is safe and effective for people with advanced solid tumors.

  Recruiting Phase 1/2 Sichuan Huiyu Pharmaceutical Co., Ltd · Jinan · NCT06639256

• Evaluating GenSci098 for treating active thyroid eye disease

  This study is testing a new treatment called GenSci098 to see if it is safe and helpful for people with active thyroid eye disease linked to Graves' disease.

  Recruiting Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT06569758

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.