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New treatment option for Solid Tumors
Official title A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06783569
What this study is testing
What is JR8603?
JR8603 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who meet ALL the following will be eligible to participate in the study:
- ≥18 years of age.
- Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no...
- Measurable disease per RECIST v1.1.
- Life expectancy ≥3 months.
You likely can't join if
- Patients who meet any of the following exclusion criteria will be excluded from participation in the study:
- Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully...
- Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an...
- Major surgery within 3 weeks prior to start of study drug treatment.
- Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to...
- Severe or unstable cardiac conditions including, but not limited to, congestive heart failure (New York Heart Association Class III or IV), ischemic...
See the full eligibility criteria
Who can join
- Patients who meet ALL the following will be eligible to participate in the study:
- ≥18 years of age.
- Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is...
- Measurable disease per RECIST v1.1.
- Life expectancy ≥3 months.
- Adequate organ and bone marrow function defined by:
- Absolute neutrophil count (ANC) ≥1.5 × 109/L (≥1500/mm3)
- Platelet count ≥100 × 109/L (≥100,000/mm3) (no platelet transfusion within 14 days prior to enrollment)
- Total bilirubin ≤1.5 × upper limit of normal (ULN), unless known Gilbert syndrome (≤3 × ULN) has been diagnosed
- AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases
- Estimated creatinine clearance by the Cockcroft-Gault or estimated glomerular filtration rate (eGFR) of ≥60 mL/min
- International Normalized Ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. If a patient is receiving anticoagulant therapy, PT and aPTT must be within therapeutic range of...
- Patients with treated, stable central nervous system (CNS) metastases (including leptomeningeal carcinomatosis) are allowed if there is no evidence of progression for at least 4 weeks after CNS-directed treatment as...
- Resolution of any clinically significant toxic effects of prior therapy to Grade ≤1 according to the NCI CTCAE v5.0 (exception of alopecia and Grade 2 peripheral neuropathy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willingness of men and women of reproductive potential to observe conventional and effective birth control methods with failure rates of \<1% for the duration of treatment and for at least 6 months for women and at...
- Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
- Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion/ligation
- Vasectomized partner
- Sexual abstinence Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The...
- Periodic abstinence (calendar, symptothermal, or post-ovulation methods)
- Withdrawal (coitus interruptus)
- Spermicide only
- Lactational amenorrhea method Egg and sperm donation or banking is prohibited during the duration of participation on this protocol and for 90 days after the last dose of study drug. 10. A negative serum pregnancy test...
- Prior systemic standard therapy for patients with HER2-positive gastric or EGJ cancer should include trastuzumab plus chemotherapy (fluorouracil plus platinum), mono-chemotherapy (eg., paclitaxel, docetaxel...
- Prior system standard therapy for patients with HER2-negative gastric or EGJ cancer should include fluorouracil plus platinum or in combination with anti-PD-1, mono-chemotherapy (eg., paclitaxel, docetaxel, irinotecan)...
- Prior systemic standard therapy for patients with MMR-deficient (dMMR)/microsatellite instability-high (MSI-H): pembrolizumab for 1st line therapy, no standard therapy for 2nd and 3rd line therapy.
- Prior system standard therapy for patients with microsatellite stability (MSS) or microsatellite instability-low (MSI-L)/proficient mismatch repair (pMMR), RAS and BRAF wild-type (WT) should include cetuximab or...
- Prior system standard therapy for patients with MSS or MSI-L/pMMR, RAS and BRAF mutation: should include bevacizumab monotherapy or in combination with FOLFIRI, and monotherapy (eg., regorafenib, fruquintinib...
What rules you out
- Patients who meet any of the following exclusion criteria will be excluded from participation in the study:
- Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
- Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter)...
- Major surgery within 3 weeks prior to start of study drug treatment.
- Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study drug treatment). Patients must have recovered from all...
- Severe or unstable cardiac conditions including, but not limited to, congestive heart failure (New York Heart Association Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled cardiac...
- Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
- Has a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion...
- Active infection requiring systemic therapy (including asymptomatic infections with positive virus titers and the Investigator's judgment that worsening of the condition is likely with study drug or the condition will...
- Known human immunodeficiency virus, hepatitis B virus (HBV) (i.e., hepatitis B surface antigen positive), or hepatitis C virus (HCV) (i.e., detectable HCV ribonucleic acid [RNA]). Note: Patients with a prior history of...
- Pregnant (or intending to become pregnant) or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heiljiang Province, China
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heiljiang Province, China; Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.