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A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 in Patients With Advanced Solid Tumors

NCT06783569•JiaRay Group

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a 2-part, first-in-human, open-label study to determine the safety and tolerability and preliminary efficacy of JR8603 in patients with locally advanced or metastatic solid tumors who have progressed after or are intolerant to standard therapies. The study will include a Dose Escalation Part and a Dose Expansion Part. JR8603 will be administered as a short IV infusion on Days 1, 8, and 15 of continuous 28-day cycles. Safety and tolerability of JR8603 will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. All patients will be assessed for response using Response Criteria for Evaluation in Solid Tumors (RECIST) v1.1, with computed tomography (CT) or magnetic resonance imaging (MRI) occurring at screening within 28 days of first dose, then every 8 weeks (±7 days) after Cycle 1 Day 1 (C1D1) for the first year and every 12 weeks (±7 days) thereafter. Serial blood samples for determination of PK will be collected.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years of age.
•2. 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.
•3. Measurable disease per RECIST v1.1.
•4. Life expectancy ≥3 months.
•5. Adequate organ and bone marrow function defined by:
•1. Absolute neutrophil count (ANC) ≥1.5 × 109/L (≥1500/mm3)
•2. Platelet count ≥100 × 109/L (≥100,000/mm3) (no platelet transfusion within 14 days prior to enrollment)
•3. Total bilirubin ≤1.5 × upper limit of normal (ULN), unless known Gilbert syndrome (≤3 × ULN) has been diagnosed
•4. AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases
•5. Estimated creatinine clearance by the Cockcroft-Gault or estimated glomerular filtration rate (eGFR) of ≥60 mL/min
+27 more criteria

Exclusion Criteria

•1. 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.
•2. 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) prior to start of study drug treatment.
•3. Major surgery within 3 weeks prior to start of study drug treatment.
•4. 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 acute radiotherapy-related toxicities.
•5. 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 arrhythmia requiring medication (Grade ≥2, according to NCI CTCAE v5.0), myocardial infarction within 6 months prior to starting study drug treatment, congenital long QT syndrome or QT interval corrected for heart rate using Fridericia's formula (QTcF) \>470 msec at screening, and any other significant or unstable concurrent cardiac illness.
•6. Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
•7. 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 of the Investigator, present a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
•8. 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 impair or prohibit a patient's participation in the study).
•9. 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 treated HBV infection who are antigen negative, patients with a prior history of treated HCV infection who are HCV RNA undetectable, or patients with HIV who are on stable anti-retroviral therapy and have an undetectable viral load may be enrolled.
•10. Pregnant (or intending to become pregnant) or breastfeeding.

Locations (2)

Harbin Medical University Cancer Hospital

Harbin, Heiljiang Province, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Key Dates

Start Date

December 31, 2024

Primary Completion Date

May 1, 2026

Completion Date

July 1, 2026

Last Updated

September 9, 2025

Enrollment

ESTIMATED participants

Conditions

Solid TumorsGastric CancerEsophagogastric Juction CancerColorectal Cancer

Interventions

JR8603

DRUG

Contacts

Sam Chu

CONTACT

760-351-6988 samchu@jiaraygroup.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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