A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Gastric Cancer, Esophagogastric Juction Cancer, Colorectal Cancer

In brief

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.

Key facts

Study ID: NCT06783569
Run by: JiaRay Group
People needed: 94
Starts: 2024-12-31
Expected to finish: 2026-07-01
Last updated by the study team: 2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who meet ALL the following inclusion criteria 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 refused by the patient.
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 intended use of anticoagulants
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 ascertained by clinical examination and brain imaging.
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 least 3 months for men following the last dose of study treatment (this must include a barrier method such as condom or diaphragm with spermicidal gel). Women of reproductive potential are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male patients with a nonpregnant female partner of childbearing potential and a woman of childbearing potential, 1 of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended:
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 reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Birth control methods unacceptable for this study include the following:
Periodic abstinence (calendar, symptothermal, or post-ovulation methods)

Where it is running

Harbin Medical University Cancer Hospital — Harbin, Heiljiang Province, China (enrolling)
Liaoning Cancer Hospital — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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